Clinical trial NCT04302597: Cosmetic Outcomes With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section
Official title: Cosmetic Outcomes After Skin Closure of Pfannenstiel Incision With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean delivery
Cosmesis
Healing
Skin closure
Scar assessment scales
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective, randomized controlled trial
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Observer Scar Assessment Scale (OSAS) score
timeFrame: 6 months after repeated cesarean section
Secondary outcomes:
measure: Patient Scar Assessment Scale (PSAS) score
timeFrame: 6 months after repeated cesarean section
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Ospedale "Filippo Del Ponte"
state: Lombardia
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonella Cromi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Fabio Ghezzi, M.D.
role: STUDY_CHAIR
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D., Ph.D.
role: STUDY_CHAIR
References: