Clinical trial NCT05646121: Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcer
Arterial Ulcers
Venous Leg Ulcer
Diabetic Ulcers
Surgical Wound
Skin Graft
Lead sponsor: Lohmann & Rauscher
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The main target population of this investigation are older people. Patients will be enrolled with wounds at risk of infection and infected wounds which are: heavily exuding, superficial or deep, for:

* pressure ulcers
* arterial ulcers
* venous lower leg ulcers
* diabetic ulcers
* post-operative wounds
* skin graft and donor sites.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined endpoint
timeFrame: 20 months
Secondary outcomes:
measure: Rate of device-related adverse events (device safety)
timeFrame: 20 months
measure: Change of wound bed condition, defined by the combination of the following parameters:
timeFrame: 20 months
measure: Change in wound-related pain, with a separate assessment of:
timeFrame: 20 months
measure: Change in wound-related quality of life
timeFrame: 20 months
measure: User satisfaction
timeFrame: 20 months
measure: Mean frequency of dressing changes
timeFrame: 20 months
measure: Mean time of treatment
timeFrame: 20 months
Other outcomes:
Locations:
city: Bolesławiec
country: Poland
facility: Private Practice
city: Kraków
country: Poland
facility: Private Practice
city: Ostróda
country: Poland
facility: Private Practice
city: Oświęcim
country: Poland
facility: Private Practice
city: Pabianice
country: Poland
facility: Private Practice
city: Wrocław
country: Poland
facility: Private Practice
city: Łódź,
country: Poland
facility: Private Practice
city: Świdnica
country: Poland
facility: Private Practice
Study officials:
affiliation: Lohmann & Rauscher
name: Claudia Feldkamp, Dr.
role: STUDY_DIRECTOR
References: