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Negative Pressure Wound Therapy

Negative Pressure Wound Therapy with Instillation for Wounds and Injuries

N/A
Recruiting
Led By Subhas W Gupta, MD, PhD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days from intervention
Awards & highlights

Study Summary

This trial is testing a new way to help skin grafts heal better by adding a step of flushing the wound with saline solution.

Who is the study for?
This trial is for patients needing a split-thickness skin graft on an arm or leg wound. They must be candidates for this treatment and not have abnormal healing due to connective tissue disorders or uncontrolled diabetes with HgbA1c levels above 9.Check my eligibility
What is being tested?
The study compares two methods: standard negative pressure wound therapy (NPWT) versus NPWT with instillation, using saline solution. The goal is to see which method helps skin grafts stick better after four days of treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of therapy, possible infection risk due to the nature of wound care, and skin irritation from the device or solutions used.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days from intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days from intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Skin Graft Take at Four Days Post-Operative
Secondary outcome measures
Percentage of Skin Graft Take at Thirty Days Post-Operative

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NPWT with InstillationExperimental Treatment1 Intervention
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 II: Standard NPWTActive Control1 Intervention
Standard NPWT with use of V.A.C. Ulta device employed at 125mmHg continuous suction.

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,949 Total Patients Enrolled
3MIndustry Sponsor
157 Previous Clinical Trials
31,454 Total Patients Enrolled
AcelityOTHER
5 Previous Clinical Trials
4,500 Total Patients Enrolled

Media Library

Negative pressure wound therapy coupled with instillation (Negative Pressure Wound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04677166 — N/A
Wound Research Study Groups: NPWT with Instillation, Standard NPWT
Wound Clinical Trial 2023: Negative pressure wound therapy coupled with instillation Highlights & Side Effects. Trial Name: NCT04677166 — N/A
Negative pressure wound therapy coupled with instillation (Negative Pressure Wound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04677166 — N/A
~2 spots leftby Dec 2024
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