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

Lohmann & Rauscher (L&R)

Status: Enrolling

Conditions: Burns and Scalds; Surgical Wounds; Postoperative Wounds Healing by Secondary Intention; Epidermolysis Bullosa (EB); Venous Ulcers; Arterial Ulcers; Diabetic Ulcers; Traumatic Wounds; Pressure Ulcers

Treatments: Device: two sided debridement pad; Device: one sided debridment pad

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07312513

2024-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Debrisoft Duo

Experimental group

Description:

Patients will be treated with the investigational device which is a two sided pad for the debridement of a wide range of wounds. The soft, wide side of the device is identical to the comparator device. The textured, beige side is unique to the investigational device and makes it easy to loosen strongly adherent, fibrinous wound debris.

Treatment:

Device: two sided debridement pad

Debrisoft Pad

Active Comparator group

Description:

Patients will be treated with the comparator device which is a one sided pad for the debridement of a wide range of wounds. The device has the same soft, wide side as the investigational product but does not have the aditional textured, beige side.

Treatment:

Device: one sided debridment pad