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

NCT02839005 | Completed

• 1 other identifier: MRJ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Wound Closure Thechnical; Wound Healing

Outcome Measures

Primary Outcomes (2)

• Photographic documentation for evaluation

  The photographic record was sent to three experts for evaluation of hypertrophy and cross marks staining points, according Trimboset al.,1993

  6 Months

• Photographic documentation for evaluation

  The photographic record was sent to another expert for evaluation of hypertrophy and cross marks staining points, according Trimboset al.,1993, besides scar mesure

  6 Months

Study Arms (2)

suture with polyglecaprone 25

ACTIVE COMPARATOR

Other: Continuous suture with polyglecaprone 25

suture with polyamide (nylon)

ACTIVE COMPARATOR

Other: Continuous suture with polyamide (nylon)

Interventions

Continuous suture with polyglecaprone 25 OTHER

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

suture with polyglecaprone 25

Continuous suture with polyamide (nylon) OTHER

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

suture with polyamide (nylon)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Hospital das Clínicas Samuel Libânio

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

MeSH Terms

Interventions

glycolide E-caprolactone copolymer; Nylons

Intervention Hierarchy (Ancestors)

Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

BR (1)