Cesarean Section Clinical Trial
NCT number | NCT02839005 |
Other study ID # | MRJ |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | July 18, 2016 |
Last updated | July 18, 2016 |
Start date | April 2015 |
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 |
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
Status | Completed |
Enrollment | 60 |
Est. completion date | |
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 . |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas Samuel Libânio | Pouso Alegre | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Universidade do Vale do Sapucai |
Brazil,
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 |
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