Wound Healing of STSGNCT01922362
Negative Pressure Drainage System Split-thickness Skin Graft Recipient Sites
A study testing Negative pressure drainage system and Indirect wet dressing in people with Wound Healing of STSG, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Wound Healing of STSG
- What is being tested?
- Negative pressure drainage system and Indirect wet dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 21 to 60 years
- The wounds located on limbs or trunk
- The area of wounds is ranged 50 to 250cm2.
Who cannot join
- immunodeficiency disease
- end stage renal disease
- coagulopathy
- history of radiation to the recipient site
- allergy to the dressing
- major medical problems
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veteran General Hospital
Taipei
Tien-Hsiang Wang, MD, 886-2-2875-7542, wangts@vghtpe.gov.tw
About this study
Official title: The Use of "Negative Pressure Drainage System" for Caring Split-thickness Skin Graft Recipient Sites
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.
Read the 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.
- Conditions
- Wound Healing of STSG
- Being tested
- Negative pressure drainage system, Indirect wet dressing
- Keywords
- STSG, wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure drainage systemDevice
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 dressingDevice
The recipient site wound is covered with sulfa-tula first and then wet gauze.
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure drainage system | Experimental | Negative pressure drainage system Receives: Device: Negative pressure drainage system |
| Indirect wet dressing group | Active comparator | Indirect wet dressing Receives: Device: Indirect wet dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the wound at the 7th day after operation
Measured: 1 week
Secondary outcomes (2)
Pain, Comfort, and satisfication of the device
Measured: one week
Long term wound condition
Such as area of non-healing, erosion, infection, or scar hypertrophy
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Wound Healing of STSGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922362
- Sponsor's protocol ID
- 2012-12-022B
- Status last verified
- Aug 2013
- First submitted
- 12 Aug 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14007593HINMAN 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.
PubMed 14087904Vogt 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.
PubMed 7639486Christian 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.
PubMed 10632683Wang 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.
PubMed 19505763Alvarez 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.
PubMed 6887836Nemeth 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.
PubMed 1952972Scherer 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.
PubMed 18766042Petkar 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.
PubMed 21723044Li 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.
PubMed 22286487
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of "Negative Pressure Drainage System" for Caring Split-thickness Skin Graft Recipient Sites
- ClinicalTrials.gov ID
- NCT01922362
- Acronym / sponsor ID
- 2012-12-022B
- Conditions
- Wound Healing of STSG
- Keywords
- STSG, wound healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative pressure drainage system | Experimental | Device: Negative pressure drainage systemNegative pressure drainage system |
| Indirect wet dressing group | Active comparator | Device: Indirect wet dressingIndirect wet dressing |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 21 to 60 years
- The wounds located on limbs or trunk
- The area of wounds is ranged 50 to 250cm2.
Key exclusion criteria (6 listed)
- immunodeficiency disease
- end stage renal disease
- coagulopathy
- history of radiation to the recipient site
- allergy to the dressing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure drainage systema 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. | Device | Negative pressure drainage system |
| Indirect wet dressingThe recipient site wound is covered with sulfa-tula first and then wet gauze. | Device | Indirect wet dressing group |
Primary outcome
Healing of the wound at the 7th day after operation
Time frame: 1 week
2 secondary outcomes
Pain, Comfort, and satisfication of the device
Time frame: one week
Long term wound condition
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Background: PubMed 14007593WINTER 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.
- Background: PubMed 14087904HINMAN 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.
- Background: PubMed 7639486Vogt 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.
- Background: PubMed 10632683Christian 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.
- Background: PubMed 19505763Wang 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.
- Background: PubMed 6887836Alvarez 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.
- Background: PubMed 1952972Nemeth 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.
- Background: PubMed 18766042Scherer 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.
- Background: PubMed 21723044Petkar 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.
- Background: PubMed 22286487Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure drainage system and Indirect wet dressing in people with Wound Healing of STSG, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of the wound at the 7th day after operation (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922362, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.