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Negative Pressure Wound Therapy
Negative Pressure Wound Therapy for Surgical Wounds
Phase 3
Waitlist Available
Led By Mario Leitao, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 +/- 5 days after surgery
Awards & highlights
Study Summary
This trial is comparing the Prevena Incision Management System (a type of Negative Pressure Wound Therapy) to using the usual standard dry gauze approach.
Who is the study for?
This trial is for women aged 18 or older undergoing laparotomy surgery, either for suspected gynecologic cancer or any reason if they are morbidly obese (BMI ≥ 40). It's not suitable for those with open incisions classified as 'contaminated' or 'dirty', who need panniculectomy, have tissue damage preventing closure of the wound, or are sensitive to silver.Check my eligibility
What is being tested?
The study compares the Prevena Incision Management System—a vacuum device that helps draw fluid out from surgical wounds—with standard dry gauze care. The goal is to see which method leads to better healing and fewer complications post-surgery.See study design
What are the potential side effects?
Potential side effects may include skin irritation around the wound site, discomfort from the pressure of the vacuum device, possible allergic reactions if there's sensitivity to materials used in Prevena system like foam or adhesives.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days +/- 5 days after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days +/- 5 days after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of post-op wound complications
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prevena Negative Pressure Wound Therapy System (NPWT)Experimental Treatment1 Intervention
Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first.
Group II: usual standard dry gauze used for wound managementActive Control1 Intervention
Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
The Prevena Incision Management System
2016
Completed Phase 3
~580
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,233 Total Patients Enrolled
3MIndustry Sponsor
157 Previous Clinical Trials
30,897 Total Patients Enrolled
Miami Cancer InstituteOTHER
5 Previous Clinical Trials
368 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who are allergic to silver.
Research Study Groups:
This trial has the following groups:- Group 1: Prevena Negative Pressure Wound Therapy System (NPWT)
- Group 2: usual standard dry gauze used for wound management
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Prevena Incision Management System received official backing from the FDA?
"The Prevena Incision Management System is a Phase 3 trial, which means that it has received some efficacy data and multiple rounds of safety data. This gives it a score of 3 on our team's safety scale."
Answered by AI
In how many hospitals is this research project being conducted?
"Memorial Sloan Kettering Monmouth (Consent and Follow-Up only), Memorial Sloan Kettering Bergen (Consent and Follow-Up only), and Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only) are just a few of the 11 sites participating in this clinical trial."
Answered by AI
Are we looking for more participants in this clinical trial at the moment?
"This particular clinical trial is not looking for patients at the moment, as indicated on clinicaltrials.gov. The last time this study was edited was March 1st, 2022 and it was first posted February 1st, 2016. Although there are no current plans to recruit more participants, there are 768 other medical trials that patients can sign up for."
Answered by AI
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