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?

This trial aims to determine which type of dressing best prevents surgical site infections in individuals undergoing hernia repair. It compares three different dressings: Prevena (a closed incision negative pressure wound therapy), Prineo (a topical adhesive with flexible self-adhesive polyester mesh), and traditional bandages. Individuals in good health who are undergoing elective ventral hernia repair may be suitable candidates. Participants will be randomly assigned one of the dressings after surgery to evaluate its effectiveness in preventing infections. As an unphased trial, this study allows participants to contribute to important research that could enhance post-surgical care for future patients.

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.

What prior data suggests that these post-operative dressings are safe for hernia repair?

Previous studies have shown that Prevena reduces wound problems such as infections and fluid buildup under the skin. Research indicates that Prevena uses gentle suction to enhance wound healing by lowering these risks. Over 220 studies support its safety and effectiveness.

For Prineo, studies have found that it uses a liquid glue and a mesh to close surgical cuts. This system is generally well-tolerated, though some users have reported minor issues like redness or fluid drainage. However, it often requires fewer dressing changes, which many find convenient.

Both Prevena and Prineo have strong safety records, making them promising options for surgery patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these post-operative dressing options, Prevena and Prineo, for hernia repair because they offer innovative approaches compared to traditional dressings. Prevena is unique because it uses negative pressure wound therapy, which can help reduce swelling and promote healing by drawing out excess fluid. Prineo, on the other hand, combines a mesh and a topical adhesive, providing a flexible and durable closure that may reduce the risk of infection and improve patient comfort. These advancements could potentially lead to faster recovery times and fewer complications, making them promising alternatives to standard wound dressings.

What evidence suggests that this trial's treatments could be effective for hernia repair?

Research has shown that Prevena, one of the treatments in this trial, uses gentle suction on closed wounds and can significantly reduce issues like infections and fluid buildup after surgery. Studies have found that using Prevena after operations, such as ventral hernia repairs, lowers the risk of infections and other wound complications.

Prineo, another treatment option in this trial, uses a special glue and mesh to close wounds. It has reduced infection rates and improved wound healing. This system keeps the wound sealed and protected, resulting in fewer bandage changes and quicker recovery. The trial evaluates both treatments, along with the standard dressing, for their effectiveness in reducing complications after surgery. ^{1 2 3 6 7}

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

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]

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 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]

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]

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 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10019176/

Closed Incision Negative Pressure Therapy versus ... Use of ciNPT was associated with reductions in surgical site complications, surgical site infection, seroma, dehiscence, and skin necrosis incidence.

2. multimedia.3m.com multimedia.3m.com/mws/media/2295561O/solventum-closed-incision-negative-pressure-therapy-clinical-compendium-en-us.pdf

Proactive Risk Management with closed incision negative ... Prevena Therapy delivers negative pressure therapy to the closed incision to help optimize outcomes and reduce complications. Over. 220 peer-reviewed ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1743919121003794

Prophylactic negative pressure wound therapy for closed ... Use of pNPWT for closed laparotomy incisions following ventral hernia repair can significantly reduce the rate of postoperative surgical site infection.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9072509/

Application of PREVENA (Surgical Incision Protection ... The aim of this study is to examine whether routine NPWT confers a lower rate of SSI than conventional dressings following reversal of ileostomy or colostomy.

5. solventum.com solventum.com/content/dam/public/language-masters/en/msb/document/2023/msd-ssm-prevena-clinical-he-evidence-summary-general-en_gbl.pdf

Clinical Evidence Summaries General Surgery The purpose of study was to examine whether closed incision negative pressure therapy, 3M. Prevena Therapy, reduced the rate of wound complications following ...

6. multimedia.3m.com multimedia.3m.com/mws/media/1906081O/3m-prevena-therapy-vascular-surgery-brochure.pdf

3m-prevena-therapy-vascular-surgery-brochure.pdf 3M™ Prevena™ Therapy is the first closed-incision negative pressure therapy (ciNPT) solution of its kind to reduce the risk or incidence of seromas and ...

7. gdmedical.nl gdmedical.nl/wp-content/uploads/2018/05/ciNPT-Copendium_3M-Prevena-Therapy_ENGnlbe.pdf

Proactive Risk Management with closed incision negative ... Prevena Therapy provides negative pressure therapy to the closed incision and surrounding soft tissues to help optimise outcomes and reduce complications. One ...