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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00548314
First Posted: October 23, 2007
Last Update Posted: March 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Association of Dutch Burn Centres
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT00548314     History of Changes
Other Study ID Numbers: 07.109
First Submitted: October 22, 2007
First Posted: October 23, 2007
Last Update Posted: March 24, 2011
Last Verified: March 2011

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