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

NCT05646121 | Completed

• 1 other identifier: 2021-02
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of device-related adverse events (device safety)

  20 months

• Change of wound bed condition, defined by the combination of the following parameters:

  20 months

• Change in wound-related pain, with a separate assessment of:

  20 months

• Change in wound-related quality of life

  20 months

• User satisfaction

  20 months

Study Arms (2)

wounds at risk of infection

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

infected wounds

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

Device: Suprasorb® A + Ag wound dressing and rope

Interventions

Suprasorb® A + Ag wound dressing and rope DEVICE

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

infected wounds; wounds at risk of infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lohmann & Rauscher: lead

Study Sites (8)

Private Practice

Bolesławiec, Poland

Location

Private Practice

Krakow, Poland

Location

Private Practice

Lodz, Poland

Location

Private Practice

Ostróda, Poland

Location

Private Practice

Oświęcim, Poland

Location

Private Practice

Pabianice, Poland

Location

Private Practice

Swidnica, Poland

Location

Private Practice

Wroclaw, Poland

Location

MeSH Terms

Conditions

Pressure Ulcer; Varicose Ulcer; Surgical Wound

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Wounds and Injuries

Study Officials

• Claudia Feldkamp, Dr.

  Lohmann & Rauscher

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: December 12, 2022
• Study Start: September 13, 2022
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (8)