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.
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
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.
- Conditions
- Wound Heal, Chronic Wound
- 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 group | Role | What they receive |
|---|---|---|
| Group 2 | Other | Use of scalpel and a spoon-shaped metal instrument (curette). Receives: Other: Debridement with |
| Group 1 | Experimental | Use 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.
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.
- First posted17 Aug 2020
- Study start1 Jan 2022
- Primary completion31 May 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian E Probst, Prof Dr, Study chair, HES-SO University of Applied Sciences and Arts Western Switzerland
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Tissue Preservation During Wound Debridement by Using Debritom+ Micro Water Jet Technology - a Pilot Study
- ClinicalTrials.gov ID
- NCT04514783
- Acronym / sponsor ID
- Debritom / Debridment
- Conditions
- Wound Heal, Chronic Wound
- Keywords
- debridement, wound care, wound bed preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Other | Other: Debridement withUse of scalpel and a spoon-shaped metal instrument (curette). |
| Group 1 | Experimental | Device: Debridement with Debritom+ micro water jet deviceUse of Debritom+ micro water jet technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- An existing chronic wound requiring debridement
- Age over 18 years
- Proficiency in the French language
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debridement with Debritom+ micro water jet deviceVisits 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) | Device | Group 1 |
| Debridement withVisits 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) | Other | Group 2 |
Primary outcome
change in wound depth
Time frame: 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 38683777Probst 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.
- Individual participant dataSharing planned: No. data will be anonymised
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian E Probst, Prof Dr study chair
HES-SO University of Applied Sciences and Arts Western Switzerland
1 site in 1 country: see every site and its status.
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.