Burns Clinical Trial - Coupling Negative Pressure Wound Therapy With

Status Recruiting

Clinical Trial Summary

The objective of this study is to compare standard negative pressure wound therapy with negative pressure wound therapy coupled with instillation for optimal skin graft take. Either the V.A.C ULTA NPWT or V.A.C. VeraFlo Therapy systems with normal saline will be applied intra-operatively to split-thickness skin grafts of upper and lower extremity wounds and kept in place for a duration of four days. Following completion of four days, the skin graft with be assessed for percentage of take/adherence and will be covered with simple gauze dressings as needed.

Clinical Trial Description

Past studies have investigated the use of NPWT for post-operative skin graft treatment and shown superior outcomes regarding graft take and need for repeat grafting when compared with standard gauze dressing. However, to date, no study has compared standard NPWT to NPWT coupled with instillation for post-operative treatment of extremity skin grafts. This study is designed as a randomized, controlled pilot study to compare treatment standard NPWT with NPWT coupled with instillation on skin graft take. Patients will be selected based on inclusion criteria and randomized to either the treatment (NPWT coupled with instillation) or the control group (standard NPWT). Depending on the group to which they are randomized to, patients will have standard NPWT or NPWT coupled with instillation applied intra-operatively after application of split thickness skin graft for treatment of extremity wound. Patients randomized to control group will receive V.A.C Ulta NPWT at 125mmHg continuous pressure for duration of four days. Patients randomized to treatment group will receive V.A.C VeraFlo therapy. Protocol will consist of the following: - Instillation solution: normal saline - Dwell/soak time: 30 seconds - Cycle Time: 4 hours - Pressure: 125mmHg The devices will be kept in place for four days, at which point, the wound vacs will be removed and the percentage of skin graft take will be evaluated with use of photometric analysis. The skin grafts will be subsequently dressed with gauze as appropriate. Patients will be followed up in clinic to assess outcome of skin graft take. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04677166
Study type	Interventional
Source	Loma Linda University
Contact	Stephanie W Holzmer, MD
Phone	(909) 558-8085
Email	sholzmer@llu.edu
Status	Recruiting
Phase	N/A
Start date	January 19, 2021
Completion date	December 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Coupling Negative Pressure Wound Therapy With Instillation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms