- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409759
Perforator Based Interposition Plasty
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9728 NZ
- Martini Hospital, Burns centre
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Noord-Holland
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Beverwijk, Noord-Holland, Netherlands, 1942 LE
- Red Cross Hospital
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Zuid-Holland
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Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
- Maastad hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perforator based interposion flap
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.
|
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.
|
Other: Full thickness graft
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expansion/contraction of the interpositioned skin after 3 months
Time Frame: 3 months
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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?
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paul P M Van Zuijlen, Prof, Red Cross Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10104 and 10110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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