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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

Must not have

Patients undergoing a panniculectomy

Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective ventral hernia repair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year postoperatively

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for a panniculectomy.

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I do not have severe heart, lung, kidney, or blood diseases.

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I have an open wound from recent surgery.

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My wound is oozing pus.

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I do not have a severe infection throughout my body.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Average Cost

Pain

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

866 Previous Clinical Trials

654,861 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.