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

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

Interventions

DEVICE

Debridement with Debritom+ micro water jet 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)

OTHER

Debridement with

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)

Sponsors & Collaborators

• School of Health Sciences Geneva

  lead OTHER

Principal Investigators

• Sebastian E Probst, Prof Dr · HES-SO University of Applied Sciences and Arts Western Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2023-05-31

Completion

2023-06-15

Countries

• Switzerland

Study Locations