Absorbable Suture Versus Nonabsorbable Suture Intradermal for the Skin Transverse Section in Cesarean

Not Applicable

Completed

• Conditions: Cesarean Section; Sutures
• Interventions: Other: Continuous suture with polyamide (nylon); Other: Continuous suture with polyglecaprone 25

• Registration Number: NCT02839005
• Lead Sponsor: Universidade do Vale do Sapucai

Brief Summary

Context: Cesarean section is the most common surgery in women, both in developed and underdeveloped countries. However results are conflicting report in which material for intradermal suturing get better aesthetic result. Objective: To compare the aesthetic appearance of two suture materials, polyglecaprone 25 and polyamide (nylon) with intradermal sutures for skin closure in women undergoing cesarean section first. Methods: This is a clinical, prospective and randomized study which was conducted in the Department of Gynecology and Obstetrics of a tertiary Institute, Hospital das Clinicas Samuel Libânio, in PousoAlegre, Estate of Minas Gerais. Sixty women undergoing cesarean section were first included and randomized into two groups: group I (n = 30) polyamide and group II (n = 30) polyglecaprone 25. Hypertrophy, color and width of the wound were evaluated, receiving a score, according to Trimbos table, six months after surgery. Later the results were compared to non-parametric statistical tests

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2016-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Last Update Submitted: 2016-07-18
• Study First Posted: 2016-07-20
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Patients who underwent cesarean section
• No restriction of ethnicity, education or social class

Exclusion Criteria

• Scarring Pfannenstiel prior
• Diabetic patients using drugs;
• Patients with collagen diseases
• Patients with pre operative tests to indicate any systemic sign of infection or site, not previously treated until the time of surgery.
• Patients who withdrew informed consent
• Patients who did not attend the pre scheduled dates for the controls after surgery .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
suture with polyamide (nylon)	Continuous suture with polyamide (nylon)	-
suture with polyglecaprone 25	Continuous suture with polyglecaprone 25	-

Primary Outcome Measures

Name	Time	Method
Photographic documentation for evaluation	6 Months	The photographic record was sent to another expert for evaluation of hypertrophy and cross marks staining points, according Trimboset al.,1993, besides scar mesure

Trial Locations

Locations (1)

Hospital das Clínicas Samuel Libânio; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil