The Use of "Negative Pressure Drainage System" for Caring Split-thickness Skin Graft Recipient Sites
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Healing of the wound at the 7th day after operation
Study Overview
Brief Summary
To compare the efficacy and safety of negative pressure drainage system with controls (indirect saline soaks) in the coverage of recipient site wounds of split-thickness skin graft.
Detailed Description
Randomized, comparator-controlled trial in patients underwent split-thickness skin graft conducted in Taipei Veterans General Hospital between Aug. 2012 and Dec. 2013. (No.) patients age 21 to 60 years were randomly assigned in the intervention group (n= ) of negative pressure drainage system or to a control group (n= ) of traditional method. Patients who had immunologic disease, end-stage renal disease, coagulopathy, or history of radiation were excluded. The conditions of graft take and pain and discomfort were compared every day during the first 7 days after operation and 2 weeks and 3 months follow up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 21 to 60 years
- •The wounds located on limbs or trunk
- •The area of wounds is ranged 50 to 250cm2.
Exclusion Criteria
- •immunodeficiency disease
- •end stage renal disease
- •coagulopathy
- •history of radiation to the recipient site
- •allergy to the dressing
- •major medical problems
Outcomes
Primary Outcomes
Healing of the wound at the 7th day after operation
Time Frame: 1 week
Secondary Outcomes
- Pain, Comfort, and satisfication of the device(one week)
- Long term wound condition(three months)