MedTrace Logo

Perforator Based Interposition Plasty

NCT01409759 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-06-26

No results posted yet for this study

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.

Conditions

  • Burn Scar Contraction

Interventions

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.

Sponsors & Collaborators

  • Association of Dutch Burn Centres

    lead OTHER

Principal Investigators

  • Paul P M Van Zuijlen, Prof · Red Cross Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-05-31
Completion
2013-11-30

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409759 on ClinicalTrials.gov