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