Negative Pressure Drainage System Split-thickness Skin Graft Recipient Sites

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Negative Pressure Drainage System for Caring Split-thickness Skin Graft Recipient Sites

Conditions
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Wound Healing of STSG

Intervention / Treatment
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* Device: Negative pressure drainage system
* Device: Indirect wet dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative pressure drainage system<br>Negative pressure drainage system | Device: Negative pressure drainage system<br>* a close system surgical drain was placed over the graft with the length equal to the wound size. A silicon penrose drain with side holes on it covered the surgical drain to prevent direct contact of transparent film and the surgical drain, which led to poor drainage function. The penrose drains were excluded from the system during the test period due to the same function of a close system surgical drain with and without a penrose drain. A transparent film was place over the graft and drains and over a margin of the surrounding healthy skin.<br>|
| Active Comparator: Indirect wet dressing group<br>Indirect wet dressing | Device: Indirect wet dressing<br>* The recipient site wound is covered with sulfa-tula first and then wet gauze.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of the wound at the 7th day after operation |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, Comfort, and satisfication of the device |  | one week | 
| Long term wound condition | Such as area of non-healing, erosion, infection, or scar hypertrophy | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STSG, wound healing