Coupling Negative Pressure Wound Therapy With Instillation

Not Applicable

Terminated

• Conditions: Wound; Ulcer; Burns
• Interventions: Device: Negative pressure wound therapy coupled with instillation; Device: Standard Negative Pressure Wound Therapy

• Registration Number: NCT04677166
• Lead Sponsor: Loma Linda University

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-21
• Study Start: 2021-01-19
• Primary Completion: 2024-10-21
• Study Completion: 2024-10-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Patients who have been offered split-thickness skin graft for treatment of an extremity wound.

Exclusion Criteria

• Abnormal healing (diagnosed with connective tissue disorder)
• Uncontrolled diabetes mellitus (HgbA1c >9)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPWT with Instillation	Negative pressure wound therapy coupled with instillation	NPWT coupled with instillation will be employed via use of V.A.C. VeraFlo device. The protocol to be used is as follows: Instillation Solution: normal saline Dwell/Soak Time: 30 seconds Cycle Time: 4 hours Pressure: 125mmHg
Standard NPWT	Standard Negative Pressure Wound Therapy	Standard NPWT with use of V.A.C. Ulta device employed at 125mmHg continuous suction.

Primary Outcome Measures

Name	Time	Method
Percentage of Skin Graft Take at Four Days Post-Operative	4 days from intervention	percentage of skin graft take at time of wound vac take down (4 days post-op)

Secondary Outcome Measures

Name	Time	Method
Percentage of Skin Graft Take at Thirty Days Post-Operative	30 days from intervention	percentage of skin graft take at follow up clinic appointment

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States