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

Cesarean Section Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839005
• Other study ID #: MRJ
• Status: Completed
• Phase: N/A
• First received: July 18, 2016
• Last updated: July 18, 2016
• Start date: April 2015

Study information

• Verified date: July 2016
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cesarean Section
• Sutures

Intervention

Other:
• Continuous suture with polyglecaprone 25
At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyglecaprone 25
• Continuous suture with polyamide (nylon)
At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyamide (nylon)

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas Samuel Libânio	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No