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OpenTrials
Completed

NCT Number: NCT02839005

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas Samuel Libânio

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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

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)

Primary outcomes

  1. Photographic documentation for evaluation

    Time frame: 6 Months

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

  2. Photographic documentation for evaluation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidade do Vale do Sapucai

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Jul 20, 2016
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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