NCT01922362

Negative Pressure Drainage System Split-thickness Skin Graft Recipient Sites

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Healing of STSG

Interventions

Type	Name	Description
DEVICE	Negative pressure drainage system	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.
DEVICE	Indirect wet dressing	The recipient site wound is covered with sulfa-tula first and then wet gauze.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-08-14
• Last updated: 2013-08-14

Locations

1 site across 1 country: Taiwan