A randomised controlled multcenter trial is performed to evaluate the perforator-based interposition plasty in comparison to full thichness grafts for scar contracture releases.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The contraction of the flap/graft after three and twelve months is the primary
outcome measure.
Secondary outcome
Secundary outcome parameters are necrosis, pigmentation, flap elasticity, range
of motion and cosmetic outcome.
Background summary
Scar contraction after transplantation of the skin, remains a considerable
problem and reconstruction is frequently indicated. Local flaps offer the best
quality of tissue (normal skin and subcutaneaous fat) but the usage is limited
by availability and vascularisation. Since the discovery of perforators many
types of new skin flaps can be harvested as long as it incorporates a
perforator bundle of an artery and a vein. Based on literature and our own
experience we present a concept of a flap design based on perforator vessels
and local available skin. This concept should lead to an increased functional
outcome and flap survival. The implications of the use of perforator based
flaps for scar surgery by means of a RCT have to be determined yet.
Study objective
A randomised controlled multcenter trial is performed to evaluate the
perforator-based interposition plasty in comparison to full thichness grafts
for scar contracture releases.
Study design
Patients who require surgery for release of a scar contracture in one of the
three burn centers, are eligable for this study. Prior to surgery, perforators
will be identified by Doppler in the adjacent area of normal skin. A peninsular
flap will be designed. Measurements are performed (length, width, angle of
rotation, and the surface area of the flap). Then, the treatment is allocated
by randomisation. Follow up will take place after 1 and 3 weeks for survival
and after 3 and 12 months for contraction, as well as flap elasticity, colour,
range of motion and cosmetic outcome.
Intervention
Full thickness graft versus perforator-based interposition flap.
Study burden and risks
For patients undergoing the new technique no extra riscs are expected in
comparison to the stnadard technique: a full thickness graft. We expect that
the perforator based interposition flap results in an increase of the surface
area and an increased survival and fast wound healing because of the adequate
vascularisation.
Vondellaan 13
Beverwijk 1940 EB
NL
Vondellaan 13
Beverwijk 1940 EB
NL
Listed location countries
Age
Inclusion criteria
Indication for release of scar contracture
Sufficient tissue for a perforator based interposition flap
Able to give informed consent
Exclusion criteria
Age >= 12 years
Location: scars on face or scul
Smoking: the patient is eligiable if smoking is quit for > 3 weeks before the operation
Psychiatric disorders (if a problematic follow-up is anticipated)
Language barrier
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34053.094.10 |