NCT04302597

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
PROCEDURE	Staples	Skin closure using surgical stapler.
PROCEDURE	Tissue adhesive	Skin closure using 2-octylcyanoacrylate tissue adhesive.

Timeline

• Start date: 2020-05-15
• Primary completion: 2021-01-30
• Completion: 2021-07-15
• First posted: 2020-03-10
• Last updated: 2021-09-08

Locations

1 site across 1 country: Italy