Negative Pressure Drainage System Split-thickness Skin Graft Recipient Sites

Not Applicable

• Conditions: Wound Healing of STSG
• Interventions: Device: Negative pressure drainage system; Device: Indirect wet dressing

• Registration Number: NCT01922362
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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 Timeline

• Study Start: 2012-12
• Status Verified: 2013-08
• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-08-12
• Last Update Submitted: 2013-08-12
• Study First Posted: 2013-08-14
• Last Update Posted: 2013-08-14
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative pressure drainage system	Negative pressure drainage system	Negative pressure drainage system
Indirect wet dressing group	Indirect wet dressing	Indirect wet dressing

Primary Outcome Measures

Name	Time	Method
Healing of the wound at the 7th day after operation	1 week

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veteran General Hospital; 🇨🇳 Taipei, Taiwan