Skin TransplantationNCT02374528
Negative Pressure Wound Therapy for Skin Grafts
A study testing Negative pressure wound therapy and standard pressure bolster dressing in people with Skin Transplantation, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
The repairing of various wounds is always a great challenge in burn surgery and plastic surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to secure the graft to the wound bed, however, there is some evidence to show that irregularly contoured recipient sites, poorly healing areas… Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Skin Transplantation
- What is being tested?
- Negative pressure wound therapy and standard pressure bolster dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2018
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who need to skin graft to repair the wound
- Subjects signed the informed consent in the day of the age of not more than 85 years old (for minors, legal guardian should be signed)
- Stable vital signs, regular examination showed that subjects could tolerate surgery
- Subjects' mental state are good, could follow the doctor's advice, visit on a regular basis
- Understanding and willing to participate in this clinical trial and signed informed consent
- All women subjects must agree to take effective contraceptive measures in the six months study period, and without pregnancy before participate in the treatment
- No other serious diseases conflicts with the trail
Who cannot join
- Allergic constitution of negative pressure dressing
- Severe uncontrolled disease or acute systemic infections and complication with other serious heart, lung disease, encephalopathy and other organs or have a rapid progress or terminal disease
- Subjects with mental illness
- Subjects could not cooperate with the clinical trial personnel to finish trials
- Existing disease (malignant tumor, autoimmune disease) or require the use of drugs (high-dose glucocorticoids, which is defined as accepting 40 mg or more daily prednisone or prednisone amount, period of two weeks or more) will affect the healing of the wound
- For HIV positive patients, clinical diagnosis of patients with AIDS or the screening phase of neutrophil count (ANC) absolutely < 1000 cells/mm3
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- Subjects could not tolerate surgery
- Subjects are unlikely to survive in the study period
- The investigators think that who should not be included
- Subjects are in or participated in other clinical researchers over the past 12 weeks
- Subjects are participated in this trial at any time in the past
About this study
Official title: Clinical Randomized Controlled Trials on Negative Pressure Wound Therapy for Skin Grafts
The repairing of various wounds is always a great challenge in burn surgery and plastic surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to secure the graft to the wound bed, however, there is some evidence to show that irregularly contoured recipient sites, poorly healing areas, reduce the success rate of skin-grafting with traditional bolster dressings, increasing morbidity, pain. Negative pressure wound therapy has been advocated as a potential solution to some of these issues. To further test the healing rate and safety of this new method, the investigators propose a prospective randomized controlled trial to compare this method with traditional bolster dressings application in skin-grafting.
Read the detailed description
The repairing of various wounds is always a great challenge in burn surgery and plastic surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to secure the graft to the wound bed, however, there is some evidence to show that irregularly contoured recipient sites, exuding wounds, poorly healing areas, and the presence of shear stress significantly reduce the success rate of skin-grafting with traditional bolster dressings, increasing morbidity, pain, hospital stay, and cost. Negative pressure wound therapy (NPWT) has been advocated as a potential solution to some of these issues. the application of NPWT to skin-grafting may promote blood flow and microcirculation to the graft bed, reduction of edema, exudates, and hematomas, and result in significant qualitative improvement in split skin graft take. To further test the healing rate and safety of this new method, the investigators propose a prospective randomized controlled trial to compare this method with traditional bolster dressings application in skin-grafting.
- Conditions
- Skin Transplantation
- Being tested
- Negative pressure wound therapy, standard pressure bolster dressing
- Keywords
- Negative pressure wound therapy, wound, split-thickness skin grafting
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapyProcedure or surgery
Negative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting.
standard pressure bolster dressingProcedure or surgery
This method is traditional used in skin grafting wound.
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure wound therapy | Experimental | Negative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting. Receives: Procedure: Negative pressure wound therapy |
| standard pressure bolster dressing | Active comparator | This method is traditional used in skin grafting wound. Receives: Procedure: standard pressure bolster dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing rate (the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements)
the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements.
Measured: postsurgery week 4
Secondary outcomes (2)
VAS pain grade
assess the pain of the wound at each visit time
Measured: postsurgery week 4
Skin graft survival rate
The area of the skin graft has been survival percentage accounted for the entire
Measured: postsurgery week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin TransplantationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Jiayuan, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jiayuan Zhu, Doctor, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374528
- Sponsor's protocol ID
- 2015046
- Status last verified
- Feb 2019
- First submitted
- 23 Feb 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cao X, Hu Z, Zhang Y, Wang P, Huang S, Zhu W, Dong Y, Xu H, Tang B, Zhu J. Negative-Pressure Wound Therapy Improves Take Rate of Skin Graft in Irregular, High-Mobility Areas: A Randomized Controlled Trial. Plast Reconstr Surg. 2022 Dec 1;150(6):1341-1349. doi: 10.1097/PRS.0000000000009704. Epub 2022 Sep 27.
PubMed 36161796
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Randomized Controlled Trials on Negative Pressure Wound Therapy for Skin Grafts
- ClinicalTrials.gov ID
- NCT02374528
- Acronym / sponsor ID
- 2015046
- Conditions
- Skin Transplantation
- Keywords
- Negative pressure wound therapy, wound, split-thickness skin grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 2 Mar 2015 (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.
The repairing of various wounds is always a great challenge in burn surgery and plastic surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to secure the graft to the wound bed, however, there is some evidence to show that irregularly contoured recipient sites, poorly healing areas, reduce the success rate of skin-grafting with traditional bolster dressings, increasing morbidity, pain. Negative pressure wound therapy has been advocated as a potential solution to some of these issues. To further test the healing rate and safety of this new method, the investigators propose a prospective randomized controlled trial to compare this method with traditional bolster dressings application in skin-grafting.
Detailed description
The repairing of various wounds is always a great challenge in burn surgery and plastic surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to secure the graft to the wound bed, however, there is some evidence to show that irregularly contoured recipient sites, exuding wounds, poorly healing areas, and the presence of shear stress significantly reduce the success rate of skin-grafting with traditional bolster dressings, increasing morbidity, pain, hospital stay, and cost. Negative pressure wound therapy (NPWT) has been advocated as a potential solution to some of these issues. the application of NPWT to skin-grafting may promote blood flow and microcirculation to the graft bed, reduction of edema, exudates, and hematomas, and result in significant qualitative improvement in split skin graft take. To further test the healing rate and safety of this new method, the investigators propose a prospective randomized controlled trial to compare this method with traditional bolster dressings application in skin-grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative pressure wound therapy | Experimental | Procedure: Negative pressure wound therapyNegative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting. |
| standard pressure bolster dressing | Active comparator | Procedure: standard pressure bolster dressingThis method is traditional used in skin grafting wound. |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who need to skin graft to repair the wound
- Subjects signed the informed consent in the day of the age of not more than 85 years old (for minors, legal guardian should be signed)
- Stable vital signs, regular examination showed that subjects could tolerate surgery
- Subjects' mental state are good, could follow the doctor's advice, visit on a regular basis
- Understanding and willing to participate in this clinical trial and signed informed consent
Key exclusion criteria (11 listed)
- Allergic constitution of negative pressure dressing
- Severe uncontrolled disease or acute systemic infections and complication with other serious heart, lung disease, encephalopathy and other organs or have a rapid progress or terminal disease
- Subjects with mental illness
- Subjects could not cooperate with the clinical trial personnel to finish trials
- Existing disease (malignant tumor, autoimmune disease) or require the use of drugs (high-dose glucocorticoids, which is defined as accepting 40 mg or more daily prednisone or prednisone amount, period of two weeks or more) will affect the healing of the wound
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 wound therapyNegative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting. | Procedure or surgery | Negative pressure wound therapy |
| standard pressure bolster dressingThis method is traditional used in skin grafting wound. | Procedure or surgery | standard pressure bolster dressing |
Primary outcome
healing rate (the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements)
Time frame: postsurgery week 4
the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements.
2 secondary outcomes
VAS pain grade
Time frame: postsurgery week 4
Skin graft survival rate
Time frame: postsurgery week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 36161796Cao X, Hu Z, Zhang Y, Wang P, Huang S, Zhu W, Dong Y, Xu H, Tang B, Zhu J. Negative-Pressure Wound Therapy Improves Take Rate of Skin Graft in Irregular, High-Mobility Areas: A Randomized Controlled Trial. Plast Reconstr Surg. 2022 Dec 1;150(6):1341-1349. doi: 10.1097/PRS.0000000000009704. Epub 2022 Sep 27.
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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.
Jiayuan Zhu, Doctor principal investigator
First Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure wound therapy and standard pressure bolster dressing in people with Skin Transplantation, run by First Affiliated Hospital, Sun Yat-Sen University.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing rate (the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements) (time frame: postsurgery week 4). 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 NCT02374528, which also lists 1 linked publication.
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 15 Feb 2019.