An observational study in Surgical Incision, Ulcer Foot and Ulcer Venous, sponsored by Smith & Nephew, Inc.. Terminated at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Smith & Nephew, Inc. · Observational
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. The study comprises the Post Market Clinical Follow-up (PMCF) for a new variant of an established product. PICO 14 is based on another dressing called PICO.
The primary objective is to evaluate functional performance of PICO 14 through verification of delivery of negative pressure and wound exudate management.
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's enrollment of 45 is below the median of 154 across 97 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Smith & Nephew, Inc. is the lead sponsor of 132 studies on the registry; 10 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Seventy patients with Chronic open wounds (pressure ulcers, venous leg ulcers, diabetes-related foot ulcers, dehisced surgical wounds) and Closed surgical incisions, will be recruited to the study and will receive therapy with PICO 14. There will be a minimum of 10 of each of the following wound type; venous leg ulcers, diabetes-related foot ulcers, pressure ulcers, dehisced surgical wounds and post-operative incisions. The patients will be recruited from up to 7 sites in the United Kingdom, EU, and US, Canada. Sites failing to enroll may be replaced.
Closed Incisions ONLY:
Chronic wounds ONLY:
Patients with any chronic wound* which the treating clinician deems is suitable for management with single-use disposable NPWT where it is expected that the therapy will applied for up to 28 days.
Dehisced surgical wounds ONLY:
Patients with dehisced wounds in which the clinician believes is suitable for PICO therapy where therapy is expected to be applied for up to 28 days.
Exclusion Criteria:
Any Closed incision treated with PICO 14, for closed Surgical incisions this will be for 14 days post-surgery and with a 30 day follow up.
Device: PICO 14 single-use Negative Pressure Wound Therapy System
Any Chronic/Dehisced Surgical wound treated with PICO 14, for chronic and dehisced wounds this will be for up to 28 days therapy and no follow-up.
Device: PICO 14 single-use Negative Pressure Wound Therapy System
The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.
Delivery of Nominal -80mmHg Negative Pressure
Delivery of nominal -80mmHg negative pressure over the treatment period was measured by download of the built-in data chip from the PICO 14 devices to collect NPWT delivery status. This data was summarized to provide the average negative pressure delivery overall and for both closed incisions and chronic/dehisced surgical wounds.
Time frame: Day 30
Exudate Management: Occurrence of No Exudate Leaks
Exudate management was measured by the number of participants with no exudate leaks identified by the clinician at any point over the treatment period, up to 30 days.
Time frame: Up to 30 Days
Scar Quality Measured by The Patient and Observer Scar Assessment Scale (POSAS): Closed Incision Only
The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive scale that is designed for the evaluation of all types of scars by professionals and patients. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically and make up a 'Total Score' of the Patient and Observer Scale. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc.), and goes up to the worst imaginable. The Total Score is provided for both the Patient Scale and Observer Scale at Day 14 \& Day 30. The Total Score for both scales was calculated by summing up the scores of each of the six items. The Total Score ranged from 6 to 60 with a lower score indicating a better outcome.
Time frame: Day 14 and Day 30
Number of Participants With Surgical Site Infections (SSC): Closed Incisions Only
Incidence of Surgical Site Infections (SSI) as defined by The Centers for Disease Control and Prevention (CDC) criteria, for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants with an incision that is clinically infected were categorized as either 'Yes' or 'No' (e.g., Is Incision Clinically Infected: Yes or No).
Time frame: Day 7, Day 14, and Day 30
Number of Participants With Surgical Site Complication (SSC): Closed Incisions Only
Incidence of Surgical Site Complication (SSC) for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants where dehiscence of incision occurred, were categorized as either 'Yes' or 'No' (e.g., Incision dehisced: Yes or No).
Time frame: Day 7, Day 14, and Day 30
Condition of Peri-Wound Skin Assessed Through Visual Inspection at 7, 14 and 30 Days: Closed Incisions Only
The clinician assessed the condition of the surrounding skin of closed incisions at Day 7, Day 14, and Day 30. The condition of skin was categorized as the number of participants where any of the following characteristics apply: * Healthy * Fragile * Inflamed * Erythematous * Oedematous * Eczematous * Macerated * Bruising * Dry and flaky * Other
Time frame: Day 7, Day 14, and Day 30
Level of Pain - Visual Analog Score (VAS): Closed Incisions Only
Level of pain on dressing application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 14 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.
Time frame: Up to 14 Days
Patient Satisfaction During Wear - Performance: Closed Incisions Only
Patient satisfaction in performance at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following: * Overall performance * Comfort during wear * Noise level * Discreetness * Portability
Time frame: Day 7, Day 14, and Day 30
Patient Satisfaction During Wear - Interference With Daily Living: Closed Incisions Only
Patient satisfaction during wear in interference with daily living at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following: * Showering * Sleeping * Socializing * Working
Time frame: Day 7, Day 14, and Day 30
Ease of Application and Removal: Closed Incisions Only
Ease of application and removal of the PICO 14 dressing for Closed Incisions determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either 'Yes' or 'No'.
Time frame: Up to 14 days
Dressing Wear Time: Closed Incisions Only
Overall dressing wear time in days for Closed Incisions only.
Time frame: Up to 14 days
Dressing Conformability: Closed Incisions Only
Dressing conformability to the closed incision wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either 'Yes' or 'No'.
Time frame: Up to 14 days
Number of Dressings Used: Closed Incisions Only
Dressing change frequency summarized as the number of dressings used per participants for Closed Incisions.
Time frame: Up to 14 days
Reason for Dressing Change: Closed Incisions Only
Reason for dressing change for Closed Incisions only. Count of occurrences by dressing were categorized as 'Yes' or 'No': * Routine dressing change * Inadequate exudate management * Pain/discomfort * Dressing damaged * Dressing fell off * Patient removed dressing * Adverse Event * Surgical procedure * Safety alarm * Dressing components not in place * No vacuum * other
Time frame: Up to 14 days
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Closed Incision Only
Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 14) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?
Time frame: Day 14
Number of Participants With Clinical Infection: Chronic and Dehisced Surgical Wounds Only
Count of participants with presence of infection as determined by the clinical signs and symptoms at Day 0, Day 7, Day 14, Day 21, and Day 28 for Chronic and Dehisced Surgical Wounds (i.e., clinically infected: 'Yes' or 'No').
Time frame: Day 0, Day 7, Day 14, Day 21, and Day 28
Appearance of the Wound by Size: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by size measured by the length and width in centimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.
Time frame: Screening and Day 28
Appearance of the Wound by Depth: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by depth measured in millimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.
Time frame: Screening and Day 28
Appearance of the Wound by Presence of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by number of participants with the presence of necrotic tissue (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.
Time frame: Screening and Day 28
Appearance of the Wound by Necrotic Tissue Amount: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by amount of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: * \<25% of wound bed covered * 25% to 50% of wound covered * 50% to \< 75% of wound covered * 75% to 100% of wound covered
Time frame: Screening and Day 28
Appearance of the Wound by Type of Necrotic Tissue: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by type of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: * White/grey non-viable tissue * Non-adherent, yellow slough * Loosely adherent, yellow slough * Adherent, soft, black eschar * Firmly adherent, hard/black eschar
Time frame: Screening and Day 28
Appearance of the Wound by Granulation Tissue: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by granulation tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: * Skin intact or partial thickness wound * Bright, beefy red; 75% to 100% of wound filled \&/or tissue overgrowth * Bright, beefy red; \< 75% \& \>25% of wound filled * Pink, \&/or dull, dusky red \&/or fills \<25% of wound * No granulation tissue present
Time frame: Screening and Day 28
Appearance of the Wound by Epithelialization: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by epithelialization at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: * 100% wound covered, surface intact * 75% to \< 100% wound covered \&/or epithelial tissue extends to \> 0.5 cm into wound bed * 50% to \< 75% wound covered \&/or epithelial tissue extends to \< 0.5 cm into wound bed * 25% to \< 50% wound covered * \< 25% wound covered
Time frame: Screening and Day 28
Appearance of the Wound by Presence of Exudate: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by number of participants with presence of exudate (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.
Time frame: Screening and Day 28
Appearance of the Wound by Level of Exudate: Chronic and Dehisced Surgical Wounds Only
Appearance of the wound by number of participants level of exudate at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as: * Light * Moderate * Heavy
Time frame: Screening and Day 28
Condition of Peri-Wound Skin Assessed Through Visual Inspection at Day 0, Day 7, Day 14, Day 21, and Day 28 Days: Chronic and Dehisced Surgical Wounds Only
The clinician assessed the condition of the surrounding skin of Chronic and Dehisced Surgical Wounds at Day 0, Day 7, Day 14, Day 21, and Day 28. The condition of skin was categorized as the number of participants where any of the following characteristics apply: * Normal * Erythematous * Oedematous * Eczematous * Excoriated * Macerated * Indurated * Other
Time frame: Day 0, Day 7, Day 14, Day 21, and Day 28
Percentage Change in Area of Wound: Chronic and Dehisced Surgical Wounds Only
The reference wound area captured at each study visit. Percentage change in area calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.
Time frame: Day 7, Day 14, Day 21, and Day 28
Percentage Change in Volume of Wound: Chronic and Dehisced Surgical Wounds Only
The reference wound volume captured at each study visit. Percentage change in volume calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.
Time frame: Day 7, Day 14, Day 21, and Day 28
Level of Pain - Visual Analog Score (VAS): Chronic and Dehisced Surgical Wounds Only
Level of pain on application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 28 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.
Time frame: Up to 28 days
Patient Satisfaction During Wear - Performance: Chronic and Dehisced Surgical Wounds Only
Patient satisfaction in performance at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following: * Overall performance * Comfort during wear * Noise level * Discreetness * Portability
Time frame: Day 14 and Day 28
Patient Satisfaction During Wear - Interference With Daily Living: Chronic and Dehisced Surgical Wounds Only
Patient satisfaction during wear in interference with daily living at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following: * Showering * Sleeping * Socializing * Working
Time frame: Day 14 and Day 28
Ease of Application and Removal: Chronic and Dehisced Surgical Wounds Only
Ease of application and removal of the PICO 14 dressing for Chronic and Dehisced Surgical Wounds determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either 'Yes' or 'No'.
Time frame: Up to 28 days
Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only
Dressing wear time in days summarized for Chronic and Dehisced Surgical Wounds over the treatment period up to 28 days.
Time frame: Up to 28 days
Dressing Conformability: Chronic and Dehisced Surgical Wounds Only
Dressing conformability to the wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either 'Yes' or 'No'.
Time frame: Up to 28 days
Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only
Dressing change frequency summarized as the number of dressings used per participant for Chronic and Dehisced Surgical Wounds
Time frame: Up to 28 days
Reason for Dressing Change: Chronic and Dehisced Surgical Wounds Only
Reason for dressing change for Chronic and Dehisced Surgical Wounds only. Count of occurrences by dressing were categorized as 'Yes' or 'No': * Routine dressing change * Inadequate exudate management * Pain/discomfort * Dressing damaged * Dressing fell off * Patient removed dressing * Adverse Event * Surgical procedure * Safety alarm * Dressing components not in place * No vacuum * other
Time frame: Up to 28 days
Clinician Acceptability of PICO 14 at Discontinuation of Therapy: Chronic and Dehisced Surgical Wounds Only
Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 28) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?
Time frame: Day 28
| Milestone | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|---|
| Started | 25 | 19 |
| Completed | 20 | 13 |
| Not completed | 5 | 6 |
| Withdrew: Participant withdrawn: non-compliance | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Adverse event | 0 | 4 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Participant tested positive for covid-19 and is in isolation | 0 | 1 |
| Withdrew: Withdrawn by participant upon experiencing adverse event. | 1 | 0 |
Delivery of nominal -80mmHg negative pressure over the treatment period was measured by download of the built-in data chip from the PICO 14 devices to collect NPWT delivery status. This data was summarized to provide the average negative pressure delivery overall and for both closed incisions and chronic/dehisced surgical wounds.
| millimeters of mercury (mmHg) | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds | PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) |
|---|---|---|---|
| Delivery of Nominal -80mmHg Negative Pressure | -77.2 ± 7.7 | -74.7 ± 11.4 | -76.2 ± 9.3 |
Exudate management was measured by the number of participants with no exudate leaks identified by the clinician at any point over the treatment period, up to 30 days.
| Participants | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds | PICO 14 Overall (Closed Incisions & Chronic/Dehisced Wounds) |
|---|---|---|---|
| Exudate Management: Occurrence of No Exudate Leaks | 13 | 8 | 21 |
The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive scale that is designed for the evaluation of all types of scars by professionals and patients. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically and make up a 'Total Score' of the Patient and Observer Scale. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc.), and goes up to the worst imaginable. The Total Score is provided for both the Patient Scale and Observer Scale at Day 14 \& Day 30. The Total Score for both scales was calculated by summing up the scores of each of the six items. The Total Score ranged from 6 to 60 with a lower score indicating a better outcome.
| score on a scale | PICO 14 Closed Incisions |
|---|---|
| Day 14: Patient Scale Total Score | 18.9 ± 11.9 |
| Day 14: Observer Scale Total Score | 16.3 ± 9 |
| Day 30: Patient Scale Total Score | 19.5 ± 10.6 |
| Day 30: Observer Scale Total Score | 13.7 ± 7.4 |
Incidence of Surgical Site Infections (SSI) as defined by The Centers for Disease Control and Prevention (CDC) criteria, for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants with an incision that is clinically infected were categorized as either 'Yes' or 'No' (e.g., Is Incision Clinically Infected: Yes or No).
| Participants | PICO 14 Closed Incisions |
|---|---|
| Day 7: Is Incision Clinically Infected — Yes | 0 |
| Day 7: Is Incision Clinically Infected — No | 8 |
| Day 14: Is Incision Clinically Infected — Yes | 2 |
| Day 14: Is Incision Clinically Infected — No | 0 |
| Day 30: Is Incision Clinically Infected — Yes | 0 |
| Day 30: Is Incision Clinically Infected — No | 2 |
Incidence of Surgical Site Complication (SSC) for any incision that had not healed by the given assessment at Day 7, Day 14, and Day 30. The number of participants where dehiscence of incision occurred, were categorized as either 'Yes' or 'No' (e.g., Incision dehisced: Yes or No).
| Participants | PICO 14 Closed Incisions |
|---|---|
| Day 7: Incision Dehisced — Yes | 0 |
| Day 7: Incision Dehisced — No | 8 |
| Day 14: Incision Dehisced — Yes | 1 |
| Day 14: Incision Dehisced — No | 1 |
| Day 30: Incision Dehisced — Yes | 1 |
| Day 30: Incision Dehisced — No | 1 |
The clinician assessed the condition of the surrounding skin of closed incisions at Day 7, Day 14, and Day 30. The condition of skin was categorized as the number of participants where any of the following characteristics apply: * Healthy * Fragile * Inflamed * Erythematous * Oedematous * Eczematous * Macerated * Bruising * Dry and flaky * Other
| Participants | PICO 14 Closed Incisions |
|---|---|
| Day 7: Healthy | 18 |
| Day 7: Fragile | 0 |
| Day 7: Inflamed | 0 |
| Day 7: Erythematous | 0 |
| Day 7: Oedematous | 0 |
| Day 7: Eczematous | 0 |
| Day 7: Macerated | 0 |
| Day 7: Bruising | 11 |
| Day 7: Dry and flaky | 0 |
| Day 7: Other | 0 |
| Day 14: Healthy | 15 |
| Day 14: Fragile | 1 |
| Day 14: Inflamed | 1 |
| Day 14: Erythematous | 2 |
| Day 14: Oedematous | 1 |
| Day 14: Eczematous | 0 |
| Day 14: Macerated | 2 |
| Day 14: Bruising | 4 |
| Day 14: Dry and flaky | 1 |
| Day 14: Other | 0 |
| Day 30: Healthy | 20 |
| Day 30: Fragile | 0 |
| Day 30: Inflamed | 0 |
| Day 30: Erythematous | 1 |
| Day 30: Oedematous | 0 |
| Day 30: Eczematous | 0 |
| Day 30: Macerated | 1 |
| Day 30: Bruising | 0 |
| Day 30: Dry and flaky | 1 |
| Day 30: Other | 0 |
Level of pain on dressing application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 14 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.
| score on a scale | PICO 14 Closed Incisions |
|---|---|
| Level of Pain: Dressing Application | 0.5 ± 1.3 |
| Level of Pain: During Wear | 2.5 ± 2.5 |
| Level of Pain: Dressing Removal | 1.3 ± 1.9 |
Patient satisfaction in performance at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following: * Overall performance * Comfort during wear * Noise level * Discreetness * Portability
| Participants | PICO 14 Closed Incisions |
|---|---|
| Day 7: Overall performance — Yes | 20 |
| Day 7: Overall performance — No | 0 |
| Day 7: Comfort during wear — Yes | 19 |
| Day 7: Comfort during wear — No | 1 |
| Day 7: Noise level — Yes | 18 |
| Day 7: Noise level — No | 2 |
| Day 7: Discreetness — Yes | 20 |
| Day 7: Discreetness — No | 0 |
| Day 7: Portability — Yes | 18 |
| Day 7: Portability — No | 2 |
| Day 14: Overall performance — Yes | 18 |
| Day 14: Overall performance — No | 1 |
| Day 14: Comfort during wear — Yes | 16 |
| Day 14: Comfort during wear — No | 3 |
| Day 14: Noise level — Yes | 16 |
| Day 14: Noise level — No | 3 |
| Day 14: Discreetness — Yes | 17 |
| Day 14: Discreetness — No | 2 |
| Day 14: Portability — Yes | 13 |
| Day 14: Portability — No | 6 |
| Day 30: Overall performance — Yes | 13 |
| Day 30: Overall performance — No | 0 |
| Day 30: Comfort during wear — Yes | 11 |
| Day 30: Comfort during wear — No | 2 |
| Day 30: Noise level — Yes | 10 |
| Day 30: Noise level — No | 3 |
| Day 30: Discreetness — Yes | 13 |
| Day 30: Discreetness — No | 0 |
| Day 30: Portability — Yes | 12 |
| Day 30: Portability — No | 1 |
Patient satisfaction during wear in interference with daily living at Day 7, Day 14, and Day 30 (follow-up) measured by response of 'Yes' or 'No' to the following: * Showering * Sleeping * Socializing * Working
| Participants | PICO 14 Closed Incisions |
|---|---|
| Day 7: Showering — Yes | 8 |
| Day 7: Showering — No | 3 |
| Day 7: Sleeping — Yes | 18 |
| Day 7: Sleeping — No | 2 |
| Day 7: Socializing — Yes | 13 |
| Day 7: Socializing — No | 0 |
| Day 7: Working — Yes | 2 |
| Day 7: Working — No | 1 |
| Day 14: Showering — Yes | 10 |
| Day 14: Showering — No | 3 |
| Day 14: Sleeping — Yes | 16 |
| Day 14: Sleeping — No | 3 |
| Day 14: Socializing — Yes | 16 |
| Day 14: Socializing — No | 0 |
| Day 14: Working — Yes | 2 |
| Day 14: Working — No | 3 |
| Day 30: Showering — Yes | 5 |
| Day 30: Showering — No | 2 |
| Day 30: Sleeping — Yes | 11 |
| Day 30: Sleeping — No | 2 |
| Day 30: Socializing — Yes | 11 |
| Day 30: Socializing — No | 1 |
| Day 30: Working — Yes | 4 |
| Day 30: Working — No | 1 |
Ease of application and removal of the PICO 14 dressing for Closed Incisions determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either 'Yes' or 'No'.
| dressings | PICO 14 Closed Incisions |
|---|---|
| Was it easy to apply the dressing — Yes | 48 |
| Was it easy to apply the dressing — No | 0 |
| Was it easy to remove the dressing — Yes | 46 |
| Was it easy to remove the dressing — No | 2 |
Overall dressing wear time in days for Closed Incisions only.
| days | PICO 14 Closed Incisions |
|---|---|
| Dressing Wear Time: Closed Incisions Only | 5.7 ± 2.1 |
Dressing conformability to the closed incision wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either 'Yes' or 'No'.
| dressings | PICO 14 Closed Incisions |
|---|---|
| Yes | 48 |
| No | 0 |
Dressing change frequency summarized as the number of dressings used per participants for Closed Incisions.
| dressings per participant | PICO 14 Closed Incisions |
|---|---|
| Number of Dressings Used: Closed Incisions Only | 2.2 ± 1.0 |
Reason for dressing change for Closed Incisions only. Count of occurrences by dressing were categorized as 'Yes' or 'No': * Routine dressing change * Inadequate exudate management * Pain/discomfort * Dressing damaged * Dressing fell off * Patient removed dressing * Adverse Event * Surgical procedure * Safety alarm * Dressing components not in place * No vacuum * other
| dressings | PICO 14 Closed Incisions |
|---|---|
| Routine dressing change — Yes | 37 |
| Routine dressing change — No | 14 |
| Inadequate exudate management — Yes | 5 |
| Inadequate exudate management — No | 46 |
| Pain/discomfort — Yes | 0 |
| Pain/discomfort — No | 51 |
| Dressing damaged — Yes | 0 |
| Dressing damaged — No | 51 |
| Dressing fell off — Yes | 0 |
| Dressing fell off — No | 51 |
| Patient removed dressing — Yes | 1 |
| Patient removed dressing — No | 50 |
| Adverse Event — Yes | 4 |
| Adverse Event — No | 47 |
| Surgical procedure — Yes | 0 |
| Surgical procedure — No | 51 |
| Safety alarm — Yes | 1 |
| Safety alarm — No | 50 |
| Dressing components not in place — Yes | 1 |
| Dressing components not in place — No | 50 |
| No vacuum — Yes | 2 |
| No vacuum — No | 49 |
| Other — Yes | 3 |
| Other — No | 48 |
Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 14) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?
| Participants | PICO 14 Closed Incisions |
|---|---|
| Yes | 19 |
| No | 0 |
Count of participants with presence of infection as determined by the clinical signs and symptoms at Day 0, Day 7, Day 14, Day 21, and Day 28 for Chronic and Dehisced Surgical Wounds (i.e., clinically infected: 'Yes' or 'No').
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Day 0: Clinically infected — Yes | 0 |
| Day 0: Clinically infected — No | 16 |
| Day 7: Clinically infected — Yes | 0 |
| Day 7: Clinically infected — No | 16 |
| Day 14: Clinically infected — Yes | 0 |
| Day 14: Clinically infected — No | 15 |
| Day 21: Clinically infected — Yes | 0 |
| Day 21: Clinically infected — No | 14 |
| Day 28: Clinically infected — Yes | 0 |
| Day 28: Clinically infected — No | 13 |
Appearance of the wound by size measured by the length and width in centimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.
| centimeters (cm) | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Screening: Length | 5.9 ± 5.2 |
| Day 28: Length | 3.1 ± 2.2 |
| Screening: Width | 4.5 ± 2.9 |
| Day 28: Width | 3.1 ± 2.4 |
Appearance of the wound by depth measured in millimeters at screening and Day 28 for Chronic and Dehisced Surgical Wounds only.
| millimeters (mm) | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Screening: Depth | 10.6 ± 11.1 |
| Day 28: Depth | 3.2 ± 5.7 |
Appearance of the wound by number of participants with the presence of necrotic tissue (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Screening: Presence of Necrotic Tissue — Yes | 8 |
| Screening: Presence of Necrotic Tissue — No | 8 |
| Day 28: Presence of Necrotic Tissue — Yes | 3 |
| Day 28: Presence of Necrotic Tissue — No | 10 |
Appearance of the wound by amount of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: * \<25% of wound bed covered * 25% to 50% of wound covered * 50% to \< 75% of wound covered * 75% to 100% of wound covered
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Screening: Necrotic Tissue Amount — <25% of wound bed covered | 5 |
| Screening: Necrotic Tissue Amount — 25% to 50% of wound covered | 2 |
| Screening: Necrotic Tissue Amount — 50% to < 75% of wound covered | 1 |
| Screening: Necrotic Tissue Amount — 75% to 100% of wound covered | 0 |
| Day 28: Necrotic Tissue Amount — <25% of wound bed covered | 2 |
| Day 28: Necrotic Tissue Amount — 25% to 50% of wound covered | 0 |
| Day 28: Necrotic Tissue Amount — 50% to < 75% of wound covered | 1 |
| Day 28: Necrotic Tissue Amount — 75% to 100% of wound covered | 0 |
Appearance of the wound by type of necrotic tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: * White/grey non-viable tissue * Non-adherent, yellow slough * Loosely adherent, yellow slough * Adherent, soft, black eschar * Firmly adherent, hard/black eschar
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Screening: Type of Necrotic Tissue — White/grey non-viable tissue | 0 |
| Screening: Type of Necrotic Tissue — Non-adherent, yellow slough | 3 |
| Screening: Type of Necrotic Tissue — Loosely adherent, yellow slough | 5 |
| Screening: Type of Necrotic Tissue — Adherent, soft, black eschar | 0 |
| Screening: Type of Necrotic Tissue — Firmly adherent, hard/black eschar | 0 |
| Day 28: Type of Necrotic Tissue — White/grey non-viable tissue | 0 |
| Day 28: Type of Necrotic Tissue — Non-adherent, yellow slough | 1 |
| Day 28: Type of Necrotic Tissue — Loosely adherent, yellow slough | 2 |
| Day 28: Type of Necrotic Tissue — Adherent, soft, black eschar | 0 |
| Day 28: Type of Necrotic Tissue — Firmly adherent, hard/black eschar | 0 |
Appearance of the wound by granulation tissue at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: * Skin intact or partial thickness wound * Bright, beefy red; 75% to 100% of wound filled \&/or tissue overgrowth * Bright, beefy red; \< 75% \& \>25% of wound filled * Pink, \&/or dull, dusky red \&/or fills \<25% of wound * No granulation tissue present
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Screening: Granulation Tissue — Skin intact or partial thickness wound | 0 |
| Screening: Granulation Tissue — Bright, beefy red; 75% to 100% of wound filled &/or tissue overgrowth | 7 |
| Screening: Granulation Tissue — Bright, beefy red; < 75% & >25% of wound filled | 6 |
| Screening: Granulation Tissue — Pink, &/or dull, dusky red &/or fills <25% of wound | 3 |
| Screening: Granulation Tissue — No granulation tissue present | 0 |
| Day 28: Granulation Tissue — Skin intact or partial thickness wound | 1 |
| Day 28: Granulation Tissue — Bright, beefy red; 75% to 100% of wound filled &/or tissue overgrowth | 5 |
| Day 28: Granulation Tissue — Bright, beefy red; < 75% & >25% of wound filled | 6 |
| Day 28: Granulation Tissue — Pink, &/or dull, dusky red &/or fills <25% of wound | 1 |
| Day 28: Granulation Tissue — No granulation tissue present | 0 |
Appearance of the wound by epithelialization at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as number of participants with: * 100% wound covered, surface intact * 75% to \< 100% wound covered \&/or epithelial tissue extends to \> 0.5 cm into wound bed * 50% to \< 75% wound covered \&/or epithelial tissue extends to \< 0.5 cm into wound bed * 25% to \< 50% wound covered * \< 25% wound covered
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Screening: Epithelialization — 100% wound covered, surface intact | 0 |
| Screening: Epithelialization — 75% to < 100% wound covered &/or epithelial tissue extends to > 0.5 cm into wound bed | 0 |
| Screening: Epithelialization — 50% to < 75% wound covered &/or epithelial tissue extends to < 0.5 cm into wound bed | 0 |
| Screening: Epithelialization — 25% to < 50% wound covered | 0 |
| Screening: Epithelialization — < 25% wound covered | 16 |
| Day 28: Epithelialization — 100% wound covered, surface intact | 0 |
| Day 28: Epithelialization — 75% to < 100% wound covered &/or epithelial tissue extends to > 0.5 cm into wound bed | 1 |
| Day 28: Epithelialization — 50% to < 75% wound covered &/or epithelial tissue extends to < 0.5 cm into wound bed | 1 |
| Day 28: Epithelialization — 25% to < 50% wound covered | 2 |
| Day 28: Epithelialization — < 25% wound covered | 9 |
Appearance of the wound by number of participants with presence of exudate (Yes/No) at screening and Day 28 for Chronic and Dehisced Surgical Wounds.
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Screening: Presence of Exudate — Yes | 15 |
| Screening: Presence of Exudate — No | 1 |
| Day 28: Presence of Exudate — Yes | 12 |
| Day 28: Presence of Exudate — No | 1 |
Appearance of the wound by number of participants level of exudate at screening and Day 28 for Chronic and Dehisced Surgical Wounds categorized as: * Light * Moderate * Heavy
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Screening: Level of Exudate — Light | 2 |
| Screening: Level of Exudate — Moderate | 12 |
| Screening: Level of Exudate — Heavy | 1 |
| Day 28: Level of Exudate — Light | 6 |
| Day 28: Level of Exudate — Moderate | 5 |
| Day 28: Level of Exudate — Heavy | 1 |
The clinician assessed the condition of the surrounding skin of Chronic and Dehisced Surgical Wounds at Day 0, Day 7, Day 14, Day 21, and Day 28. The condition of skin was categorized as the number of participants where any of the following characteristics apply: * Normal * Erythematous * Oedematous * Eczematous * Excoriated * Macerated * Indurated * Other
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Day 0 : Normal | 7 |
| Day 0 : Erythematous | 2 |
| Day 0 : Oedematous | 4 |
| Day 0 : Eczematous | 0 |
| Day 0 : Excoriated | 1 |
| Day 0 : Macerated | 3 |
| Day 0 : Indurated | 0 |
| Day 0 : Other | 2 |
| Day 7 : Normal | 6 |
| Day 7 : Erythematous | 2 |
| Day 7 : Oedematous | 3 |
| Day 7 : Eczematous | 0 |
| Day 7 : Excoriated | 1 |
| Day 7 : Macerated | 5 |
| Day 7 : Indurated | 0 |
| Day 7 : Other | 4 |
| Day 14 : Normal | 5 |
| Day 14 : Erythematous | 3 |
| Day 14 : Oedematous | 3 |
| Day 14 : Eczematous | 0 |
| Day 14 : Excoriated | 3 |
| Day 14 : Macerated | 5 |
| Day 14 : Indurated | 0 |
| Day 14 : Other | 3 |
| Day 21 : Normal | 5 |
| Day 21 : Erythematous | 1 |
| Day 21 : Oedematous | 2 |
| Day 21 : Eczematous | 1 |
| Day 21 : Excoriated | 1 |
| Day 21 : Macerated | 4 |
| Day 21 : Indurated | 0 |
| Day 21 : Other | 5 |
| Day 28 : Normal | 4 |
| Day 28 : Erythematous | 1 |
| Day 28 : Oedematous | 1 |
| Day 28 : Eczematous | 0 |
| Day 28 : Excoriated | 2 |
| Day 28 : Macerated | 4 |
| Day 28 : Indurated | 0 |
| Day 28 : Other | 3 |
The reference wound area captured at each study visit. Percentage change in area calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.
| percent change in wound area | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Day 7 | 17.5 ± 24.7 |
| Day 14 | 18.6 ± 31.0 |
| Day 21 | 42.2 ± 22.7 |
| Day 28 | 50.5 ± 24.0 |
The reference wound volume captured at each study visit. Percentage change in volume calculated and summarized using a Wilcoxon Signed Rank test from baseline to all post-baseline study visits at Day 7, Day 14, Day 21, and Day 28.
| percent change in wound volume | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Day 7 | 41.8 ± 30.3 |
| Day 14 | 52.3 ± 32.8 |
| Day 21 | 72.7 ± 30.8 |
| Day 28 | 79.3 ± 24.7 |
Level of pain on application, during wear and at dressing removal assessed by Visual Analog Score (VAS) scale over the 28 day treatment period. The VAS scale ranges from 0-10 with 0 being no pain and 10 being extreme pain.
| score on a scale | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Level of Pain: Dressing Application | 0.4 ± 1.4 |
| Level of Pain: During Wear | 1.1 ± 2.1 |
| Level of Pain: Dressing Removal | 1.5 ± 2.4 |
Patient satisfaction in performance at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following: * Overall performance * Comfort during wear * Noise level * Discreetness * Portability
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Day 14: Overall performance — Yes | 15 |
| Day 14: Overall performance — No | 0 |
| Day 14: Comfort during wear — Yes | 15 |
| Day 14: Comfort during wear — No | 0 |
| Day 14: Noise level — Yes | 15 |
| Day 14: Noise level — No | 0 |
| Day 14: Discreetness — Yes | 15 |
| Day 14: Discreetness — No | 0 |
| Day 14: Portability — Yes | 15 |
| Day 14: Portability — No | 0 |
| Day 28: Overall performance — Yes | 13 |
| Day 28: Overall performance — No | 0 |
| Day 28: Comfort during wear — Yes | 13 |
| Day 28: Comfort during wear — No | 0 |
| Day 28: Noise level — Yes | 13 |
| Day 28: Noise level — No | 0 |
| Day 28: Discreetness — Yes | 13 |
| Day 28: Discreetness — No | 0 |
| Day 28: Portability — Yes | 13 |
| Day 28: Portability — No | 0 |
Patient satisfaction during wear in interference with daily living at Day 14 and Day 28 measured by response of 'Yes' or 'No' to the following: * Showering * Sleeping * Socializing * Working
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Day 14: Showering — Yes | 8 |
| Day 14: Showering — No | 6 |
| Day 14: Sleeping — Yes | 15 |
| Day 14: Sleeping — No | 0 |
| Day 14: Socializing — Yes | 14 |
| Day 14: Socializing — No | 1 |
| Day 14: Working — Yes | 7 |
| Day 14: Working — No | 7 |
| Day 28: Showering — Yes | 8 |
| Day 28: Showering — No | 5 |
| Day 28: Sleeping — Yes | 13 |
| Day 28: Sleeping — No | 0 |
| Day 28: Socializing — Yes | 12 |
| Day 28: Socializing — No | 1 |
| Day 28: Working — Yes | 8 |
| Day 28: Working — No | 5 |
Ease of application and removal of the PICO 14 dressing for Chronic and Dehisced Surgical Wounds determined by overall count of dressings applied/removed based on responses to the questions "Was it easy to apply the dressing" and "Was it easy to remove the dressing" as either 'Yes' or 'No'.
| dressings | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Was it easy to apply the dressing — Yes | 112 |
| Was it easy to apply the dressing — No | 1 |
| Was it easy to remove the dressing — Yes | 105 |
| Was it easy to remove the dressing — No | 4 |
Dressing wear time in days summarized for Chronic and Dehisced Surgical Wounds over the treatment period up to 28 days.
| days | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Dressing Wear Time: Chronic and Dehisced Surgical Wounds Only | 3.6 ± 2.0 |
Dressing conformability to the wound measured by the number of responses to the question "Was the dressing conformable on the incision/wound?" as either 'Yes' or 'No'.
| dressings | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Yes | 112 |
| No | 0 |
Dressing change frequency summarized as the number of dressings used per participant for Chronic and Dehisced Surgical Wounds
| dressings per participant | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Number of Dressings Used: Chronic and Dehisced Surgical Wounds Only | 7.1 ± 3.3 |
Reason for dressing change for Chronic and Dehisced Surgical Wounds only. Count of occurrences by dressing were categorized as 'Yes' or 'No': * Routine dressing change * Inadequate exudate management * Pain/discomfort * Dressing damaged * Dressing fell off * Patient removed dressing * Adverse Event * Surgical procedure * Safety alarm * Dressing components not in place * No vacuum * other
| dressings | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Routine dressing change — Yes | 84 |
| Routine dressing change — No | 30 |
| Inadequate exudate management — Yes | 8 |
| Inadequate exudate management — No | 106 |
| Pain/discomfort — Yes | 0 |
| Pain/discomfort — No | 114 |
| Dressing damaged — Yes | 0 |
| Dressing damaged — No | 114 |
| Dressing fell off — Yes | 3 |
| Dressing fell off — No | 111 |
| Patient removed dressing — Yes | 0 |
| Patient removed dressing — No | 114 |
| Adverse Event — Yes | 2 |
| Adverse Event — No | 112 |
| Surgical procedure — Yes | 0 |
| Surgical procedure — No | 114 |
| Safety alarm — Yes | 2 |
| Safety alarm — No | 112 |
| Dressing components not in place — Yes | 0 |
| Dressing components not in place — No | 114 |
| No vacuum — Yes | 3 |
| No vacuum — No | 111 |
| Other — Yes | 17 |
| Other — No | 97 |
Acceptability of the device determined from the clinician's response (Yes/No) at discontinuation of therapy by participant (i.e., Day 28) to the question: Overall are you satisfied with the performance of the PICO 14 system (pump and PICO 14 dressing)?
| Participants | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|
| Yes | 13 |
| No | 0 |
Collected over Adverse events for closed incisions collected 14 days post-surgery with a further 16 days follow-up period, up to 30 days from initial application of treatment. Adverse events for chronic wounds and dehisced surgical wounds were collected up to 28 days during the therapy period with no follow up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PICO 14 Closed Incisions | 0/25 (0%) | 1/25 (4%) | 21/25 (84%) |
| PICO 14 Chronic/Dehisced Surgical Wounds | 1/19 (5.3%) | 3/19 (15.8%) | 11/19 (57.9%) |
| Event | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|---|
| ADMITTED TO HOSPITAL WITH A CHEST INFECTION.Respiratory, thoracic and mediastinal disorders | 0/25 | 1/19 |
| PATIENTS GENERAL HEALTH HAS QUICKLY DECLINED AND IS NOW AT END OF LIFEGeneral disorders | 0/25 | 1/19 |
| PATIENT HOSPITALISED WITH CHEST PAINGeneral disorders | 0/25 | 1/19 |
| WOUND INFECTIONInfections and infestations | 0/25 | 1/19 |
| ANEMIABlood and lymphatic system disorders | 1/25 | 0/19 |
| Event | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds |
|---|---|---|
| NAUSEAGastrointestinal disorders | 11/25 | 0/19 |
| VOMITINGGastrointestinal disorders | 5/25 | 0/19 |
| ILEUSGeneral disorders | 3/25 | 0/19 |
| PAINGastrointestinal disorders | 3/25 | 0/19 |
| TACHYCARDIACardiac disorders | 3/25 | 0/19 |
| LOW MAGNESIUMEndocrine disorders | 2/25 | 0/19 |
| LOW POST-OPERATIVE SODIUMBlood and lymphatic system disorders | 2/25 | 0/19 |
| MILD PAINGeneral disorders | 2/25 | 0/19 |
| RAISED WHITE BLOOD COUNTImmune system disorders | 2/25 | 0/19 |
| URINARY TRACT INFECTIONRenal and urinary disorders | 2/25 | 0/19 |
All participants who received the study device with available data.
| Age, Continuous(years) | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds | Total |
|---|---|---|---|
| Mean | 71.6 ± 10.2 | 71.3 ± 16.3 | 71.5 ± 13.0 |
| Sex: Female, Male(Participants) | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds | Total |
|---|---|---|---|
| Female | 16 | 13 | 29 |
| Male | 9 | 6 | 15 |
| Race/Ethnicity, Customized(Participants) | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds | Total |
|---|---|---|---|
| Race — Caucasian | 25 | 15 | 40 |
| Race — Black | 0 | 0 | 0 |
| Race — Asian | 0 | 0 | 0 |
| Race — Other | 0 | 4 | 4 |
| Region of Enrollment(participants) | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds | Total |
|---|---|---|---|
| United Kingdom | 25 | 16 | 41 |
| Germany | 0 | 3 | 3 |
| Body Mass Index (BMI)(kg/m^2) | PICO 14 Closed Incisions | PICO 14 Chronic/Dehisced Surgical Wounds | Total |
|---|---|---|---|
| Mean | 29.1 ± 4.6 | 30.0 ± 9.8 | 29.5 ± 7.1 |
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Smith & Nephew, Inc.