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CompletedNCT02839005Updated Jul 20, 2016

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

An interventional study of Continuous suture with polyglecaprone 25 and Continuous suture with polyamide (nylon) in Cesarean Section and Sutures, sponsored by Universidade do Vale do Sapucai. Completed at 1 site in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-20.

Sponsored by Universidade do Vale do Sapucai · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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

02

Conditions studied

  • Cesarean Section
  • Sutures

Keywords

  • Wound Closure Thechnical
  • Wound Healing
03

In context

Lead sponsor

Universidade do Vale do Sapucai is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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 .
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    suture with polyglecaprone 25

    Other: Continuous suture with polyglecaprone 25

  • Active comparator
    suture with polyamide (nylon)

    Other: Continuous suture with polyamide (nylon)

Interventions

  • OtherContinuous suture with polyglecaprone 25

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

  • OtherContinuous suture with polyamide (nylon)

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 Months

  2. 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

    Time frame: 6 Months

07

Study locations

1 site
  • Hospital das Clínicas Samuel Libânio
    Pouso Alegre, Minas Gerais 37550-000, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02839005
Lead sponsor
Universidade do Vale do Sapucai
Responsible party
Roberta Junqueira Lima (MD, Universidade do Vale do Sapucai) — Principal investigator
First posted
Jul 20, 2016
Start date
Apr 2015
Primary completion
Jan 2016
Last update
Jul 20, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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