Clinical trial NCT01922362: Negative Pressure Drainage System Split-thickness Skin Graft Recipient Sites
Official title: The Use of "Negative Pressure Drainage System" for Caring Split-thickness Skin Graft Recipient Sites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Healing of STSG
Keywords: STSG
wound healing
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2013-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Healing of the wound at the 7th day after operation
timeFrame: 1 week
Secondary outcomes:
measure: Pain, Comfort, and satisfication of the device
timeFrame: one week
measure: Long term wound condition
timeFrame: three months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
References:
citation: 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.
citation: HINMAN 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.
citation: Vogt 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.
citation: Christian 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.
citation: Wang 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.
citation: Alvarez 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.
citation: Nemeth 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.
citation: Scherer 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.
citation: Petkar 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.
citation: Li 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.