Post-Operative Dressings for Hernia Repair

Overseen By Benjamin Sarac, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Active smokers, Cardiac disease, Pulmonary disease, Renal disease, Hematologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Randomized controlled trial to compare SSO's in abdominal wall reconstruction patients using Prevena, Prineo, and traditional incisional dressings.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Prineo/Dermabond Prineo skin closure system safe for use in humans?

The Prineo/Dermabond Prineo skin closure system is generally safe for use in humans, but there have been reports of allergic reactions in some patients, particularly those with a history of adhesive allergies. These reactions may require treatment with medications like steroids. ^{1 2 3 4 5}

How does the treatment for post-operative dressings for hernia repair differ from other treatments?

The treatment uses the Dermabond Prineo system, which combines a liquid adhesive with a self-adhering mesh, offering a unique approach to wound closure that may reduce complications and improve healing compared to traditional sutures or other dressings. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment Prevena, Prevena Incision Management System, 3M Prevena Therapy, ciNPT, Closed Incision Negative Pressure Wound Therapy, Prineo, Dermabond Prineo, 2-octyl cyanoacrylate topical adhesive with flexible self-adhesive polyester mesh, Traditional, Standard Dressings, Conventional Dressings?

Research shows that the Prineo system, which combines a skin adhesive with a mesh, is effective in closing surgical wounds and reducing infections in various surgeries, such as cardiac and body-contouring procedures. This suggests it could be beneficial for hernia repair as well. ^{1 2 3 4 8}

Who Is on the Research Team?

Jeffrey E Janis, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My surgery wound will be stitched closed.

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

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

Exclusion Criteria

I am scheduled for a panniculectomy.

I need urgent surgery for a severe hernia that could harm my intestines.

Known allergy to any material used in any wound treatment (Prevena- Acrylic adhesive or silver, Prineo- Dermabond glue, Standard- Bacitracin, Xeroform, surgical tape)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Patients undergo a full history and physical examination, and fill out the PROMIS Pain Intensity survey

1 week

1 visit (in-person)

Surgery and Immediate Post-operative

Patients undergo surgery and receive one of the post-operative interventions: Prevena, Prineo, or Standard Dressing

1 week

1 visit (in-person)

Follow-up

Participants are monitored for ventral hernia recurrence, bulge, or other SSOs, and fill out surveys at 6 weeks, 3 months, and 1 year

1 year

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prevena
• Prineo
• Traditional

Trial Overview 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.

How Is the Trial Designed?

Group I: Prineo Experimental Treatment 1 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: Prevena Experimental Treatment 1 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 III: Standard Dressing Active Control 1 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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The Prineo Skin Closure System was found to be equivalent to intradermal sutures in closing surgical wounds, based on a study involving 83 patients undergoing various procedures.

This new adhesive system not only provided similar healing and cosmetic results but also significantly reduced closure time, being approximately 5 minutes faster than sutures, which can enhance surgical efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions. Richter, D., Stoff, A., Ramakrishnan, V., et al.[2022]

In a study of 1603 adult patients who underwent cardiac surgery, the use of the DERMABOND-PRINEO (PRINEO) skin closure system significantly reduced the incidence of surgical site infections (SSIs) to 1.8% compared to 3.8% in those using standard dressings.

PRINEO was found to be a safe option for wound closure after sternotomy, although it did not significantly affect the length of hospital stay or mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical skin adhesive PRINEO as the ideal wound closure system in cardiac surgery to limit surgical site infection. Gunga, Z., Marchese, MV., Pfister, R., et al.[2023]

The Prineo™ wound closure device, which combines a self-adhering mesh with a liquid adhesive, allows for quick and efficient closure of long incisions in excisional body-contouring surgery, improving surgical efficiency and patient comfort.

While the device is generally safe and well-received by patients, there is a small risk of intense local allergic reactions in about 1.8% of patients, requiring awareness and management by the surgeon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective wound closure with a new two-component wound closure device (Prineo™) in excisional body-contouring surgery: experience in over 200 procedures. Huemer, GM., Schmidt, M., Helml, GH., et al.[2016]

In a study of 21 patients undergoing reduction mammaplasty, the octyl-2-cyanoacrylate closure (Prineo) was found to be significantly faster, taking an average of 58.38 seconds per incision compared to 444.76 seconds for subcuticular sutures, saving about 6.4 minutes per incision.

Prineo closure demonstrated comparable scar quality to subcuticular sutures at 6 months and 1 year, with better scores at 2 weeks, indicating it is an effective and efficient alternative without increasing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Search of an Ideal Closure Method: A Randomized, Controlled Trial of Octyl-2-Cyanoacrylate and Adhesive Mesh versus Subcuticular Suture in Reduction Mammaplasty. Lee, JC., Ishtihar, S., Means, JJ., et al.[2021]

In a study involving 51 patients undergoing same-day bilateral total knee arthroplasties, Dermabond Prineo was found to provide quicker wound closure and shorter stitch-out times compared to subcuticular sutures, without compromising safety or causing more pain.

Both Dermabond Prineo and subcuticular sutures showed similar cosmetic outcomes at 6 months, indicating that Dermabond Prineo is an effective alternative for skin closure in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2-Octyl Cyanoacrylate Topical Adhesive as an Alternative to Subcuticular Suture for Skin Closure After Total Knee Arthroplasty: A Randomized Controlled Trial in the Same Patient. Choi, KY., Koh, IJ., Kim, MS., et al.[2022]

The DERMABOND PRINEO Skin Closure System is effective in optimizing scar healing and appearance after bilateral reduction mammoplasty, providing benefits like a watertight seal and reduced closure time.

However, caution is advised due to potential allergic reactions, as demonstrated by three patients who experienced rashes requiring systemic steroid treatment, particularly those with a history of adhesive allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rash with DERMABOND PRINEO Skin Closure System Use in Bilateral Reduction Mammoplasty: A Case Series. Knackstedt, RW., Dixon, JA., O'Neill, PJ., et al.[2020]

In a study of 347 knee arthroplasty patients, the mesh dressing (Dermabond® Prineo®) significantly reduced delayed wound healing (1.14%) compared to the standard dressing (AQUACEL® Ag) which had a rate of 9.36%.

The mesh dressing also resulted in fewer reoperations (0%) compared to the standard dressing (2.33%), suggesting that it may provide better wound support and tension distribution during the critical postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyester Mesh Dressings Reduce Delayed Wound Healing and Reoperations Compared with Silver-Impregnated Occlusive Dressings after Knee Arthroplasty. Anderson, FL., Herndon, CL., Lakra, A., et al.[2022]

In a study of 47 children undergoing 50 spine surgeries, the Dermabond Prineo (DP) skin closure system demonstrated a low revision rate for wound healing issues, with only 2% requiring additional surgery for complications like CSF leakage.

The use of DP resulted in high satisfaction rates among parents (97.9%) and excellent cosmetic outcomes, with physicians rating the appearance of wounds highly, suggesting that DP not only simplifies wound care but may also reduce the risk of infections and improve healing in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound closure with a mesh and liquid tissue adhesive (Dermabond Prineo) system in pediatric spine surgery: a prospective single-center cohort study incorporating parent-reported outcome measures. Stricker, S., Eberhard, N., Licci, M., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Topical skin adhesive PRINEO as the ideal wound closure system in cardiac surgery to limit surgical site infection. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effective wound closure with a new two-component wound closure device (Prineo™) in excisional body-contouring surgery: experience in over 200 procedures. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

In Search of an Ideal Closure Method: A Randomized, Controlled Trial of Octyl-2-Cyanoacrylate and Adhesive Mesh versus Subcuticular Suture in Reduction Mammaplasty. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

2-Octyl Cyanoacrylate Topical Adhesive as an Alternative to Subcuticular Suture for Skin Closure After Total Knee Arthroplasty: A Randomized Controlled Trial in the Same Patient. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Rash with DERMABOND PRINEO Skin Closure System Use in Bilateral Reduction Mammoplasty: A Case Series. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Polyester Mesh Dressings Reduce Delayed Wound Healing and Reoperations Compared with Silver-Impregnated Occlusive Dressings after Knee Arthroplasty. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Wound closure with a mesh and liquid tissue adhesive (Dermabond Prineo) system in pediatric spine surgery: a prospective single-center cohort study incorporating parent-reported outcome measures. [2023]