Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01922362
Enrollment
60
Registered
2013-08-14
Start date
2012-12-31
Completion date
2014-12-31
Last updated
2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Healing of STSG

Keywords

STSG, wound healing

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.

Interventions

DEVICENegative 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.

DEVICEIndirect wet dressing

The recipient site wound is covered with sulfa-tula first and then wet gauze.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Healing of the wound at the 7th day after operation1 week

Secondary

MeasureTime frameDescription
Pain, Comfort, and satisfication of the deviceone week
Long term wound conditionthree monthsSuch as area of non-healing, erosion, infection, or scar hypertrophy

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026