Perforator Based Interposition Plasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Association of Dutch Burn Centres.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT01409759
First received: August 3, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Burn Scar Contraction
Procedure: Perforator based interposition flap
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perforator Based Interposition Flaps for Sustainable Release of Burn Scar Contracture: a Reliable, Simple and Versatile Technique. A Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Association of Dutch Burn Centres:

Primary Outcome Measures:
  • Expansion/contraction of the interpositioned skin after 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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?


Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Full thickness graft 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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409759

Contacts
Contact: Carlijn Stekelenburg, MD 0031251265459 cstekelenburg@rkz.nl
Contact: Marlies Kobesen 0031251275500 mkobesen@burns.nl

Locations
Netherlands
Red Cross Hospital Recruiting
Beverwijk, Noord-Holland, Netherlands, 1942 LE
Contact: Carlijn M Stekelenburg, MD    0031251265459    cstekelenburg@rkz.nl   
Contact: Roos Marck, MD    0031251265542    rmarck@rkz.nl   
Principal Investigator: Carlijn M Stekelenburg, MD         
Maastad Hospital Not yet recruiting
Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
Contact: Margriet E van Baar, PhD    003110 - 2913428    baarm@maasstadziekenhuis.nl   
Martini Hospital, Burns centre Not yet recruiting
Groningen, Netherlands, 9728 NZ
Contact: Marianne K Nieuwenhuis, PhD    +31 (0)50-5245245 ext 5565    m.k.nieuwenhuis@mzh.nl   
Principal Investigator: Marianne K Nieuwenhuis, PhD         
Sponsors and Collaborators
Association of Dutch Burn Centres
Investigators
Principal Investigator: Paul P M Van Zuijlen, Prof Red Cross Hospital
  More Information

No publications provided

Responsible Party: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT01409759     History of Changes
Other Study ID Numbers: 10104 and 10110
Study First Received: August 3, 2011
Last Updated: August 3, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Association of Dutch Burn Centres:
Perforators
Interposition plasty
Contracture release

Additional relevant MeSH terms:
Burns
Contracture
Cicatrix
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014