Negative Pressure Drainage System Split-thickness Skin Graft Recipient Sites

Taipei Veterans General Hospital

Status: Unknown

Conditions: Wound Healing of STSG

Treatments: Device: Negative pressure drainage system; Device: Indirect wet dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT01922362

2012-12-022B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Negative pressure drainage system

Experimental group

Description:

Negative pressure drainage system

Treatment:

Device: Negative pressure drainage system

Indirect wet dressing group

Active Comparator group

Description:

Indirect wet dressing

Treatment:

Device: Indirect wet dressing