Negative Pressure Drainage System Split-thickness Skin Graft Recipient Sites

NCT ID: NCT01922362

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

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Wound Healing of STSG

Keywords

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STSG wound healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Negative pressure drainage system

Negative pressure drainage system

Group Type EXPERIMENTAL

Negative pressure drainage system

Intervention Type DEVICE

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.

Indirect wet dressing group

Indirect wet dressing

Group Type ACTIVE_COMPARATOR

Indirect wet dressing

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Indirect wet dressing

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Veteran General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Tien-Hsiang Wang, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 14007593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14087904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7639486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10632683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19505763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6887836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1952972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18766042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21723044 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22286487 (View on PubMed)

Other Identifiers

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2012-12-022B

Identifier Type: -

Identifier Source: org_study_id