CompletedNot Applicable

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

Poland99 participantsStarted 2022-09-13

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 compli…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Combined endpoint

Timeframe: 20 months

Trial details

NCT IDNCT05646121

SponsorLohmann & Rauscher

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-05

View on ClinicalTrials.gov More Pressure Ulcer trials