MedTrace Logo

Coupling Negative Pressure Wound Therapy With Instillation

NCT04677166 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-06-13

No results posted yet for this study

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

Interventions

DEVICE

Negative pressure wound therapy coupled with instillation

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

DEVICE

Standard Negative Pressure Wound Therapy

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

Sponsors & Collaborators

  • Acelity

    collaborator OTHER

  • KCI USA, Inc

    collaborator INDUSTRY

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Subhas W Gupta, MD, PhD · Loma Linda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2024-10-21
Completion
2024-10-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677166 on ClinicalTrials.gov