An interventional study of Avance Solo NPWT System and Avance Solo Adapt NPWT System in Venous Leg Ulcer, Pressure Ulcer and Diabetic Foot Ulcer, sponsored by Molnlycke Health Care AB. Completed at 13 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Molnlycke Health Care AB · Not applicable, Interventional, and Treatment
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.
This investigation is designed as a prospective, open and non-comparative PMCF investigation to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt in low to moderate exuding chronic wounds. This is a multi-center study that will take place in approximately 5 European countries. The target subjects are male or female, 18 years or older with low to moderate exuding chronic wounds (pressure ulcers (N=68), diabetic foot ulcers (N=34), and venous leg ulcers (N=34)) suitable for NPWT as deemed by the investigator. Two different options of Negative Pressure Wound Therapies (NPWT) will be evaluated through this clinical investigation
A total of 136 subjects will receive treatment with the investigational devices within the intended use according to Instructions for Use (IfU): Group 1: 102 subjects in total, 34 subjects per indication (pressure ulcers, diabetic foot ulcers, and venous leg ulcers) treated with Avance®Solo and Group 2: 34 subjects with pressure ulcers treated with Avance®Solo Adapt. Subjects will be managed and monitored for a maximum of 4 weeks or until withdrawal from investigation for any reason.
The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will take into account all aspects of wound characteristics. Wound progression will be assessed by the Investigator at each follow-up visit and measured by three outcomes:
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 136 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Molnlycke Health Care AB is the lead sponsor of 58 studies on the registry; 7 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with negative pressure wound therapy for Venous leg ulcers, Diabetic foot ulcers, and Pressure ulcers.
Device: Avance Solo NPWT System
Treatment with negative pressure wound therapy for Pressure ulcers.
Device: Avance Solo Adapt NPWT System
Wound treatment with Avance Solo NPWT System for up to 28 days.
Wound treatment with Avance Solo Adapt NPWT System for up to 28 days.
Change in wound progress
Wound progress compared to last visit and assessed as: * Deteriorated * No change * Improved
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wound progress
Wound progress compared between baseline and final visit and assessed as: * Deteriorated * No change * Improved
Time frame: 28 days
Absolute change in wound area
Absolute change in wound area from baseline to all follow-up visits
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Absolute change in wound volume
Absolute change in wound volume from baseline to all follow-up visits
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Percentage change in wound area
Percentage change in wound area from baseline to all follow-up visits
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Percentage change in wound volume
Percentage change in wound volume from baseline to all follow-up visits
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue type
Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate amount
Change in exudate amount using a category scoring system from baseline to all follow-up visits. Amount: none, low, moderate, or high)
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate nature
Change in exudate nature using a category scoring system from baseline to all follow-up visits. Nature: serous, fibrinous, serosanguineous, sanguineous, seropurulent, purulent, foul purulent, heamopurulent, or hemorrhagic
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate odor
Change in exudate odor using a category scoring system from baseline to all follow-up visits. Odor: no odor, slight, moderate, strong, and very strong
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Peri-wound
Change in peri-wound skin condition from baseline to all follow-up visits using the following conditions: * Normal * Erythematous * Oedematous * Eczematous * Excoriated * Macerated * Indurated
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue in-growth
Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) with additional assessments in between when dressing is changed
Pain assessment
Subject evaluation of pain at Avance Solo dressing or Avance Solo Adapt Film removal using Numeric Rating Scale (NRS) at each follow-up visit.
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Trauma
Proportion of subjects with trauma to the wound site and surrounding skin for Avance Solo Border Dressing, fixation strips or Avance Solo Adapt Film at all follow-up visits.
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Quality of life assessed using Numeric Rating Scale (NRS)
Impact of everyday life by the systems will be captured through a NRS scale where the subject grade how much the treatment has affected the subject's daily life. 0 is equal to no influence and 10 to considerable influence on everyday life or unbearable. If replying \>0, the subject will state the presence or absence of the following causes: * Leakage of dressing * Impaired mobility * Difficulties in getting dressed * Pain * Odor
Time frame: 28 days
Alarms
Subject evaluation of the system properties (number of sounding alarms) assessed with a given scale at all follow-up visits * 0 * 1-5 * 6-10 * 11-15 * 16-20 * More than 20
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Compliance
Evaluate the compliance to the provided therapy by average number of hours per 24h that the system has not provided treatment since last visit.
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Ability to absorb and/or transport exudate via clinical judgement
Evaluation of the Systems ability to absorb and/or transport exudate assessed using a rating scale by the clinician/designee: * Very Poor * Poor * Good * Very Good
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Ease of application
Clinician evaluation of ease of application and removal of Avance®Solo or Avance®Solo Adapt using a Numeric Rating Scale (NRS) collected at baseline, and each follow-up visit.
Time frame: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Global satisfaction
Evaluate the investigator and subject global satisfaction of the systems in regards to: * Very dissatisfied * Dissatisfied * Neither satisfied or dissatisfied * Satisfied * Very satisfied
Time frame: 28 days
Product consumption
Product consumption of the utilized products for the system's, from baseline and final visit using the Avance Solo or Avance Solo Adapt NPWT System
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wear time
Evaluate Avance®Solo or Avance®Solo Adapt wear time in days from baseline to all follow-up visits including potential extra visits
Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Plan to share: No
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Molnlycke Health Care AB