Healthy Tissue Preservation During Wound Debridement by Using Debritom+ Micro Water Jet Technology

NCT04514783 | Completed DMC

• 1 other identifier: Debridment
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic wounds are common and carry out an important and often neglected burden not only to the individual, the family but also to the society as a whole. The therapeutic approach to the management of chronic wounds include wound bed preparation or wound dressing management. Wound bed preparation is a concept emphasizing a holistic and systematic approach to evaluate and remove barriers to the healing process to allow the wound healing process to progress normally. Debridement is an integrated part of wound bed preparation, achieving certain goals and, thus, creating a healthy wound bed, margins and peri-wound skin with the objective to promote and accelerate healing. Debridement is defined as the removal of foreign material and necrotic tissue from a wound and it can also help to stimulate wound healing. However, not all methods of debridement are the same. Each method has advantages and disadvantages that must be clearly understood. In the present clinical practice, there are several methods of wound debridement: autolytic, enzymatic, mechanical, surgical (sharp) and biologic. The most common method is the mechanical debridement. Currently a micro-water jet technique was introduced into clinical practice. The micro-water jet technique Debritom+ is an effective alternative to traditional instrument interventions performed with the scalpel and/or curette. A sterile liquid is expelled from a nozzle at a selected intensity and accurately sprayed onto the wound surface. The desired effect is the generation of targeted micro-bleedings to stimulate regeneration and healing processes while preserving the underlying healthy tissue. Today, there is no clinical evidence quantitatively comparing one debridement method over the other. Therefore the invesitgators propose a pilot study to measure the extent of tissue loss after debridement using Debritom+ micro-water jet technology versus traditional instrument debridement procedure using scalpel and curette.

Conditions

Wound Heal; Chronic Wound

Keywords

debridement; wound care; wound bed preparation

Outcome Measures

Primary Outcomes (1)

• change in wound depth

  to determine the invasiveness of each debridement technique by the measures of wound dimensions (length, width, depth, area and volume) using Woundworks® device before and after debridement over a 6 weeks treatment period.

  6 weeks

Study Arms (2)

Group 2

OTHER

Use of scalpel and a spoon-shaped metal instrument (curette).

Other: Debridement with

Group 1

EXPERIMENTAL

Use of Debritom+ micro water jet technology

Device: Debridement with Debritom+ micro water jet device

Interventions

Debridement with Debritom+ micro water jet device DEVICE

Visits to the outpatient wound-care center as directed by a physician. Wound care performed by the study nurse according to the study-protocol. Each necessary wound debridement will be the same and will be as follows: * Removal of old dressing * Woundworks® 3D imaging * Applying analgesic if necessary * Applying a soaked gaze with Sodium chloride (NaCl) 0.9% solution on the wound (5 minutes) * Debridement using Debritom+ micro water jet technology * Wound cleansing with NaCl 0.9% solution * Woundworks® 3D imaging * Application of new dressing (according to the wound healing phases, medical prescription) In the case debridement is no more required, wound dressing change will be performed as follows: * Removal of old dressing * Woundworks® 3D imaging * Wound cleansing with NaCl 0.9% solution * Application of new dressing (according to the wound healing phases, medical prescription)

Group 1

Debridement with OTHER

Visits to the outpatient wound-care center as directed by a physician. Wound care performed by the respective study nurse according to the study-protocol. Each necessary wound debridement will be the same and will be as follows: * Removal of old dressing * Woundworks® 3D imaging * Applying analgesic if necessary * Applying a soaked gaze with NaCl 0.9% solution on the wound (5 minutes) * Debridement using scalpel and curette * Wound cleansing with NaCl 0.9% solution * Woundworks® 3D imaging * Application of new dressing (according to the wound healing phases, medical prescription) In the case debridement is no more required, wound dressing change will be performed as follows: * Removal of old dressing * Woundworks® 3D imaging * Wound cleansing with NaCl 0.9% solution * Application of new dressing (according to the wound healing phases, medical prescription)

Group 2

Eligibility Criteria

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

You may qualify if:

• An existing chronic wound requiring debridement
• Age over 18 years
• Proficiency in the French language

You may not qualify if:

• Valid informed consent is not or cannot be given
• Patients with wound presenting a dry necrosis
• Arterial insufficiency stage III or IV
• Patients under double anti-aggregation treatment

Sponsors & Collaborators

• School of Health Sciences Geneva: lead

Study Sites (1)

Cité Génération Maison de santé

Onex, Canton of Geneva, 1213, Switzerland

Location

MeSH Terms

Interventions

Debridement

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Sebastian E Probst, Prof Dr

  HES-SO University of Applied Sciences and Arts Western Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: January 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 15, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)