An interventional study of Silver-impregnated dressing and Telfa pad dressing in Surgical Site Infection, Cosmetic Appearance of Cesarean Scar and Post Operative Pain, sponsored by University of South Florida. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-14.
Sponsored by University of South Florida · Not applicable, Interventional, and Prevention
This study will investigate whether the placement of silver impregnated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver impregnated dressings are used compared to the Telfa pads.
The study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.
This is a randomized, prospective study involving 660 patients undergoing cesarean sections at Tampa General Hospital. The control group (n=330) will receive standard Telfa pad dressing and the treatment group (n=330) will receive the silver impregnated dressing.
The primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at the 1-week and 6-weeks post operative visits. The secondary objective is to assess the cosmetic outcome of the cesarean incision observed at the 1-week and 6-week post-operative visits. A plastic surgery investigator will also conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks.The tertiary objective is to evaluate the amount of narcotic and non narcotic medicine consumed during the hospitalization and query the patient with regards to pain involving the cesarean wound at 1 and 6 week post-operative visits
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 660 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Device: Telfa pad dressing
Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Device: Silver-impregnated dressing
Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Also known as: Silverlon
Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Also known as: Telfa pad
Percentage of Patients Who Develop a Surgical Site Infection
A surgical site infection involving the skin and subcutaneous tissue is defined as either * The presence of a purulent discharge from the wound on inspection, or * Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or * The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.
Time frame: from post operative day #1 through post operative day 30
Cosmetic Outcome of the Cesarean Section Incision
The following instruments will be used to determine the cosmetic outcome: • The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)
Time frame: Post operative day 7
Cosmetic Outcome of the Cesarean Section Incision
The following instruments will be used to determine the cosmetic outcome • The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)
Time frame: Six weeks post-operative
Reduction of Pain After Cesarean Delivery
The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded
Time frame: Immediately post operatively to hospital discharge
The Number of Participants Noting Pain at the One Week Post Cesarean Visit
Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.
Time frame: Post operative day 7
The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit
Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.
Time frame: 6 weeks post operative
Recruitment was from September 2013 through June 2016. The 6 week post operative visits were completed August 2016. Recruitment was at University of South Florida South Tampa Campus, Tampa General Hospital Healthpark Genesis and Tampa General Hospital Tampa Florida Labor and Delivery Triage.
| Milestone | Telfa Pad Dressing | Silver-impregnated Dressing |
|---|---|---|
| Started | 329 | 328 |
| Completed | 271 | 260 |
| Not completed | 58 | 68 |
| Withdrew: Ineligible skin incision | 1 | 2 |
| Withdrew: Ineligible uterine incision | 4 | 1 |
| Withdrew: Lost to follow-up | 53 | 65 |
A surgical site infection involving the skin and subcutaneous tissue is defined as either * The presence of a purulent discharge from the wound on inspection, or * Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or * The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.
| Participants | Telfa Pad Dressing | Silver-impregnated Dressing |
|---|---|---|
| Percentage of Patients Who Develop a Surgical Site Infection | 14 | 15 |
The following instruments will be used to determine the cosmetic outcome: • The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)
| score on a scale | Telfa Pad Dressing | Silver-impregnated Dressing |
|---|---|---|
| Cosmetic Outcome of the Cesarean Section Incision | 3.8 ± 1.8 | 3.7 ± 1.8 |
The following instruments will be used to determine the cosmetic outcome • The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)
| score on a scale | Telfa Pad Dressing | Silver-impregnated Dressing |
|---|---|---|
| Cosmetic Outcome of the Cesarean Section Incision | 11.4 ± 6.5 | 11.6 ± 6.5 |
The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded
| Morphine milligram equivalent | Telfa Pad Dressing | Silver-impregnated Dressing |
|---|---|---|
| Reduction of Pain After Cesarean Delivery | 90.0 (60 to 135) | 82.5 (52.5 to 120) |
Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.
| Participants | Telfa Pad Dressing | Silver-impregnated Dressing |
|---|---|---|
| The Number of Participants Noting Pain at the One Week Post Cesarean Visit | 23 | 21 |
Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.
| Participants | Telfa Pad Dressing | Silver-impregnated Dressing |
|---|---|---|
| The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit | 5 | 8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telfa Pad Dressing | 0/329 (0%) | 1/329 (0.3%) | 3/329 (0.9%) |
| Silver-impregnated Dressing | 0/328 (0%) | 2/328 (0.6%) | 2/328 (0.6%) |
| Event | Telfa Pad Dressing | Silver-impregnated Dressing |
|---|---|---|
| Readmission to hospitalSkin and subcutaneous tissue disorders | 1/329 | 2/328 |
| Event | Telfa Pad Dressing | Silver-impregnated Dressing |
|---|---|---|
| Skin reaction to adhesiveSkin and subcutaneous tissue disorders | 3/329 | 2/328 |
| Age, Categorical(Participants) | Telfa Pad Dressing | Silver-impregnated Dressing | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 329 | 328 | 657 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Telfa Pad Dressing | Silver-impregnated Dressing | Total |
|---|---|---|---|
| Mean | 31.0 ± 5.5 | 30.9 ± 5.6 | 31.0 ± 5.6 |
| Sex: Female, Male(Participants) | Telfa Pad Dressing | Silver-impregnated Dressing | Total |
|---|---|---|---|
| Female | 329 | 328 | 657 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Telfa Pad Dressing | Silver-impregnated Dressing | Total |
|---|---|---|---|
| United States | 329 | 328 | 657 |
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