Coupling Negative Pressure Wound Therapy With Instillation

NCT ID: NCT04677166

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2024-10-21

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.

Conditions

Wound; Ulcer; Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Negative pressure wound therapy coupled with instillation

Intervention Type: DEVICE

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

Standard NPWT

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

Group Type: ACTIVE_COMPARATOR

Standard Negative Pressure Wound Therapy

Intervention Type: DEVICE

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

Interventions

Negative pressure wound therapy coupled with instillation

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

Intervention Type: DEVICE

Standard Negative Pressure Wound Therapy

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acelity

OTHER

Sponsor Role: collaborator

KCI USA, Inc

INDUSTRY

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Subhas W Gupta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda

Locations

Loma Linda University

Loma Linda, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29292216 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25162948 (View on PubMed)

Other Identifiers

5200176

Identifier Type: -

Identifier Source: org_study_id