Status:
COMPLETED
Cosmetic Outcomes With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section
Lead Sponsor:
Università degli Studi dell'Insubria
Conditions:
Cesarean Section
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
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 clini...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04302597
Start Date
May 15 2020
End Date
July 15 2021
Last Update
September 8 2021
Active Locations (1)
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1
Ospedale "Filippo Del Ponte"
Varese, Lombardy, Italy, 21100