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| Sponsored by: |
Association of Dutch Burn Centres |
|---|---|
| Information provided by: | Association of Dutch Burn Centres |
| ClinicalTrials.gov Identifier: | NCT00548314 |
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 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds |
| Estimated Enrollment: | 72 |
| Study Start Date: | October 2007 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
the selected wound will be treated with dermal substitute Matriderm, split skin graft (SSG) and VAC therapy
|
Other: dermal matrix Device: VAC therapy |
|
2: Experimental
the selected wound will be treated with dermal substitute Matriderm, and split skin graft
|
Other: dermal matrix |
|
3: Experimental
the selected wound will be treated with split skin graft and VAC therapy
|
Device: VAC therapy |
|
4: Active Comparator
the selected wound will be treated with split skin graft.
|
Procedure: Split skin graft |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Monica Bloemen, MD | 0031251625291 | mbloemen@rkz.nl |
| Netherlands, Noord-Holland | |
| Red Cross Hospital | Recruiting |
| Beverwijk, Noord-Holland, Netherlands, 1942 LE | |
| Contact: Monica Bloemen, MD 0031251265291 mbloemen@rkz.nl | |
| Principal Investigator: Monica Bloemen, MD | |
| Study Director: | Esther Middelkoop, Professor | Association of Dutch Burn Centres (ADBC) |
More Information
| Study ID Numbers: | 07.109 |
| Study First Received: | October 22, 2007 |
| Last Updated: | October 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00548314 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Matriderm Dermal matrix VAC therapy |
Split skin graft Burns Scar quality |
|
Burns Wounds and Injuries Disorders of Environmental Origin Cicatrix |
