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

Lohmann & Rauscher (L&R)

Status: Completed

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

Treatments: Device: Suprasorb® A + Ag wound dressing and rope

Study type: Observational

Funder types: Industry

Identifiers

NCT05646121

2021-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

99 participants in 2 patient groups

wounds at risk of infection

Description:

Ideally 71 patients with wounds at risk of infection (W.A.R. Score ≥ 3) to be included.

Treatment:

Device: Suprasorb® A + Ag wound dressing and rope

infected wounds

Description:

Ideally 28 patients with infected wounds (TILI Score ≥ 5) to be included.

Treatment:

Device: Suprasorb® A + Ag wound dressing and rope