Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds

Lohmann & Rauscher104 enrolled

Overview

The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.

This clinical investigation will be conducted as multicenter, randomized in parallel groups, non-inferiority controlled trial. After randomization patients will receive wound debrided with the investigational device or the comparator device during one study visit. During the study visit patients will have clinical examination and wound photos will be taken.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Diabetic Ulcers Arterial Ulcers Venous Ulcers Pressure Ulcers

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Patient is legally capable * Patient has signed written informed consent * Presence of one of the following wounds * Venous lower leg ulcer * Arterial ulcer * Diabetic ulcer * Pressure ulcer * Post-operative wound healing by secondary intention * Traumatic wound * Surgical wound * Burn or scald (grade III: after surgical debridement) * Epidermolysis Bullosa * Wound area \>4cm2 * The entire wound area can be displayed on one photo from a distance of 25-30 cm * Covered with at least 30% debris, necrosis, slough, fibrotic tissue Exclusion Criteria: * Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components * Pregnancy or breast feeding * Patient is illiterate * Participation in a interventional clinical trial within the last 14 days and during participation in this study * Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results * severe pain or hyperesthesia in the wound area * history of drug or alcohol abuse * chronic analgesic use (especially opioids) that could influence baseline pain perception * cognitive impairment, which may affect the ability to accurately self-report pain * Use of anaesthesia before the debridment procedure * presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary

Locations (5)

MelissaMed Poradnia

Lodz, Poland

RECRUITING

MIKOMED Sp. z.o.o.

Lodz, Poland

RECRUITING

NZOZ Neuromed M. i M. Nastaj

Lublin, Poland

RECRUITING

Specjalistyczny Osrodek Leczniczo Badawczy

Ostróda, Poland

RECRUITING

Lecran - Centrum Opieki Nad Ranami-Kunickiego

Wroclaw, Poland

RECRUITING

Outcomes

Primary Outcomes

Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T.

Wound photos will be taken. On these photos, the amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by W.H.A.T. (Wound Healing Analyzing Tool).

Time frame: 1 day

Secondary Outcomes

Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator

The amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by the investigator.

Time frame: 1 day

Rate of device-related adverse events (device safety)

Frequency and character of device deficiencies (DDs), adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs) and incidents.

Time frame: 1 day

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

* Change in grade of exudate (from very high to none) * Change in type of exudate (from haemorrhagic to serous) * Change of the wound surrounding skin (presence or abscence of normal, erosive, dry/scaling, dry cracking, oeadematous, red or discoloured skin and cream residues) * Change of the wound bed and wound edges (presence or abscence of debris, discoloration, maceration, hyperkeratosis, smooth skin, thickened/rolled edges, undermining, vital tissue, biofilm) * Removal of biofilm (estimated by the user)

Time frame: 1 day

Wound related pain

Wound related pain will be measured directly before, during and 10 +/-2 minutes using NRS-11 scale

Time frame: 1 day

Time needed for debridement

Time needed for the debridement procedure will be assessed using a stopper

Time frame: 1 day

Amount of products

Amount of products that were used during one debridement session will be assessed.

Time frame: 1 day

Patient satisfaction

Patient satisfaction with the treatment procedure on a scale from 1-5

Time frame: 1 day

User satisfaction

User satisfaction assessed via a questionnaire

Time frame: 1 day

Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts