Negative Pressure Wound Therapy for Skin Grafts

NCT02374528 | Completed DMC

• 1 other identifier: 2015046
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief 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, 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.

Conditions

Skin Transplantation

Keywords

Negative pressure wound therapy; wound; split-thickness skin grafting

Outcome Measures

Primary Outcomes (1)

• 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.

  postsurgery week 4

Secondary Outcomes (2)

• VAS pain grade

  postsurgery week 4

• Skin graft survival rate

  postsurgery week 2

Study Arms (2)

Negative pressure wound therapy

EXPERIMENTAL

Negative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting.

Procedure: Negative pressure wound therapy

standard pressure bolster dressing

ACTIVE COMPARATOR

This method is traditional used in skin grafting wound.

Procedure: standard pressure bolster dressing

Interventions

Negative pressure wound therapy PROCEDURE

Negative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting.

Negative pressure wound therapy

standard pressure bolster dressing PROCEDURE

This method is traditional used in skin grafting wound.

standard pressure bolster dressing

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Related Publications (1)

• 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.

  PMID: 36161796 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Jiayuan Zhu, Doctor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, vice director of surgery

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 2, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02