Perforator Based Interposition Plasty

NCT01409759 | Completed Phase 2 DMC

• 1 other identifier: 10104 and 10110
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Perforators; Interposition plasty; Contracture release

Outcome Measures

Primary Outcomes (1)

• Expansion/contraction of the interpositioned skin after 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?

  3 months

Study Arms (2)

Perforator based interposion flap

EXPERIMENTAL

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

Full thickness graft

OTHER

Procedure: Perforator based interposition flap

Interventions

Perforator based interposition flap PROCEDURE

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; Perforator based interposion flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for release of burn scar contracture
• Sufficient tissue for a perforator- based interposition flap (preferably normal skin)
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Association of Dutch Burn Centres: lead

Study Sites (3)

Red Cross Hospital

Beverwijk, North Holland, 1942 LE, Netherlands

Location

Maastad Hospital

Rotterdam, South Holland, 3079 DZ, Netherlands

Location

Martini Hospital, Burns centre

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Paul P M Van Zuijlen, Prof

  Red Cross Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 4, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

NL (3)