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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. |
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| 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. |
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| 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 |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 72 | ||||
| Start Date † | October 2007 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | |||||
| Contacts †† |
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| Location Countries † | Netherlands | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00548314 | ||||
| Organization ID | 07.109 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Association of Dutch Burn Centres | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Association of Dutch Burn Centres | ||||
| Verification Date | October 2007 | ||||
| First Received Date † | October 22, 2007 | ||||
| Last Updated Date | October 26, 2007 | ||||