Perforator Based Interposition Plasty

Burn Scar Contraction Clinical Trial

Official title:

Perforator Based Interposition Flaps for Sustainable Release of Burn Scar Contracture: a Reliable, Simple and Versatile Technique. A Randomised Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409759
• Other study ID #: 10104 and 10110
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2011
• Last updated: June 25, 2015
• Start date: July 2011
• Est. completion date: November 2013

Study information

• Verified date: June 2015
• Source: Association of Dutch Burn Centres
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn Scar Contraction

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Red Cross Hospital	Beverwijk	Noord-Holland
Netherlands	Martini Hospital, Burns centre	Groningen
Netherlands	Maastad Hospital	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Association of Dutch Burn Centres

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	3 months	No