Clinical trial NCT04371549: Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures.
Official title: Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Wound; Dehiscence
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 79
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Patient and Observer Scar Assessment Scale (POSASv2.0):
timeFrame: one week after cesarean section
measure: The Patient and Observer Scar Assessment Scale (POSASv2.0):
timeFrame: one month after cesarean section
Secondary outcomes:
measure: Surgeons' satisfaction scale:
timeFrame: immediately after the procedure
measure: Duration of surgery
timeFrame: in minutes from closure of the subcutaneous fat layer to closure of the skin
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
Study officials:
affiliation: AinShams university
name: Mahmoud K Mohammed, M.B.B.Ch
role: PRINCIPAL_INVESTIGATOR
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