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

This study is currently recruiting participants.
Study NCT00548314.   Last updated on October 26, 2007.   Information provided by Association of Dutch Burn Centres

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Descriptive Information Fields
Brief Title  Dermal Substitute and Topical Negative Pressure in Burns
Official Title  Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds
Brief 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.

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 Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary Outcome Measure  skin elasticity parameters (representing scar quality) [ Time Frame: after 3 months ]
Secondary Outcome Measure  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 ]
Condition  Burns
Intervention  Other: dermal matrix
Procedure: Split skin graft
Device: VAC therapy
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  72
Start Date  October 2007
Completion Date
Eligibility 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).
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers
Contacts ††
Contact: Monica Bloemen, MD     0031251625291     mbloemen@rkz.nl    
Location Countries  Netherlands
Administrative Information Fields
NCT ID  NCT00548314
Organization ID 07.109
Secondary IDs ††
Study Sponsor  Association of Dutch Burn Centres
Collaborators ††
Investigators 
Study Director:     Esther Middelkoop, Professor     Association of Dutch Burn Centres (ADBC)    
Information Provided By Association of Dutch Burn Centres
Verification Date October 2007
First Received Date  October 22, 2007
Last Updated Date October 26, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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