Stratafix + Dermabond PRINEO for C-Section Wound Closure

(CS-PREO Trial)

Overseen By Mark Fan, MHSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: North York General Hospital

Disqualifiers: Intellectual disabilities, Emergency C-section, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of the study is to compare outcomes between patients receiving standard C-section wound closure compared to a wound closure bundle that includes Stratafix sutures and Dermabond PRINEO.

Will I have to stop taking my current medications?

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 data supports the effectiveness of the treatment DERMABOND PRINEO and STRATAFIX for C-section wound closure?

Research shows that DERMABOND PRINEO, a skin adhesive with a mesh, is effective in surgical wound closure by providing a strong bond and microbial protection, which helps in natural healing and infection control. STRATAFIX, a knotless suture, is beneficial for soft tissue closure, offering good cosmetic results and rapid recovery, as seen in general and gynecological surgeries. ^{1 2 3 4 5}

Is the Stratafix + Dermabond PRINEO system safe for wound closure in humans?

The Stratafix + Dermabond PRINEO system is generally considered safe for wound closure, but there have been reports of allergic reactions, such as rashes, in some patients. These reactions are rare but may require treatment, especially in individuals with a history of adhesive allergies. ^{1 2 3 4 5}

How is the treatment Stratafix + Dermabond PRINEO for C-section wound closure different from other treatments?

The Stratafix + Dermabond PRINEO treatment is unique because it combines a skin adhesive with a mesh to create a strong bond across wound edges, providing a microbial barrier and even tension distribution, which can lead to better cosmetic outcomes and faster healing compared to traditional sutures or staples. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for English-speaking adults over 18 who are planning an elective C-section between 13-36 weeks of pregnancy. They must have internet or smartphone access to fill out questionnaires and be covered by the Ontario Health Insurance Plan.

Inclusion Criteria

Patients opting for a planned (elective) C-Section (13-36 weeks gestation) will be eligible to consent

Patients must have internet access and/or a smartphone in order to access the digital platform to complete the study questionnaires

I am covered by the Ontario Health Insurance Plan.

Exclusion Criteria

Patients assessed by the participating surgeon with any conditions that may compromise their ability to consent or use the virtual care platform (e.g., patients with intellectual disabilities)

Patients who enroll in the study but have an unplanned emergency C-section

My surgeon thinks I have health issues that could complicate surgery due to pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo C-section with either standard wound closure or a wound closure bundle including Stratafix sutures and Dermabond PRINEO

1 week

1 visit (in-person)

Follow-up

Participants are monitored for surgical site infection, readmission, antibiotic prescription, and SCAR-Q scores

6 weeks

1 visit (in-person)

Treatment Details

Interventions

• DERMABOND PRINEO
• Stratafix Suture

Trial Overview The study compares standard wound closure techniques after a C-section with a new method using Stratafix sutures and DERMABOND PRINEO, focusing on patient experiences and infection rates.

Participant Groups

Group I: Control Active Control 1 Intervention

This group would be receiving the standard of care.

Group II: Bundled C-section Wound Closure Active Control 2 Interventions

Surgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing.

DERMABOND PRINEO is already approved in United States for the following indications:

Approved in United States as DERMABOND PRINEO for:

• Topical application to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.

Who Is Running the Clinical Trial?

North York General Hospital

Lead Sponsor

Trials

22

Recruited

8,800+

Johnson & Johnson

Collaborator

Trials

1

Recruited

70+

Johnson & Johnson

Industry Sponsor

Trials

116

Recruited

167,000+

Findings from Research

The DERMABOND™ PRINEO™ Skin Closure System offers a cosmetic advantage by using a strong adhesive that allows for natural healing while providing a microbial barrier, which can help reduce infection risk.

The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device enables efficient soft tissue closure without the need for knots, making it suitable for both large fascial and skin closures, thus improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing the Gap: Novel Abdominal Wound Closure Techniques. Kondrup, JD., Qayyum, AM.[2018]

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 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]

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]

A case study of a 47-year-old male revealed that Dermabond Prineo, while effective for wound closure, can cause allergic contact dermatitis after repeated use, particularly in spine surgeries.

The patient's allergic reaction was likely due to sensitization from prior use of Dermabond Prineo during a previous surgery, highlighting the need for healthcare providers to be cautious about its use in patients undergoing multiple procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis to Dermabond Prineo after abdominal wound closure for anterior lumbar interbody fusion: case report. Coppola, CM., Tobin, JG., Lawrence, JP.[2023]

References

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

Closing the Gap: Novel Abdominal Wound Closure Techniques. [2018]

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

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]

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

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

5. China pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis to Dermabond Prineo after abdominal wound closure for anterior lumbar interbody fusion: case report. [2023]