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Perforator Based Interposition Plasty

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ClinicalTrials.gov Identifier: NCT01409759
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : June 26, 2015
Sponsor:
Information provided by:
Association of Dutch Burn Centres

August 3, 2011
August 4, 2011
June 26, 2015
July 2011
May 2013   (Final data collection date for primary outcome measure)
Expansion/contraction of the interpositioned skin after 3 months [ Time Frame: 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?
Same as current
Complete list of historical versions of study NCT01409759 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Perforator Based Interposition Plasty
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Burn Scar Contraction
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.
  • Experimental: 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.
    Intervention: Procedure: Perforator based interposition flap
  • Full thickness graft
    Intervention: Procedure: Perforator based interposition flap
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
November 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01409759
10104 and 10110
Yes
Not Provided
Not Provided
Association of Dutch Burn Centres
Association of Dutch Burn Centres
Not Provided
Principal Investigator: Paul P M Van Zuijlen, Prof Red Cross Hospital
Association of Dutch Burn Centres
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP