Negative Pressure Wound Therapy for Skin Grafts

February 13, 2019 updated by: Zhu Jiayuan, First Affiliated Hospital, Sun Yat-Sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Negative pressure wound therapy
Negative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting.
Procedure: Negative pressure wound therapy
Negative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting.
Active Comparator: standard pressure bolster dressing
This method is traditional used in skin grafting wound.
Procedure: standard pressure bolster dressing
This method is traditional used in skin grafting wound.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
postsurgery week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS pain grade
Time Frame: postsurgery week 4
assess the pain of the wound at each visit time
postsurgery week 4
Skin graft survival rate
Time Frame: postsurgery week 2
The area of the skin graft has been survival percentage accounted for the entire
postsurgery week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital, Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiayuan Zhu, doctor, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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