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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two specific products, Stratafix sutures (a type of surgical suture) and Dermabond PRINEO (a skin closure system), for closing C-section wounds compared to usual methods. One group will have their C-section wounds treated with these new products, while another group will receive standard care. Women planning an elective C-section and who have internet access might be suitable candidates for this trial. As an unphased trial, it offers participants the opportunity to contribute to medical research that could enhance surgical outcomes for future patients.

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 prior data suggests that the Stratafix sutures and Dermabond PRINEO are safe for C-section wound closure?

Research has shown that using Stratafix stitches with Dermabond PRINEO is generally safe and well-tolerated. Stratafix stitches stay in place without knots, simplifying wound closure. Dermabond PRINEO acts as a skin glue, holding wound edges together and protecting the area.

In past studies, this combination was used successfully in various surgeries, such as spine surgeries. Some individuals might experience mild skin irritation from the adhesive, but serious side effects are rare. Overall, current evidence suggests that this wound closure method is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Stratafix Sutures combined with DERMABOND PRINEO for C-section wound closure because this approach offers a unique blend of strength and healing innovation. Unlike the standard sutures, Stratafix Sutures provide continuous tissue approximation, potentially enhancing wound strength and reducing the risk of gaps or infections. DERMABOND PRINEO adds a secure adhesive layer that not only protects the wound but also allows for greater flexibility and potentially faster healing. This combination might lead to improved cosmetic outcomes and patient satisfaction compared to traditional methods.

What evidence suggests that the Stratafix and Dermabond PRINEO wound closure bundle is effective for C-section wound closure?

This trial will compare the effectiveness of a bundled C-section wound closure using Stratafix Sutures and Dermabond PRINEO with the standard of care. Research has shown that Stratafix sutures with Dermabond PRINEO can improve wound healing. Studies have found that Stratafix sutures hold tissue together more strongly than regular stitches, which is particularly beneficial for C-section wounds. Dermabond PRINEO, a skin glue, helps keep wound edges together without extra stitches. Together, these tools aim to lower infection rates and enhance wound healing, especially for individuals with conditions like obesity and diabetes. Overall, this combination is designed to provide better wound protection and healing than standard methods. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

Citations

1. jnjmedtech.com jnjmedtech.com/en-US/product/stratafix-symmetric-pds-plus-knotless-tissue-control-device

STRATAFIX™ Knotless Tissue Control Device | Ethicon STRATAFIX Symmetric PDS Plus Devices demonstrated superior tissue holding strength compared to interrupted technique with Coated VICRYL™ (polyglactin 910) ...

2. jnjmedtech.com jnjmedtech.com/sites/default/files/user_uploaded_assets/pdf_assets/2021-04/080631-180205_SFX_DERMABOND%20PRINEO_CSection%20Value%20Brief_CA_approved.pdf

STRATAFIX™ Knotless Tissue Control Devices and the ... C-Section surgical site infection (SSI) rates can be as high as 19% and 16% in populations with prominent risk factors such as obesity and diabetes, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06614829

Study Details | NCT06614829 | Patient Reported ... 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 ...

4. ortomedic.no ortomedic.no/wp-content/uploads/2019/05/Delphi-Consensus-Study_summary.pdf

Orthopedic Experts Identify Best Practices for Wound ... Security refers to the ability to maintain optimal tissue approximation when damage to the closure device occurs. ¤Refers to STRATAFIX™ Symmetric PDS™ Plus ...

5. youtube.com youtube.com/watch?v=f7O0WO7Bm8k

Spine Surgery with STRATAFIX Surgical Sutures and ... Learn about the benefits of using STRATAFIX barbed sutures and DERMABOND PRINEO wound closure system in an anterior-approach spine surgery.

6. jnjmedtech.com jnjmedtech.com/sites/default/files/user_uploaded_assets/pdf_assets/2020-10/C-Section%20Value%20Brief%20080631-180205.pdf

STRATAFIX™ Knotless Tissue Control Devices and the ... Study to compare the tissue holding strength of DERMABOND® PRINEO® 22 cm Skin Closure System (DP22) to conventional wound closure techniques. AST-2014–0246 ...