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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 12, 2013
CompletedFirst Posted
Study publicly available on registry
August 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 14, 2013
August 1, 2013
2 years
August 12, 2013
August 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Healing of the wound at the 7th day after operation
1 week
Secondary Outcomes (2)
Pain, Comfort, and satisfication of the device
one week
Long term wound condition
three months
Study Arms (2)
Negative pressure drainage system
EXPERIMENTALNegative pressure drainage system
Indirect wet dressing group
ACTIVE COMPARATORIndirect wet dressing
Interventions
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.
The recipient site wound is covered with sulfa-tula first and then wet gauze.
Eligibility Criteria
You may qualify if:
- Aged 21 to 60 years
- The wounds located on limbs or trunk
- The area of wounds is ranged 50 to 250cm2.
You may not qualify if:
- immunodeficiency disease
- end stage renal disease
- coagulopathy
- history of radiation to the recipient site
- allergy to the dressing
- major medical problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Veteran General Hospital
Taipei, Taiwan
Related Publications (10)
WINTER GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962 Jan 20;193:293-4. doi: 10.1038/193293a0. No abstract available.
PMID: 14007593BACKGROUNDHINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. doi: 10.1038/200377a0. No abstract available.
PMID: 14087904BACKGROUNDVogt PM, Andree C, Breuing K, Liu PY, Slama J, Helo G, Eriksson E. Dry, moist, and wet skin wound repair. Ann Plast Surg. 1995 May;34(5):493-9; discussion 499-500. doi: 10.1097/00000637-199505000-00007.
PMID: 7639486BACKGROUNDChristian MM, Behroozan DS, Moy RL. Delayed infections following full-face CO2 laser resurfacing and occlusive dressing use. Dermatol Surg. 2000 Jan;26(1):32-6. doi: 10.1046/j.1524-4725.2000.99042.x.
PMID: 10632683BACKGROUNDWang TH, Ma H, Yeh FL, Lin JT, Shen BH. The use of "composite dressing" for covering split-thickness skin graft donor sites. Burns. 2010 Mar;36(2):252-5. doi: 10.1016/j.burns.2009.04.003. Epub 2009 Jun 7.
PMID: 19505763BACKGROUNDAlvarez OM, Mertz PM, Eaglstein WH. The effect of occlusive dressings on collagen synthesis and re-epithelialization in superficial wounds. J Surg Res. 1983 Aug;35(2):142-8. doi: 10.1016/0022-4804(83)90136-1.
PMID: 6887836BACKGROUNDNemeth AJ, Eaglstein WH, Taylor JR, Peerson LJ, Falanga V. Faster healing and less pain in skin biopsy sites treated with an occlusive dressing. Arch Dermatol. 1991 Nov;127(11):1679-83.
PMID: 1952972BACKGROUNDScherer SS, Pietramaggiori G, Mathews JC, Prsa MJ, Huang S, Orgill DP. The mechanism of action of the vacuum-assisted closure device. Plast Reconstr Surg. 2008 Sep;122(3):786-797. doi: 10.1097/PRS.0b013e31818237ac.
PMID: 18766042BACKGROUNDPetkar KS, Dhanraj P, Kingsly PM, Sreekar H, Lakshmanarao A, Lamba S, Shetty R, Zachariah JR. A prospective randomized controlled trial comparing negative pressure dressing and conventional dressing methods on split-thickness skin grafts in burned patients. Burns. 2011 Sep;37(6):925-9. doi: 10.1016/j.burns.2011.05.013. Epub 2011 Jul 1.
PMID: 21723044BACKGROUNDLi TS, Choong MY, Wu HF, Chung KC. Simplified negative-pressure wound therapy system for skin graft wounds. Plast Reconstr Surg. 2012 Feb;129(2):399e-401e. doi: 10.1097/PRS.0b013e31823af1a8. No abstract available.
PMID: 22286487BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2013
First Posted
August 14, 2013
Study Start
December 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 14, 2013
Record last verified: 2013-08