Dermal Substitute and Topical Negative Pressure in Burns

Burns Clinical Trial

— VAC-M  

Official title:

Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548314
• Other study ID #: 07.109
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2007
• Last updated: March 23, 2011
• Start date: October 2007
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Association of Dutch Burn Centres
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months.

Additionally, an increase of the take of graft and improvement of scar assessment scale, scar colour/pigmentation and time to complete wound closure, is expected.

Description:

The standard therapy for full thickness wounds is transplantation with a split thickness skin graft. However, scars usually develop as a result of this therapy. Previous research has demonstrated an improvement of scar quality if a dermal substitute was applied in combination with a split skin graft in reconstructive wounds, but not so much in burn wounds. One of the problems in burn wounds was the retarded outgrowth of the skin graft when a dermal substitute was applied in a one step procedure with the graft. Since then, application of topical negative pressure has demonstrated that the take and outgrowth of a skin graft can be improved by this technique. It now seems feasible to combine these two technologies in order to improve the quality of healing of burn wounds in the acute phase of healing.

Aim of the study is to investigate if application of a dermal substitute in combination with topical negative pressure can improve the quality of the scar in burn wounds.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients >=18 yrs with acute burns/trauma wounds that require skin grafting

• Minimal study wound surface 10 cm2

• Maximal study wound surface 300 cm2

• Maximal TBSA 15% full thickness wounds

• Informed consent

Exclusion Criteria:

• Patients with wounds without adequate possibility to apply VAC

• Immunocompromised patients

• Infected wounds

• Pregnant patients

• Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders (e.g. borderline or depression).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Other:
• dermal matrix
1mm thickness matrix composed of collagen-elastin hydrolosate

Procedure:
• Split skin graft

Device:
• VAC therapy (KCI)
VAC therapy for 3-5 days 125mmHg

Locations

Country	Name	City	State
Netherlands	Red Cross Hospital	Beverwijk	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Association of Dutch Burn Centres

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin elasticity parameters (representing scar quality)		after 3 months	No
Secondary	take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer)		after 3 months	No