Burn Scar ContractionPhase 2NCT01409759
Perforator Based Interposition Plasty
A Phase 2 study testing Perforator based interposition flap in people with Burn Scar Contraction, run by Association of Dutch Burn Centres at 3 sites in Netherlands.
Trial summary
Objective: to evaluate the perforator based interposition plasty in comparison to the standard technique (full thickness graft) for scar contracture releases. Study design: A randomised controlled multicentre intervention study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn Scar Contraction
- What is being tested?
- Perforator based interposition flap
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jul 2011to Nov 2013
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication for release of burn scar contracture
- Sufficient tissue for a perforator- based interposition flap (preferably normal skin)
- Able to give informed consent
Who cannot join
- Age < 18 years
- Location: scars on the face and scalp
- Smoking (however, the patient is eligible if smoking is quit > 3 weeks before the operation)
- Psychiatric disorders (if a loss to follow-up is anticipated)
- Language barrier
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Red Cross Hospital
Beverwijk, North Holland, 1942 LE
Martini Hospital, Burns centre
Groningen, 9728 NZ
Maastad Hospital
Rotterdam, South Holland, 3079 DZ
About this study
Official title: Perforator Based Interposition Flaps for Sustainable Release of Burn Scar Contracture: a Reliable, Simple and Versatile Technique. A Randomised Controlled Trial.
Objective: to evaluate the perforator based interposition plasty in comparison to the standard technique (full thickness graft) for scar contracture releases.
Study design: A randomised controlled multicentre intervention study.
Read more
Study population: Patients, aged 18 years and older, who require surgery for release of a scar contracture, are eligible for this study. In total 50 patients will be recruited with a follow-up of 3 months post-operatively.
Intervention: A release of the contracture will be performed in combination with òr the standard technique (full thickness graft) òr the perforator based interposition plasty.
Main study parameters/endpoints: the main study parameter is the amount of contraction of the flap/graft after three months.
Read the detailed description
Rationale:
Scar contracture remains a considerable problem for the burned patient. The standard method of treatment is contracture release in combination with the application of a full or split thickness graft to close the defect. Unfortunately, the effectiveness of skin grafts is limited by scar contraction, which often necessitates additional reconstructions. Moreover, parts of the skin graft may be lost due to poor revascularisation or infection.
Since the discovery of perforator vessels, many types of new flaps can be harvested as long as it incorporates a perforator bundle (artery and vein). This flap design based on perforator vessels and local available skin, should lead to an increased flap survival and superior functional outcome. Based on this concept we developed and explored the possibility of an algorithm for treatment by means of a pilot study performed on 22 patients with a scar contracture. Results show a survival of all flaps of 100% and an expansion of the surface area by 16% after a follow up of at least 3 months. However the implications of the use of perforator based flaps for burn surgery by means of a RCT has yet to be determined.
Primary objective:
Is interpositioned skin of superior quality, as represented by less contraction with the use of the perforator based interposition flaps, compared to the gold standard (full thickness grafts), after 3 months, as measured by transparent sheet planimetry?
Secondary objectives:
- Survival of the flap/graft: i.e. measured by the amount of necrosis
- The quality of the scar: elasticity, colour, subjective scar evaluation
Inclusion criteria are:
- Indication for release of burn scar contracture
- Sufficient tissue for a perforator- based interposition flap (preferably normal skin)
- Able to give informed consent
Exclusion criteria are:
- Age < 18 years
- Location: scars on the face and scalp
- Smoking (however, the patient is eligible if smoking is quit > 3 weeks before the operation)
- Psychiatric disorders (if a loss to follow-up is anticipated)
- Language barrier
- Conditions
- Burn Scar Contraction
- Being tested
- Perforator based interposition flap
- Keywords
- Perforators, Interposition plasty, Contracture release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perforator based interposition flapProcedure or surgery
The flap is designed based on a selected perforator and locally available, preferably normal skin adjacent to the burn scar contracture. The flap consists of skin and underlying subcutaneous tissue. Based on the pre-operative defined perforator, the required length and width and the available preferable normal skin, a design for the perforator flap is made.
| Study group | Role | What they receive |
|---|---|---|
| Perforator based interposion flap | Experimental | In our concept the flap is designed based on a selected perforator and locally available, preferably normal skin adjacent to the burn scar contracture. The flap consists of skin and underlying subcutaneous tissue. Based on the pre-operative defined perforator, the required length and width and the available preferable normal skin, a design for the perforator flap is made. Receives: Procedure: Perforator based interposition flap |
| Full thickness graft | Other | Not described Receives: Procedure: Perforator based interposition flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expansion/contraction of the interpositioned skin after 3 months
Is interpositioned skin of superior quality, as represented by less contraction with the use of the perforator based interposition flaps, compared to the gold standard (full thickness grafts), after 3 months, as measured by transparent sheet planimetry?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Scar ContractionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association of Dutch Burn Centres
- Sponsor type
- University, hospital or other
- Investigators
- Paul P M Van Zuijlen, Prof, Principal investigator, Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409759
- Sponsor's protocol ID
- 10104 and 10110
- Status last verified
- Jun 2015
- First submitted
- 3 Aug 2011
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perforator Based Interposition Flaps for Sustainable Release of Burn Scar Contracture: a Reliable, Simple and Versatile Technique. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01409759
- Acronym / sponsor ID
- 10104 and 10110
- Conditions
- Burn Scar Contraction
- Keywords
- Perforators, Interposition plasty, Contracture release
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Association of Dutch Burn CentresUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Aug 2011 (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.
Objective: to evaluate the perforator based interposition plasty in comparison to the standard technique (full thickness graft) for scar contracture releases.
Study design: A randomised controlled multicentre intervention study.
Study population: Patients, aged 18 years and older, who require surgery for release of a scar contracture, are eligible for this study. In total 50 patients will be recruited with a follow-up of 3 months post-operatively.
Intervention: A release of the contracture will be performed in combination with òr the standard technique (full thickness graft) òr the perforator based interposition plasty.
Main study parameters/endpoints: the main study parameter is the amount of contraction of the flap/graft after three months.
Detailed description
Rationale:
Scar contracture remains a considerable problem for the burned patient. The standard method of treatment is contracture release in combination with the application of a full or split thickness graft to close the defect. Unfortunately, the effectiveness of skin grafts is limited by scar contraction, which often necessitates additional reconstructions. Moreover, parts of the skin graft may be lost due to poor revascularisation or infection.
Since the discovery of perforator vessels, many types of new flaps can be harvested as long as it incorporates a perforator bundle (artery and vein). This flap design based on perforator vessels and local available skin, should lead to an increased flap survival and superior functional outcome. Based on this concept we developed and explored the possibility of an algorithm for treatment by means of a pilot study performed on 22 patients with a scar contracture. Results show a survival of all flaps of 100% and an expansion of the surface area by 16% after a follow up of at least 3 months. However the implications of the use of perforator based flaps for burn surgery by means of a RCT has yet to be determined.
Primary objective:
Is interpositioned skin of superior quality, as represented by less contraction with the use of the perforator based interposition flaps, compared to the gold standard (full thickness grafts), after 3 months, as measured by transparent sheet planimetry?
Secondary objectives:
- Survival of the flap/graft: i.e. measured by the amount of necrosis
- The quality of the scar: elasticity, colour, subjective scar evaluation
Inclusion criteria are:
- Indication for release of burn scar contracture
- Sufficient tissue for a perforator- based interposition flap (preferably normal skin)
- Able to give informed consent
Exclusion criteria are:
- Age < 18 years
- Location: scars on the face and scalp
- Smoking (however, the patient is eligible if smoking is quit > 3 weeks before the operation)
- Psychiatric disorders (if a loss to follow-up is anticipated)
- Language barrier
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perforator based interposion flap | Experimental | Procedure: Perforator based interposition flapIn our concept the flap is designed based on a selected perforator and locally available, preferably normal skin adjacent to the burn scar contracture. The flap consists of skin and underlying subcutaneous tissue. Based on the pre-operative defined perforator, the required length and width and the available preferable normal skin, a design for the perforator flap is made. |
| Full thickness graft | Other | Procedure: Perforator based interposition flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for release of burn scar contracture
- Sufficient tissue for a perforator- based interposition flap (preferably normal skin)
- Able to give informed consent
Key exclusion criteria (5 listed)
- Age < 18 years
- Location: scars on the face and scalp
- Smoking (however, the patient is eligible if smoking is quit > 3 weeks before the operation)
- Psychiatric disorders (if a loss to follow-up is anticipated)
- Language barrier
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 |
|---|---|---|
| Perforator based interposition flapThe flap is designed based on a selected perforator and locally available, preferably normal skin adjacent to the burn scar contracture. The flap consists of skin and underlying subcutaneous tissue. Based on the pre-operative defined perforator, the required length and width and the available preferable normal skin, a design for the perforator flap is made. | Procedure or surgery | Full thickness graft, Perforator based interposion flap |
Primary outcome
Expansion/contraction of the interpositioned skin after 3 months
Time frame: 3 months
Is interpositioned skin of superior quality, as represented by less contraction with the use of the perforator based interposition flaps, compared to the gold standard (full thickness grafts), after 3 months, as measured by transparent sheet planimetry?
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 26 Jun 2015.
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.
Paul P M Van Zuijlen, Prof principal investigator
Red Cross Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perforator based interposition flap in people with Burn Scar Contraction, run by Association of Dutch Burn Centres at 3 sites 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 3 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 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Expansion/contraction of the interpositioned skin after 3 months (time frame: 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 26 Jun 2015.