Perforator Based Interposition Plasty

NCT ID: NCT01409759

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-11-30

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

Conditions

Burn Scar Contraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Perforator based interposition flap

Intervention Type: PROCEDURE

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

Group Type: OTHER

Perforator based interposition flap

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Association of Dutch Burn Centres

OTHER

Sponsor Role: lead

Responsible Party

Association of Dutch Burn Centres

Principal Investigators

Paul P M Van Zuijlen, Prof

Role: PRINCIPAL_INVESTIGATOR

Red Cross Hospital

Locations

Red Cross Hospital

Beverwijk, North Holland, Netherlands

Maastad Hospital

Rotterdam, South Holland, Netherlands

Martini Hospital, Burns centre

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

10104 and 10110

Identifier Type: -

Identifier Source: org_study_id