A Randomised Controlled Trial Comparing Vacuum Assisted Closure (V.A.C.®) With Modern Wound Dressings
Current treatment modalities for chronic leg ulcers are time consuming, expensive, and only moderately successful. Recent data suggest that creating a sub-atmospheric pressure by Vacuum Assisted Closure (V.A.C.®) therapy supports the wound healing process. Here, we studied the efficacy of V.A.C.® in the treatment of chronic leg ulcers prospectively.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||State-of-the Art Treatment of Chronic Leg Ulcers: a Randomised Controlled Trial Comparing Vacuum Assisted Closure (V.A.C.®) With Modern Wound Dressings|
- Time-to-complete-healing: i.e. the period between initial preparation of the wound and 100% epithelialisation with the primary endpoint being time-to-complete-healing.
- 1)duration of the wound-bed preparation stage
- 2)percentage of leg ulcer recurrences within one year (i.e. an epithelial breakdown anywhere along or within the index ulcer region)
- 3)skin-graft survival, where applicable (i.e. percentage of successfully adhered skin grafts after 4 days of complete bed rest and compression or VAC® treatment)
- 4) the quality of life
- 5) pain scores
- 6) the total time needed for wound care until complete wound closure
- 7) the costs per ulcer.
|Study Start Date:||May 2001|
|Estimated Study Completion Date:||May 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243620
|Department of dermatology|
|Maastricht, 6202 Az, Netherlands, 5800|
|Principal Investigator:||Jeroen Vuerstaek, MD||Department of dermatology, UniversityHospital Maastricht|
|Study Chair:||Peter Steijlen, Prof.||Department of dermatology, University Hospital Maastricht|