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Incision Management System
Extended PREVENA Therapy for Post-Surgical Recovery
N/A
Recruiting
Research Sponsored by 3M
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 90 days
Awards & highlights
Study Summary
This trial evaluates Prevena Therapy's safety & effectiveness for up to 14 days after surgery, compared to current approved use for 7 days. Subjects will be monitored for up to 90 days.
Who is the study for?
This trial is for adults over 22 who can consent and return for follow-ups. It's for those having certain surgeries (orthopedic, abdominal, cardiac, or vascular) without infection risks but with factors like diabetes or smoking that could complicate healing. Pregnant women and chronic opioid users are excluded.Check my eligibility
What is being tested?
The study tests the Prevena Plus Incision Management System with dressings to see if using it up to 14 days post-surgery is as safe and effective as the current approved use of up to 7 days. Patients will be monitored for their recovery progress over a period of up to 90 days.See study design
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions due to dressing materials in contact with the skin or sensitivity to silver contained in the product components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Endpoint
Secondary outcome measures
Dehiscence
Hematoma
Seroma
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Subjects undergoing 1 of 4 types of surgery will be enrolled and treated with the PREVENA Plus Incision Management System
Find a Location
Who is running the clinical trial?
3MLead Sponsor
157 Previous Clinical Trials
31,121 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who is currently pregnant or breastfeeding, except if my surgery is a C-section.I am 22 years old or older.I have been using opioids for more than 3 months.I need surgery in one of these areas: leg, abdomen/C-section, chest, or blood vessels.I am scheduled for surgery on a wound that is either contaminated or infected.My upcoming surgery is expected to be clean or clean-contaminated.My surgical wound is closed and I need Prevena Therapy for more than 11 days.I have health risks or allergies that make surgery or the study unsafe for me.I currently have an infection in my surgery area or a body-wide infection.I have one or more high-risk factors for surgery complications, such as obesity, diabetes, smoking history, weak immune system, malnutrition, or a history of heart, lung, liver, kidney disease, or previous surgeries or radiation in the area to be treated.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many locations are overseeing the execution of this trial?
"Currently, 5 sites are enrolling patients in this experiment. These encompass locations such as Charleston, Raleigh and Dallas among others. It is important to pick the closest location to you when signing up for the trial since it will reduce transportation needs if enrolled."
Answered by AI
Is this research endeavor still accepting participants?
"This study, which had its initial listing on December 15th 2022 and last update on November 7th 2022, is no longer accepting patients. However, there are an additional 22 clinical trials that are still searching for participants at this time."
Answered by AI
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