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

This study has been completed.
Sponsor:
Information provided by:
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT00548314
First received: October 22, 2007
Last updated: March 23, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Burns
 Other: dermal matrix
Procedure: Split skin graft
Device: VAC therapy (KCI)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars
U.S. FDA Resources

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

Primary Outcome Measures:
  • skin elasticity parameters (representing scar quality) [ Time Frame: after 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer) [ Time Frame: after 3 months ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: October 2007
Study Completion Date: February 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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
-

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548314

Locations
Netherlands
Red Cross Hospital
Beverwijk, Noord-Holland, Netherlands, 1942 LE
Sponsors and Collaborators
Association of Dutch Burn Centres
Investigators
Study Director: Esther Middelkoop, Professor Association of Dutch Burn Centres (ADBC)
  More Information

No publications provided

Responsible Party: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT00548314     History of Changes
Other Study ID Numbers: 07.109
Study First Received: October 22, 2007
Last Updated: March 23, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Association of Dutch Burn Centres:
Matriderm
Dermal matrix
VAC therapy
 Split skin graft
Burns
Scar quality

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013