Cosmetic Outcomes With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section

Università degli Studi dell'Insubria

Status: Completed

Conditions: Cesarean Section

Treatments: Procedure: Tissue adhesive; Procedure: Staples

Study type: Interventional

Funder types: Other

Identifiers

NCT04302597

GLUE-1

Details and patient eligibility

About

Recent clinical trials were developed to test the outcomes of skin closure with tissue adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel incision: both clinical outcomes such as blood loss, surgical site infection, length of postpartum hospitalization, or wound disruption, as well as Patient and Observer Scar Assessment Scale (POSAS) scores 8 weeks after surgery, were comparable between these different skin closure methods.

Despite the available studies are often based on robust methodologies and appropriate assessment scales, most of them were aimed to evaluate cosmetic outcomes in primary cesarean section, whereas data analyses published so far do not allow to draw a firm conclusion about repeated cesarean sections. Based on these elements, the aim of this study is to evaluate cosmetic outcomes after skin closure of Pfannenstiel incision with tissue adhesive or staples in a selected population undergoing repeated cesarean section.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous cesarean section with Pfannenstiel incision (regardless of the indication, emergency/urgency, weeks of pregnancy and years passed from the previous cesarean section)
• Maternal age 18-45 years
• Singleton pregnancy at 37-41 weeks of gestation (based on first-trimester ultrasound) with a viable fetus

Exclusion criteria

• History of keloids
• Previous transversal suprapubic scars
• Clinical signs of infection and/or tattoos in the area to be studied
• Known patient hypersensitivity to any of the suture materials used in the protocol
• BMI below 20 or above 30
• Any medical disorder that could affect wound healing, including severe malnutrition, conditions requiring chronic corticosteroid use or immune suppressant, uncontrolled diabetes mellitus (defined as Hemoglobin A1c > 6%, unbalanced daily glucose measurements, and fasting glucose >95 mg/dL).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Staples

Active Comparator group

Description:

Women who underwent repeated cesarean section with skin closure using staples.

Treatment:

Procedure: Staples

Tissue adhesive

Experimental group

Description:

Women who underwent repeated cesarean section with skin closure using 2-octylcyanoacrylate tissue adhesive.

Treatment:

Procedure: Tissue adhesive