Skin Glue vs Sutures for Cesarean Section Closure

Overseen By Russell Miller, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Vertical incision, Hysterectomy, Stillbirth, others

Compensation: Varies

Number of Visits: Unknown

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if skin glue (Dermabond Prineo) is more effective than stitches for closing cesarean section incisions. Researchers seek to identify which method results in better healing and fewer complications. Women scheduled for a cesarean delivery with a horizontal (Pfannenstiel) incision and giving birth to a live baby may qualify for this trial. As an unphased trial, participants contribute to valuable research that may enhance future cesarean delivery outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a contraindication (reason not to use) to routine postpartum pain medications, you may not be eligible to participate.

What prior data suggests that these skin closure methods are safe for cesarean section?

Research has shown that the Dermabond Prineo system safely closes the skin after a C-section. Studies found that patients using this system experienced fewer wound infections and complications compared to those using skin staples. It is also well-tolerated, with no major safety issues reported. This makes it a reliable choice for closing surgical cuts in cesarean deliveries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Dermabond Prineo for closing cesarean section incisions because it offers a unique alternative to traditional sutures. Unlike sutures, which require needlework to close the skin, Dermabond Prineo is a skin adhesive system that simplifies the process by sealing the incision with a special glue and mesh. This method can potentially reduce procedure time, minimize scarring, and lessen the risk of infection. Additionally, patients might experience greater comfort and ease of care since no stitches need to be removed.

What evidence suggests that this trial's treatments could be effective for cesarean section closure?

Research has shown that the Dermabond Prineo system effectively closes cuts from C-sections. In this trial, participants will join either the Dermabond Prineo Group or the Suture Group. Studies have found that patients using Dermabond Prineo experience fewer wound infections and complications compared to those with traditional skin staples. This method is also considered an easy and comfortable way to close the skin, with a low risk of infection at the surgery site. Early results suggest it could be useful for closing belly incisions after a C-section. This evidence supports its effectiveness in improving outcomes for cesarean deliveries. ^{1 2 4 6 7}

Who Is on the Research Team?

Russell Miller, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who are scheduled for their first or subsequent cesarean deliveries, whether during labor or before it starts. They must be having a Pfannenstiel skin incision and giving birth to a live infant at the time of cesarean delivery.

Inclusion Criteria

All women undergoing intrapartum or antepartum cesarean delivery

I am a woman aged 18 or older.

Birth of a live infant at time of cesarean delivery

Exclusion Criteria

Intrapartum stillbirth

Adhesive or tape allergy

I have had a cesarean hysterectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cesarean delivery with skin closure using either Dermabond Prineo or standard subcuticular suture

Intraoperative

Follow-up

Participants are monitored for patient satisfaction with their cesarean scar, wound infection, and other outcomes

Up to 6 weeks post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Dermabond Prineo
• Suture

Trial Overview The study compares two methods of closing incisions after cesarean sections: using Dermabond Prineo system versus standard subcuticular sutures (stitches under the skin). The goal is to see which method leads to better healing outcomes.

How Is the Trial Designed?

Group I: Dermabond Prineo Group Active Control 1 Intervention

At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.

Group II: Suture Group Placebo Group 1 Intervention

At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

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]

In a study of 60 patients who underwent plastic surgical breast procedures using Dermabond, 6.6% developed type IV hypersensitivity reactions, characterized by pruritus and skin rash occurring in the second week post-operation.

The findings suggest that the incidence of allergic reactions to Dermabond is significant enough that patients should be informed about this risk before its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type IV Hypersensitivity Reaction to Dermabond (2-Octyl Cyanoacrylate) in Plastic Surgical Patients: A Retrospective Study. Alotaibi, NN., Ahmad, T., Rabah, SM., et al.[2023]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06614829

Study Details | NCT06614829 | Patient Reported ... The purpose of this study is to evaluate patient experience and patient reported outcomes following cesarean delivery in women receiving either standard wound ...

2. jnjmedtech.com jnjmedtech.com/system/files/pdf/PRINEO-C-Section-Study-Stat-095109-210713.pdf

DERMABOND® PRINEO® - Study Stats Following C-section, patients in the DERMABOND PRINEO System group had fewer wound infections and wound complications compared to skin staples. For complete ...

3. gynaecologyjournal.com gynaecologyjournal.com/articles/1198/6-4-7-362.pdf

Dermabond™ Prineo™ skin closure system in caesarean ... Conclusion: Our preliminary results show that this skin closure system has a potential application for abdominal wall closure in case of C-section. It is at ...

4. ginekologiaipoloznictwo.com ginekologiaipoloznictwo.com/articles/skin-closure-at-cesarean-delivery-glue-vs-subcuticular-sutures-a-randomized-clinical-trial-83108.html

Skin Closure at Cesarean Delivery, Glue Vs Subcuticular ... The Dermabond glue is relatively an effective, comfortable, and easy method of skin closure after cesarean delivery with low risk for surgical site infection.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40047817/

Dermabond Prineo: a systematic review and meta-analysis Conclusion: In this review, Dermabond Prineo showed lower wound infection rates and a reduction in delayed wound healing. Further studies are ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28153666/

Skin closure at cesarean delivery, glue vs subcuticular ... Both methods were shown to be safe and successful for skin closure after a scheduled cesarean delivery and, therefore, can be used based on surgeon and patient ...

7. liebertpub.com liebertpub.com/doi/10.1089/gyn.2023.0038?doi=10.1089/gyn.2023.0038

The Dermabond Prineo Skin Closure System: Benefits and ... DP is safe, according to various studies. It has many advantages, such as cost and operating-time reduction, better cosmetic results, and-more-hygienic ...