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Wound HealDebritomNCT04514783

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

A study testing Debridement with Debritom+ micro water jet device and Debridement with in people with Wound Heal and Chronic Wound, run by School of Health Sciences Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Wound Heal, Chronic Wound
What is being tested?
Debridement with Debritom+ micro water jet device and Debridement with
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2022to 15 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Cité Génération Maison de santé

    Onex, Canton of Geneva, 1213

Other trials in Switzerland

About this study

Official title: Healthy Tissue Preservation During Wound Debridement by Using Debritom+ Micro Water Jet Technology - a Pilot Study

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.

Read the detailed description

Chronic wounds (CWs) 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. A wound becomes chronic when they fail to progress through a timely sequence of repair resulting in anatomic and functional integrity within a period of approximatively three months. CWs affect a large segment of the world population (3) with a prevalence of mixed aetiologies of 2.21 per 1000. The annual costs of care of patients with CWs is estimated to be £6 billion for 2.2 million in the United Kingdom (UK).

In CWs a massive production of matrix molecules resulting from underlying cellular dysfunction and dysregulation can be found. Fibrinogen and fibrin are also common in chronic wounds and it is thought that these and other macromolecules scavenge growth factors and other molecules involved in promoting wound repair. Chronic wound fluid is also biochemically distinct from acute wound fluid; it slows down, and can block the proliferation of cells, which are essential for the wound healing process. The therapeutic approach to enhance the wound healing process include wound bed preparation or wound dressing management. Wound bed preparation as a concept allows the clinician to focus systematically on all of the critical components of a non-healing wound to identify the cause of the problem, and implement a care programme so as to achieve a stable wound that has healthy granulation tissue and a well vascularised wound bed. 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 (8). Debridement is defined as the removal of foreign material and necrotic tissue from a wound and it can also help to stimulate wound healing (8). 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. Autolytic, chemical, and surgical methods are considered to be selective techniques, whereas mechanical methods are considered to be nonselective. Selective modalities remove mainly necrotic tissue, whereas nonselective modalities remove both necrotic and viable tissue. In practice, selective modalities can also remove or damage healthy tissue. The most selective modalities are autolytic and biologic techniques. Instrument debridement is the most used debridement method from many years. It has been shown to improve wound healing and its main advantages are the low cost of treatment and the speed of dead tissue removal. This method is done with the intention of removing small amounts of visible devitalized tissue. However, residual nonviable tissue may remain at the microscopic level resulting in slowing healing process. On the contrary, the risk of exaggerated / mismanaged excision is not non-existent and can lead to damage to healthy tissue or even damage to deeper structures (blood vessels, nerves, tendons or even bones), resulting in delayed healing too. Instrument debridement can be painful. Patient's fear about this approach is a reality that can also be problematic. Autolytic or enzymatic debridement, which are more selective and less prone to patient's reluctance could remediate to this situation. However, time for complete dead tissue removal is considerably increased, requiring multiple applications and stringent patient compliance. While this type of debridement does not damage healthy tissue and causes little or no pain, it can cause contact sensitization. Water-jet debridement systems seems to pose a valid alternative to other methods. The approach is based on mechanical and homogenous wound cleansing and stimulation by a micro-jet of water. It uses an ultra-fine, powerful and adjustable micro-jet of water that precisely removes soft to fibrous deposits from the wound. It is usually fast. Softness of the treatment depends on the speed and intensity of the water jet according to wound condition. Adequate pain control should be performed and surface anaesthesia may be required. Water jet debridement promotes natural wound healing by inducing micro-bleeding from the wound bed and minimizes scarring. While there is ample anecdotal evidence about the efficacy of such method to preserve healthy tissue, the investigators propose here to document this ability by measuring precisely wound depth before and after debridement using Debritom+ micro water jet technology. The investigators propose to systematically assess patient's apprehension regarding this technique too.

Being tested
Debridement with Debritom+ micro water jet device, Debridement with
Keywords
debridement, wound care, wound bed preparation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Debridement with Debritom+ micro water jet deviceDevice

    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)
  • Debridement withOther

    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)
Study groups in NCT04514783
Study groupRoleWhat they receive
Group 2OtherUse of scalpel and a spoon-shaped metal instrument (curette).
Receives: Other: Debridement with
Group 1ExperimentalUse of Debritom+ micro water jet technology
Receives: Device: Debridement with Debritom+ micro water jet device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start1 Jan 2022
  3. Primary completion31 May 2023
  4. Study completion15 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04514783
Sponsor's protocol ID
Debridment
Acronym
Debritom
Status last verified
Jun 2023
First submitted
13 Aug 2020
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: data will be anonymised

Publications

  • Probst S, Saini C. Microjet wound therapy versus sharp debridement on wound size reduction: a pilot randomised controlled trial. J Wound Care. 2024 May 2;33(5):357-364. doi: 10.12968/jowc.2024.33.5.357.

    PubMed 38683777

Questions about this trial

What is this clinical trial studying?

A study testing Debridement with Debritom+ micro water jet device and Debridement with in people with Wound Heal and Chronic Wound, run by School of Health Sciences Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in wound depth (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04514783, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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