BurnsPhase 3VAC-MNCT00548314
Dermal Substitute and Topical Negative Pressure in Burns
A Phase 3 study testing dermal matrix, Split skin graft and VAC therapy (KCI) in people with Burns, run by Association of Dutch Burn Centres at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- dermal matrix, Split skin graft and VAC therapy (KCI)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2007to Feb 2011
- Phase
- Phase 3
- 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
- Patients >=18 yrs with acute burns/trauma wounds that require skin grafting
- Minimal study wound surface 10 cm2
- Maximal study wound surface 300 cm2
- Maximal TBSA 15% full thickness wounds
- Informed consent
Who cannot join
- Patients with wounds without adequate possibility to apply VAC
- Immunocompromised patients
- Infected wounds
- Pregnant patients
- Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders (e.g. borderline or depression).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds
The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months.
Additionally, an increase of the take of graft and improvement of scar assessment scale, scar colour/pigmentation and time to complete wound closure, is expected.
Read the detailed description
The standard therapy for full thickness wounds is transplantation with a split thickness skin graft. However, scars usually develop as a result of this therapy. Previous research has demonstrated an improvement of scar quality if a dermal substitute was applied in combination with a split skin graft in reconstructive wounds, but not so much in burn wounds. One of the problems in burn wounds was the retarded outgrowth of the skin graft when a dermal substitute was applied in a one step procedure with the graft. Since then, application of topical negative pressure has demonstrated that the take and outgrowth of a skin graft can be improved by this technique. It now seems feasible to combine these two technologies in order to improve the quality of healing of burn wounds in the acute phase of healing.
Aim of the study is to investigate if application of a dermal substitute in combination with topical negative pressure can improve the quality of the scar in burn wounds.
- Conditions
- Burns
- Being tested
- dermal matrix, Split skin graft, VAC therapy (KCI)
- Keywords
- Matriderm, Dermal matrix, VAC therapy, Split skin graft, Burns, Scar quality
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dermal matrixOther
Also called Matriderm
1mm thickness matrix composed of collagen-elastin hydrolosate
Split skin graftProcedure or surgery
VAC therapy (KCI)Device
VAC therapy for 3-5 days 125mmHg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days. Receives: Other: dermal matrix; Device: VAC therapy (KCI) |
| 2 | Experimental | After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5. Receives: Other: dermal matrix |
| 3 | Experimental | After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days. Receives: Device: VAC therapy (KCI) |
| 4 | Active comparator | After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5. Receives: Procedure: Split skin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin elasticity parameters (representing scar quality)
Measured: after 3 months
Secondary outcomes (1)
take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer)
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association of Dutch Burn Centres
- Sponsor type
- University, hospital or other
- Investigators
- Esther Middelkoop, Professor, Study director, Association of Dutch Burn Centres (ADBC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548314
- Sponsor's protocol ID
- 07.109
- Acronym
- VAC-M
- Status last verified
- Mar 2011
- First submitted
- 22 Oct 2007
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds
- ClinicalTrials.gov ID
- NCT00548314
- Acronym / sponsor ID
- VAC-M / 07.109
- Conditions
- Burns
- Keywords
- Matriderm, Dermal matrix, VAC therapy, Split skin graft, Burns, Scar quality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Association of Dutch Burn CentresUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Oct 2007 (estimated)
- 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.
The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months.
Additionally, an increase of the take of graft and improvement of scar assessment scale, scar colour/pigmentation and time to complete wound closure, is expected.
Detailed description
The standard therapy for full thickness wounds is transplantation with a split thickness skin graft. However, scars usually develop as a result of this therapy. Previous research has demonstrated an improvement of scar quality if a dermal substitute was applied in combination with a split skin graft in reconstructive wounds, but not so much in burn wounds. One of the problems in burn wounds was the retarded outgrowth of the skin graft when a dermal substitute was applied in a one step procedure with the graft. Since then, application of topical negative pressure has demonstrated that the take and outgrowth of a skin graft can be improved by this technique. It now seems feasible to combine these two technologies in order to improve the quality of healing of burn wounds in the acute phase of healing.
Aim of the study is to investigate if application of a dermal substitute in combination with topical negative pressure can improve the quality of the scar in burn wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: dermal matrix, Device: VAC therapy (KCI)After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days. |
| 2 | Experimental | Other: dermal matrixAfter excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5. |
| 3 | Experimental | Device: VAC therapy (KCI)After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days. |
| 4 | Active comparator | Procedure: Split skin graftAfter excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients >=18 yrs with acute burns/trauma wounds that require skin grafting
- Minimal study wound surface 10 cm2
- Maximal study wound surface 300 cm2
- Maximal TBSA 15% full thickness wounds
- Informed consent
Key exclusion criteria (5 listed)
- Patients with wounds without adequate possibility to apply VAC
- Immunocompromised patients
- Infected wounds
- Pregnant patients
- Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders (e.g. borderline or depression).
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 |
|---|---|---|
| dermal matrixAlso: Matriderm1mm thickness matrix composed of collagen-elastin hydrolosate | Other | 1, 2 |
| Split skin graft | Procedure or surgery | 4 |
| VAC therapy (KCI)VAC therapy for 3-5 days 125mmHg | Device | 1, 3 |
Primary outcome
skin elasticity parameters (representing scar quality)
Time frame: after 3 months
1 secondary outcome
take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer)
Time frame: after 3 months
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 24 Mar 2011.
Related trials for Burns
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
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.
Esther Middelkoop, Professor study director
Association of Dutch Burn Centres (ADBC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dermal matrix, Split skin graft and VAC therapy (KCI) in people with Burns, run by Association of Dutch Burn Centres at 1 site in Netherlands.
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 5 inclusion and 5 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 24 Mar 2011. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
skin elasticity parameters (representing scar quality) (time frame: after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2011.