Perforator Based Interposition Plasty
Primary Purpose
Burn Scar Contraction
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Perforator based interposition flap
Sponsored by
About this trial
This is an interventional treatment trial for Burn Scar Contraction focused on measuring Perforators, Interposition plasty, Contracture release
Eligibility Criteria
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
Sites / Locations
- Red Cross Hospital
- Maastad Hospital
- Martini Hospital, Burns centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Perforator based interposion flap
Full thickness graft
Arm Description
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.
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
Full Information
NCT ID
NCT01409759
First Posted
August 3, 2011
Last Updated
June 25, 2015
Sponsor
Association of Dutch Burn Centres
1. Study Identification
Unique Protocol Identification Number
NCT01409759
Brief Title
Perforator Based Interposition Plasty
Official Title
Perforator Based Interposition Flaps for Sustainable Release of Burn Scar Contracture: a Reliable, Simple and Versatile Technique. A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Association of Dutch Burn Centres
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar Contraction
Keywords
Perforators, Interposition plasty, Contracture release
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perforator based interposion flap
Arm Type
Experimental
Arm Description
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.
Arm Title
Full thickness graft
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Perforator based interposition flap
Intervention Description
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.
Primary Outcome Measure Information:
Title
Expansion/contraction of the interpositioned skin after 3 months
Description
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?
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul P M Van Zuijlen, Prof
Organizational Affiliation
Red Cross Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Red Cross Hospital
City
Beverwijk
State/Province
Noord-Holland
ZIP/Postal Code
1942 LE
Country
Netherlands
Facility Name
Maastad Hospital
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Martini Hospital, Burns centre
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
12. IPD Sharing Statement
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