Coupling Negative Pressure Wound Therapy With Instillation

NCT04677166 | Terminated FDA Device

• 1 other identifier: 5200176
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound; Ulcer; Burns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Skin Graft Take at Thirty Days Post-Operative

  30 days from intervention

Study Arms (2)

NPWT with Instillation

EXPERIMENTAL

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

Standard NPWT

ACTIVE COMPARATOR

Standard NPWT with use of V.A.C. Ulta device employed at 125mmHg continuous suction.

Device: Standard Negative Pressure Wound Therapy

Interventions

Negative pressure wound therapy coupled with instillation DEVICE

Use of V.A.C. VeraFlo to treat skin grafts with NPWT coupled with instillation.

NPWT with Instillation

Standard Negative Pressure Wound Therapy DEVICE

standard negative pressure wound therapy via V.A.C. Ulta device at 125mmHg suction.

Standard NPWT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead
• Acelity: collaborator
• KCI USA, Inc: collaborator

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Related Publications (2)

• 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.

  PMID: 29292216 BACKGROUND

• 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.

  PMID: 25162948 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Ulcer; Burns

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Subhas W Gupta, MD, PhD

  Loma Linda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to either the treatment group (negative pressure wound therapy coupled with instillation) or the control group (standard negative pressure wound therapy). Both groups will receive four days of intervention and outcomes will be measured at day four of negative pressure wound therapy and at thirty days post-operatively.

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 21, 2020
• Study Start: January 19, 2021
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)