Perforator Based Interposition Plasty
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Burn Scar Contraction |
Procedure: Perforator based interposition flap |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Perforator Based Interposition Flaps for Sustainable Release of Burn Scar Contracture: a Reliable, Simple and Versatile Technique. A Randomised Controlled Trial. |
- Expansion/contraction of the interpositioned skin after 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]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?
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Procedure: Perforator based interposition flap
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 |
Procedure: Perforator based interposition flap
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.
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Carlijn Stekelenburg, MD | 0031251265459 | cstekelenburg@rkz.nl |
| Contact: Marlies Kobesen | 0031251275500 | mkobesen@burns.nl |
| Netherlands | |
| Red Cross Hospital | Recruiting |
| Beverwijk, Noord-Holland, Netherlands, 1942 LE | |
| Contact: Carlijn M Stekelenburg, MD 0031251265459 cstekelenburg@rkz.nl | |
| Contact: Roos Marck, MD 0031251265542 rmarck@rkz.nl | |
| Principal Investigator: Carlijn M Stekelenburg, MD | |
| Maastad Hospital | Not yet recruiting |
| Rotterdam, Zuid-Holland, Netherlands, 3079 DZ | |
| Contact: Margriet E van Baar, PhD 003110 - 2913428 baarm@maasstadziekenhuis.nl | |
| Martini Hospital, Burns centre | Not yet recruiting |
| Groningen, Netherlands, 9728 NZ | |
| Contact: Marianne K Nieuwenhuis, PhD +31 (0)50-5245245 ext 5565 m.k.nieuwenhuis@mzh.nl | |
| Principal Investigator: Marianne K Nieuwenhuis, PhD | |
| Principal Investigator: | Paul P M Van Zuijlen, Prof | Red Cross Hospital |
More Information
No publications provided
| Responsible Party: | Association of Dutch Burn Centres |
| ClinicalTrials.gov Identifier: | NCT01409759 History of Changes |
| Other Study ID Numbers: | 10104 and 10110 |
| Study First Received: | August 3, 2011 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Association of Dutch Burn Centres:
|
Perforators Interposition plasty Contracture release |
Additional relevant MeSH terms:
|
Burns Contracture Cicatrix Wounds and Injuries Joint Diseases |
Musculoskeletal Diseases Muscular Diseases Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013