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

Cesarean Section Clinical Trial

Official title:

Cosmetic Outcomes After Skin Closure of Pfannenstiel Incision With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302597
• Other study ID #: GLUE-1
• Status: Completed
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: August 2021
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 15, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Procedure:
• Staples
Skin closure using surgical stapler.
• Tissue adhesive
Skin closure using 2-octylcyanoacrylate tissue adhesive.

Locations

Country	Name	City	State
Italy	Ospedale "Filippo Del Ponte"	Varese	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observer Scar Assessment Scale (OSAS) score	The Observer Scar Assessment Scale (OSAS) rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable uses a 10-point scoring system, with 1 representing normal skin. Ratings of individual variables may be summed to obtain a total score ranging from 5-50, with 5 representing normal skin.	6 months after repeated cesarean section
Secondary	Patient Scar Assessment Scale (PSAS) score	The Patient Scar Assessment Scale (PSAS) consists of 6 items on scar-related pain, itchiness, color, stiffness, thickness, and irregularity. Each item uses a 10-point scoring system, summed to obtain a total score ranging from 6-60, with 6 representing normal skin with no associated symptoms.	6 months after repeated cesarean section