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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days from intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,964 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team currently searching for participants?

"Affirmative. Clinicaltrials.gov's information affirms that this clinical trial is currently gathering participants since its initial post on January 19th 2021. Within the next 20 patients recruited, 1 site will be sufficient to reach their goal by April 2022 at the latest."

Answered by AI

Does the age limit for enrollment in this clinical experiment cap at 75?

"To be included into this research study, patients must be between 18 and 90 years old. Separately, there are 189 trials targeting minors and 933 for individuals over 65 years of age."

Answered by AI

Is it feasible for me to become involved in this trial?

"This clinical trial seeks to recruit 20 individuals between the ages of 18 and 90 that have been diagnosed with an ulcer. Notably, these potential participants must meet a specific criterion: they need to be offered split-thickness skin graft for treatment of extremity wounds."

Answered by AI

What is the estimated sample size of this research endeavor?

"Affirmative. The information on clinicaltrials.gov demonstrates that this trial is actively scouting for participants, having first been posted on January 19th 2021 and revised lastly April 20th 2022. A total of 20 patients must be enrolled from 1 medical centre."

Answered by AI

Recent research and studies

International Journal of SurgeryJournal

Negative-pressure Therapy Versus Conventional Therapy on Split-thickness Skin Graft: A Systematic Review and Meta-analysis

Yin, Yingchao, Ruipeng Zhang, Shilun Li, Jialiang Guo, Zhiyong Hou, and Yingze Zhang. 2018. “Negative-pressure Therapy Versus Conventional Therapy on Split-thickness Skin Graft: A Systematic Review and Meta-analysis”. International Journal of Surgery. Elsevier BV. doi:10.1016/j.ijsu.2017.12.020.

Journal of Burn Care & ResearchJournal

Prospective Randomized Controlled Trial Comparing Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy

Nguyen, Trang Q., Mieczyslawa Franczyk, Justine C. Lee, Matthew R. Greives, Annemarie O’Connor, and Lawrence J. Gottlieb. 2015. “Prospective Randomized Controlled Trial Comparing Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy”. Journal of Burn Care & Research. Oxford University Press (OUP). doi:10.1097/bcr.0000000000000089.

clinicaltrials.govStudy

Coupling Negative Pressure Wound Therapy With Instillation

2021. "Coupling Negative Pressure Wound Therapy With Instillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04677166.