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.
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.
Study Type
OBSERVATIONAL
Enrollment
99
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
Private Practice
Bolesławiec, Poland
Private Practice
Krakow, Poland
Private Practice
Lodz, Poland
Private Practice
Ostróda, Poland
Private Practice
Oświęcim, Poland
Private Practice
Pabianice, Poland
Private Practice
Swidnica, Poland
Private Practice
Wroclaw, Poland
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.
Time frame: 20 months
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.
Time frame: 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
Time frame: 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)
Time frame: 20 months
Change in wound-related quality of life
Change in wound-related quality of life, measured by Wound QoL Questionnaire
Time frame: 20 months
User satisfaction
User satisfaction, assessed by the questionnaire
Time frame: 20 months
Mean frequency of dressing changes
Mean frequency of dressing changes
Time frame: 20 months
Mean time of treatment
Mean time of treatment
Time frame: 20 months
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