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Dermal Substitute and Topical Negative Pressure in Burns (VAC-M)
This study is currently recruiting participants.
Study NCT00548314   Information provided by Association of Dutch Burn Centres
First Received: October 22, 2007   Last Updated: July 31, 2009   History of Changes

October 22, 2007
July 31, 2009
October 2007
December 2009   (final data collection date for primary outcome measure)
skin elasticity parameters (representing scar quality) [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
skin elasticity parameters (representing scar quality) [ Time Frame: after 3 months ]
Complete list of historical versions of study NCT00548314 on ClinicalTrials.gov Archive Site
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 ]
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 ]
 
Dermal Substitute and Topical Negative Pressure in Burns
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.

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.

Phase III
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Burns
  • Other: dermal matrix
  • Procedure: Split skin graft
  • Device: VAC therapy
  • Experimental: the selected wound will be treated with dermal substitute Matriderm, split skin graft (SSG) and VAC therapy
  • Experimental: the selected wound will be treated with dermal substitute Matriderm, and split skin graft
  • Experimental: the selected wound will be treated with split skin graft and VAC therapy
  • Active Comparator: the selected wound will be treated with split skin graft.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
72
December 2010
December 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Monica Bloemen, MD 0031251625291 mbloemen@rkz.nl
Netherlands
 
NCT00548314
Association of Dutch Burn Centres, Association of Dutch Burn Centres
07.109
Association of Dutch Burn Centres
no collaborators
Study Director: Esther Middelkoop, Professor Association of Dutch Burn Centres (ADBC)
Association of Dutch Burn Centres
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP