Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures.

Ain Shams Maternity Hospital

Status

Completed

Conditions

Cesarean Wound; Dehiscence

Treatments

Procedure: Monocryl

Procedure: Glue (Dermabond®; Ethicon, Somerville, NJ).

Study type

Interventional

Funder types

Other

Identifiers

NCT04371549

Details and patient eligibility

About

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.

Full 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.

Enrollment

79 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Maternal Age: 20-40 years old.
BMI: 18.5 - 29.9 kg/m2.
Gestational Age: term pregnancy (≥ 37 weeks) and viable fetus.
Scheduled to undergo elective lower segment CD (category 4 CD).
Hemoglobin level: ≥ 10 gm/dl.

Exclusion criteria

Abnormal placental invasion (e.g., placenta previa).
Emergency CD (category 1, 2 and 3 CD).
Clinical signs of infection at the time of CD.
Medical disorder (Diabetes, Hypertension, Cardiac, Hepatic or renal disorder).
Uterine anomalies (e.g., septum, Mullerian anomalies or fibroids).
Previous CD not using Pfannenstiel method (e.g., midline incision).
Known hypersensitivity to any of the suture materials or glue used in the protocol, or any disorders requiring chronic corticosteroids or immune suppressants.
History of surgical site infection after previous CD.