Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures.
Condition: Cesarean Wound; Dehiscence
Study type: Interventional

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.
    

Intervention name(s): Glue (Dermabond®; Ethicon, Somerville, NJ).; Monocryl
Intervention type(s): Procedure; Procedure
Intervention description(s): Arm 1: Skin after cesarean section will be closed by glue; Arm 2: Skin after cesarean section will be closed by running subcuticular sutures using synthetic absorbable monofilament
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment