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Post-Operative Dressings for Hernia Repair

N/A

Recruiting

Led By Jeffrey E Janis, MD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who will have a closed incision following the surgery

Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year postoperatively

Awards & highlights

Study Summary

This trial is comparing the effectiveness of different types of incisional dressings for abdominal reconstruction patients.

Who is the study for?

This trial is for adults over 18 who are undergoing elective ventral hernia repair and have a closed incision post-surgery. Candidates should be in good health without life-threatening diseases or severe systemic sepsis, open wounds after surgery, or known allergies to materials used in the dressings. Active smokers and emergency hernia repairs are excluded.Check my eligibility

What is being tested?

The study is a randomized controlled trial comparing the effectiveness of different wound treatments—Prevena, Prineo, and traditional dressings—in preventing complications at the surgical site after abdominal wall reconstruction.See study design

What are the potential side effects?

Potential side effects may include skin reactions like irritation or allergy to dressing materials such as acrylic adhesive, silver (in Prevena), Dermabond glue (in Prineo), Bacitracin, Xeroform, or surgical tape.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery wound will be stitched closed.

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I am considered fit for surgery and do not have severe heart, lung, kidney, or blood diseases.

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I am scheduled for elective surgery to repair a ventral hernia.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Hernia recurrence

Rate of Infection

Skin

Secondary outcome measures

Average Cost

Pain

Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PrineoExperimental Treatment1 Intervention

Patients will then be randomized to group A (Prevena™) or group B (Prineo™) or group C (Standard wound dressing) using a random number generator made in Microsoft Excel. They will be made aware of which group they are in after the consent and randomization process, in order for proper post-operative teaching during the pre-operative clinic visit. The principal investigator, co-investigators and operating room staff will be aware of which post-operative intervention is being used on the day of surgery.

Group II: PrevenaExperimental Treatment1 Intervention

Group III: Standard DressingActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prevena

2018

Completed Phase 4

~370

Prineo

2014

N/A

~30

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,335 Total Patients Enrolled

4 Trials studying Hernia

616 Patients Enrolled for Hernia

Jeffrey E Janis, MD4.25 ReviewsPrincipal Investigator - Ohio State University

Ohio State University

1 Previous Clinical Trials

70 Total Patients Enrolled

1 Trials studying Hernia

70 Patients Enrolled for Hernia

1Patient Review

I was extremely disappointed with my breast reduction. I was left with breasts that are too small and excessively scarred. I don't believe that a 36H should be reduced to a B cup.

Media Library

Prevena Clinical Trial Eligibility Overview. Trial Name: NCT04906408 — N/A

Hernia Research Study Groups: Prevena, Prineo, Standard Dressing

Hernia Clinical Trial 2023: Prevena Highlights & Side Effects. Trial Name: NCT04906408 — N/A

Prevena 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906408 — N/A

Frequently Asked Questions

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

What is the participant size of this medical research?

"Indeed, clinicaltrials.gov specifies that this research endeavour is currently looking for participants - it was initially posted on September 17th 2021 and its most recent update occurred on the 23rd of said month. In total, 300 individuals must be recruited from a single site."

Answered by AI

Are individuals being enrolled in this research endeavor currently?

"From what is listed on clinicaltrials.gov, this investigation is currently recruiting participants. This research was initially published on September 17th 2021 and went through its most recent update 6 days later."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of Post-Operative Interventions on Surgical Site Occurrences in AWR

Jeffrey Janis 2021. "The Effects of Post-Operative Interventions on Surgical Site Occurrences in AWR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04906408.

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