CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Evaluation of the wound infection at the 10th day post-op check-up among all groups +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06119113
NCT06119113N/ACompleted

Evaluation of Wound Site Infection,Early and Late Wound Healing and Cosmetic Results of Vicryl ,Monocryl and Prolene Suture Materials Used in Pfannenstiel Skin Incision in Caesarean Section

Ayşenur Çalış Özbayram·interventional·Posted Nov 7, 2023·Updated Dec 18, 2025

In Brief

A clinical study evaluating Evaluation of the wound infection at the 10th day post-op check-up among all groups, Evaluation of the cosmetic results of the incision line at the 2nd month post-op check-up among all groups, and 1 other intervention for Cesarean Section; Infection and Scar. Completed, enrolled 300 participants across 1 site.

Detailed Summary

Our primary aim is to determine the most beneficial suture in order to reduce complications due to skin incision in common surgeries such as cesarean section, and our secondary aim is to evaluate the suture material used in terms of cosmetic results and participant preference.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedNov 7, 2023
Enrollment StartFeb 22, 2023
Primary CompletionJul 22, 2023
Study CompletionOct 22, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.7 years ago

Interventions

Evaluation of the wound infection at the 10th day post-op check-up among all groupsother

Discharge, redness, increased temperature, and dehiscence were accepted as wound infection.

Evaluation of the cosmetic results of the incision line at the 2nd month post-op check-up among all groupsother

The cosmetic outcome of wound site scar healing was evaluated with two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; A score of 1 is given when the scar characteristic is similar to 'normal skin' and a score of 10 is given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.

Evaluation of the cosmetic results of the incision line at the 6th month post-op check-up among all groupsother

The cosmetic outcome of wound site scar healing was evaluated with two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; A score of 1 is given when the scar characteristic is similar to 'normal skin' and a score of 10 is given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.