Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds

Study Overview
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Brief Summary
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The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb® A + Ag wound dressing and rope within the certified indications and under the conditions of routine use.

Detailed Description
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This clinical investigation will be conducted as 3 weeks, multicentre, open, single-arm cohort study on patients presenting wounds at risk of infection or infected wounds. All wounds of the included patients will be treated with Suprasorb® A +Ag Antimicrobial Calcium Alginate Wound Dressings (and Suprasorb® A + Ag Antimicrobial Calcium Packing Rope - if required by the depth of the wound). At inclusion visit (V1, day 0), interim visit (V2, after 10 days ±3 days) and termination visit (V3 after 21 days ±3 days or earlier; as soon as the wound is epithelialized completely) patients will have clinical examination and wound area measurements.

Official Title
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Post-market Clinical Follow-up Study to Evaluate the Performance and Safety of Suprasorb® A + Ag Wound Dressing and Rope in the Treatment of Wounds at Risk of Infection and Infected Wounds

Conditions
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Pressure Ulcer, Arterial Ulcers, Venous Leg Ulcer, Diabetic Ulcers, Surgical Wound, Skin Graft

Intervention / Treatment
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* Device: Suprasorb® A + Ag wound dressing and rope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patient is legally capable Presence of a heavily exuding wound Presence of one of the following wounds: pressure ulcers arterial ulcers venous lower leg ulcers diabetic ulcers OR postoperative wound skin graft and donor sites Infected wound (TILI Score ≥ 5) or a wound with risk of infection (W.A.R. Score ≥ 3) Wound area between 4 and 100 cm2 It must be possible to display the entire wound area on one photo from a distance of 25-30 cm Patient has signed a written Informed Consent Exclusion Criteria: Treatment with Suprasorb® A + Ag Antimicrobial Calcium Algi-nate Wound Dressing and Rope or any silver containing dressing or topical drug during the last 3 weeks Known sensitivity to Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressing and Rope or any of their components Malignant wounds (tumor related wounds) Critical limb ischemia Infected wounds requiring systemic antibiotic therapy at baseline visit or infected wounds with surrounding skin requiring local an-tibiotics at baseline visit and/or during study conduct. Severe sensitive neuropathy (9-10 points on the Neuropathie-Symptom-Score (Diagnose und Therapie der sensomotorischen diabetischen Neuropathien. Diabetes und Stoffwechsel, 11, Suppl.2 (2002)) Planned amputation within the next 1 months A planned surgical operation in the region of the study wound within the next 4 weeks following inclusion Patient is not compliant regarding treatment of the underlying disease (e.g. compression) Dry wound Pregnancy or breast feeding Reliable severe malnutrition Patient is analphabet Participation in any clinical trial within the last 1 month and during participation in this study Legal incapacity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| wounds at risk of infection<br>Ideally 71 patients with wounds at risk of infection (W.A.R. Score ≥ 3) to be included. | Device: Suprasorb® A + Ag wound dressing and rope<br>* Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressings / Packing Rope are soft, conformable wound coverings with a high mannuronic acid content (mass per unit area ≥100 g/m2). The silver impregnated calcium alginate fibres react with wound exudate or blood to form a gel which creates a moist wound environment. The silver contained in the wound dressing has broad antimicrobial activity, including against MRSA and VRE. Antimicrobial action (>3 log steps) associated with the ionic silver from the silver alginate fibres (1.5%) is observed in vitro after just 24 h and this remains stable for up to seven days<br>|
| infected wounds<br>Ideally 28 patients with infected wounds (TILI Score ≥ 5) to be included. | Device: Suprasorb® A + Ag wound dressing and rope<br>* Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressings / Packing Rope are soft, conformable wound coverings with a high mannuronic acid content (mass per unit area ≥100 g/m2). The silver impregnated calcium alginate fibres react with wound exudate or blood to form a gel which creates a moist wound environment. The silver contained in the wound dressing has broad antimicrobial activity, including against MRSA and VRE. Antimicrobial action (>3 log steps) associated with the ionic silver from the silver alginate fibres (1.5%) is observed in vitro after just 24 h and this remains stable for up to seven days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint | Change of local wound infection after 21 days of treatment with Suprasorb® A+Ag in wounds at risk of infection and infected wounds, assessed by Therapeutical Index for Local Infections (TILI) score. The investigator will evaluate six indirect parameters of the local wound infection: erythema to surrounding skin heat oedema, induration or swelling spontaneous pain or pressure pain stalled wound healing increase and/or change in colour or smell of exudate Each present parameter will be assigned 1 point. All points will be summed up and the final score (min 0, max 6) will define the local infection status. In case the score is ≥ 5, wound is deemed to be locally infected. | 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device-related adverse events (device safety) | Frequency and character severity of device deficiencies (DDs), adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs) and incidents. | 20 months | 
| Change of wound bed condition, defined by the combination of the following parameters: | Wound shift (reduction change of distribution of necrotic, fibrin and granulation tissue in % of the wound area), measured by W.H.A.T. (Wound Healing Analyzing Tool) Wound shift (change of distribution of necrotic, fibrin and granulation tissue in % of the wound area), assessed visually by the investigators Change in grade of exudation (from very high to none) Change in type of exudate (from purulent to clear) Change of peri-wound skin condition (presence or absence of erosion, maceration, dryness /scaling, edema, redness) Wound size reduction over time measured by W.H.A.T. (Wound Healing Analyzing Tool) Achieved healing rate, measured as a proportion of patients having complete wound epithelization after 20 months of treatment to the whole study population | 20 months | 
| Change in wound-related pain, with a separate assessment of: | pain by dressing removal measured by NRS (numeric-rating scale from 0 to 10, where 0=no pain, 10=worst pain imaginable) change in general wound related pain, measured by NRS (numeric-rating scale from 0 to 10, where 0=no pain, 10=worst pain imaginable) | 20 months | 
| Change in wound-related quality of life | Change in wound-related quality of life, measured by Wound QoL Questionnaire | 20 months | 
| User satisfaction | User satisfaction, assessed by the questionnaire | 20 months | 
| Mean frequency of dressing changes | Mean frequency of dressing changes | 20 months | 
| Mean time of treatment | Mean time of treatment | 20 months |