The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction

NCT00609908 | Completed Phase 3

• 1 other identifier: 06.201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: A randomized controlled trial is performed to evaluate the clinical effectiveness of the skin stretching technique for two categories:

• surface area;
• Patient and Observer Scar Assessment Scale (POSAS);
• elasticity;
• vascularization and pigmentation;
• thickness;
• dermal architecture. After 12 months adults will undergo a biopsy of the scar under local anesthesia. The experimental group, treated with the skin stretcher will undergo one extra biopsy of the formerly stretched skin. Intervention: At the start of the operation will be determined by randomization if skin stretching or split skin grafting (acute burn wounds) or serial excision (scar reconstruction category) will be performed.

Conditions

Burns; Scars

Outcome Measures

Primary Outcomes (1)

• the surface area of the scar after 12 months

  3 and 12 months after surgery

Secondary Outcomes (1)

• scar evaluation protocol: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularization & pigmentation (DermaSpectrometer); - scar thickness

  3 and 12 months after surgery

Study Arms (4)

A1

ACTIVE COMPARATOR

Acute Burn Wounds: Wound debridement and split skin grafting

Procedure: Split skin graft

A2

EXPERIMENTAL

Acute Burn Wounds: excision of the burn wound and primary closure, using a skin stretching device

Procedure: skin stretching device

B1

ACTIVE COMPARATOR

Scar reconstruction: serial excision

Procedure: serial excision

B2

EXPERIMENTAL

Scar reconstruction: primary closure, using skin stretching device

Procedure: skin stretching device

Interventions

Split skin graft PROCEDURE

After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)

A1

skin stretching device PROCEDURE

after woundbed preparation the wound is primarily closed by aid of the skin stretching device

A2

serial excision PROCEDURE

as much scar as possible is excised, whereafter the wound is closed

B1

Eligibility Criteria

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

You may qualify if:

• Acute Burn wounds or scar reconstructions that require surgical treatment;
• Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure;
• Age \>= 18 years.

You may not qualify if:

• Language barrier;
• Known history of keloid formation;
• Systemic diseases: Diabetes Mellitus, immunodeficiency, arterial insufficiency;
• Local or systemic application of corticosteroids;
• Psychiatric diseases leading to study bias (e.g. automutilation);
• Skin diseases that lead to collagen and/or elastin abnormalities such as Ehlers Danlos;
• Radiated skin;
• Wound located at extremities, exceeding \>33% of circumference (acute burn category).

Sponsors & Collaborators

• Association of Dutch Burn Centres: lead

Study Sites (1)

Red Cross Hospital

Beverwijk, Netherlands

Location

MeSH Terms

Conditions

Burns; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• E Middelkoop, Professor

  VU MC

  PRINCIPAL INVESTIGATOR

• P.P.M. van Zuijlen, MD, PhD

  Red Cross Hospital Beverwijk

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 7, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

NL (1)