Dermal Substitute and Topical Negative Pressure in Burns (VAC-M)

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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Other: dermal matrix; Device: VAC therapy (KCI); Procedure: Split skin graft

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Beverwijk, Noord-Holland, Netherlands, 1942 LE
      • Red Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days.	Other: dermal matrix; 1mm thickness matrix composed of collagen-elastin hydrolosate; Other Names: Matriderm; Device: VAC therapy (KCI); VAC therapy for 3-5 days 125mmHg
Experimental: 2; After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5.	Other: dermal matrix; 1mm thickness matrix composed of collagen-elastin hydrolosate; Other Names: Matriderm
Experimental: 3; After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days.	Device: VAC therapy (KCI); VAC therapy for 3-5 days 125mmHg
Active Comparator: 4; After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5.	Procedure: Split skin graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
skin elasticity parameters (representing scar quality)	after 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer)	after 3 months

Collaborators and Investigators

• Sponsor: Association of Dutch Burn Centres
• Investigators: Study Director: Esther Middelkoop, Professor, Association of Dutch Burn Centres (ADBC)

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 22, 2007
• First Submitted That Met QC Criteria: October 22, 2007
• First Posted (Estimate): October 23, 2007

Study Record Updates

• Last Update Posted (Estimate): March 24, 2011
• Last Update Submitted That Met QC Criteria: March 23, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Burns; Scar quality; Matriderm; Dermal matrix; VAC therapy; Split skin graft
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 07.109