Coupling Negative Pressure Wound Therapy With Instillation

Coupling Negative Pressure Wound Therapy With Instillation for Optimal Graft Take: Randomized Prospective Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Burns; Ulcer; Wound
• Intervention / Treatment: Device: Negative pressure wound therapy coupled with instillation; Device: Standard Negative Pressure Wound Therapy

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NPWT 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	Device: Negative pressure wound therapy coupled with instillation; Use of V.A.C. VeraFlo to treat skin grafts with NPWT coupled with instillation.
Active Comparator: Standard NPWT; Standard NPWT with use of V.A.C. Ulta device employed at 125mmHg continuous suction.	Device: Standard Negative Pressure Wound Therapy; standard negative pressure wound therapy via V.A.C. Ulta device at 125mmHg suction.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Acelity; KCI USA, Inc
• Investigators: Principal Investigator: Subhas W Gupta, MD, PhD, Loma Linda

Publications and helpful links

General Publications

• Yin Y, Zhang R, Li S, Guo J, Hou Z, Zhang Y. Negative-pressure therapy versus conventional therapy on split-thickness skin graft: A systematic review and meta-analysis. Int J Surg. 2018 Feb;50:43-48. doi: 10.1016/j.ijsu.2017.12.020. Epub 2017 Dec 29.
• Nguyen TQ, Franczyk M, Lee JC, Greives MR, O'Connor A, Gottlieb LJ. Prospective randomized controlled trial comparing two methods of securing skin grafts using negative pressure wound therapy: vacuum-assisted closure and gauze suction. J Burn Care Res. 2015 Mar-Apr;36(2):324-8. doi: 10.1097/BCR.0000000000000089.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Actual): October 21, 2024
• Study Completion (Actual): October 21, 2024

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 5200176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No