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

NCT ID: NCT02839005

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30

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

Conditions

Cesarean Section; Sutures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

suture with polyglecaprone 25

Group Type: ACTIVE_COMPARATOR

Continuous suture with polyglecaprone 25

Intervention Type: OTHER

At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyglecaprone 25

suture with polyamide (nylon)

Group Type: ACTIVE_COMPARATOR

Continuous suture with polyamide (nylon)

Intervention Type: OTHER

At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyamide (nylon)

Interventions

Continuous suture with polyglecaprone 25

At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyglecaprone 25

Intervention Type: OTHER

Continuous suture with polyamide (nylon)

At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyamide (nylon)

Intervention Type: OTHER

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Vale do Sapucai

OTHER

Sponsor Role: lead

Responsible Party

Roberta Junqueira Lima

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital das Clínicas Samuel Libânio

Pouso Alegre, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

MRJ

Identifier Type: -

Identifier Source: org_study_id