NCT04371549

Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures.

Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The optimal choice of skin closure at cesarean delivery has not yet been determined. This study will compare wound complications and scar healing following cesarean delivery between 2 methods of skin closure: glue (Dermabond®; Ethicon, Somerville, NJ) and monofilament (Monocryl®; Ethicon) epidermal sutures.

Detailed description

Cesarean delivery (CD) rates have increased during the last few decades and it has become the most common surgery during women's reproductive years . However, despite its prevalence, data regarding many aspects of the preferred surgical technique are sparse. Skin closure is an integral step of CD. It influences postoperative pain, wound healing, cosmetic outcome, and surgeon and patient satisfaction There is currently no definite evidence regarding the best method for skin closure after cesarean delivery. Staples have been suggested as inferior to other techniques . Given the conflicting data available, obstetricians are forced to base their decisions on personal preference. Dermabond® glue (Ethicon Inc, Somerville, NJ) is a liquid monomer that forms a strong tissue bond with a protective barrier that adds strength and inhibits bacteria. An in vitro study found that glue inhibits both gram-positive (methicillin-resistant Staphylococcus aureus and Staphylococcus epidermidis) and gram-negative (Escherichia coli) bacteria . In addition, glue has the potential advantages of rapid application and repair time. It has been shown to achieve cosmetically similar results compared to staples within 12 months of the repair. Also, glue was shown to be well-accepted by patients . To date, there have been no randomized clinical trials comparing skin closure with glue to sutures using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS is a validated and reliable instrument that is practical for assessing scars . It is comprehensive and correlates well with patient ratings. The Observer Scar Assessment Scale rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable is ranked from 1-10, with 1 representing normal skin. Ratings are summed to obtain a total score ranging from 5-50. The Patient Scar Assessment Scale consists of 6 items: scar-related pain, itchiness, color, stiffness, thickness, and irregularity. Each item is ranked from 1-10, with 1 representing normal skin. Total score ranges from 6-60. Previous studies regarding skin closure with glue were small, retrospective, and included mixed populations and varying surgical techniques. Therefore, clear, conclusive recommendations are lacking. Dermabond® is a liquid monomeric (2-octyl cyanoacrylate) formulation that undergoes an exothermic reaction upon exposure to moisture, changing to polymers that form a strong tissue bond. The wound will not be dressed with an abdominal pad or adhesive tape according to manufacturer's instructions.

Conditions

• Cesarean Wound; Dehiscence

Interventions

Type	Name	Description
PROCEDURE	Glue (Dermabond®; Ethicon, Somerville, NJ).	Arm 1: Skin after cesarean section will be closed by glue
PROCEDURE	Monocryl	Arm 2: Skin after cesarean section will be closed by running subcuticular sutures using synthetic absorbable monofilament

Timeline

• Start date: 2020-08-25
• Primary completion: 2021-01-31
• Completion: 2021-03-01
• First posted: 2020-05-01
• Last updated: 2022-11-22

Locations

1 site across 1 country: Egypt