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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Dermabond Prineo for cesarean section closure?

Research shows that absorbable sutures, which are part of the treatment options, are preferred for cesarean skin closure because they reduce wound complications compared to metal staples. Additionally, both absorbable and nonabsorbable sutures have been found to be effective in minimizing wound complications and providing satisfactory cosmetic results. ^{1 2 3 4 5}

Is Dermabond Prineo safe for use in surgical procedures?

Dermabond Prineo, a skin adhesive used in surgeries, has been associated with allergic reactions in some patients, such as rashes and itching, especially in those with previous exposure to similar products. While it is generally effective for wound closure, caution is advised for individuals with a history of adhesive allergies. ^{6 7 8 9 10}

How does the treatment Dermabond Prineo differ from other treatments for cesarean section closure?

Dermabond Prineo, a skin glue, offers a unique approach to cesarean section closure by potentially reducing surgical time and improving scar aesthetics compared to traditional sutures. Unlike sutures, which can leave marks and require more time for closure, skin glue like Dermabond Prineo can provide a quicker and more cosmetically appealing result. ^{1 2 4 11 12}

What is the purpose of this trial?

The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.

Research Team

Russell Miller, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

I have had a cesarean hysterectomy.

I have had surgery with a vertical skin cut.

Adhesive or tape allergy

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

References

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

Suture Compared With Staples for Skin Closure After Cesarean Delivery: A Systematic Review and Meta-analysis. [2023]

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

Staples vs subcuticular sutures for skin closure at cesarean delivery: a metaanalysis of randomized controlled trials. [2012]

3. Brazil pubmed.ncbi.nlm.nih.gov

Absorbable suture. Best aesthetic outcome in cesarian scar1. [2019]

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

Comparison of Subcuticular Suture Materials in Cesarean Skin Closure. [2022]

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

Suture versus staples for skin closure after cesarean: a metaanalysis. [2015]

6. 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]

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

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

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]

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

Allergic Contact Dermatitis to Dermabond Prineo After Elective Orthopedic Surgery. [2021]

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

Type IV Hypersensitivity Reaction to Dermabond (2-Octyl Cyanoacrylate) in Plastic Surgical Patients: A Retrospective Study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Spontaneous complete migration of suture material after subcuticular continuous suture in cesarean section: a case report. [2018]

12. Mexico pubmed.ncbi.nlm.nih.gov

[Closure of the skin with cyanoacrylate in cesarean section]. [2006]