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N/A N=300 Randomized Prevention

Evaluation of Wound Infection Rates and Cosmetic Results of Different Suture Materials in Cesarean Skin Incision

Cesarean Section; Infection · Scar

Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day — 80; 90; 93; 12 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Evaluation of the wound infection at the 10th day post-op check-up among all groups (Other); Evaluation of the cosmetic results of the incision line at the 2nd month post-op check-up among all groups (Other); Evaluation of the cosmetic results of the incision line at the 6th month post-op check-up among all groups (Other)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Ayşenur Çalış Özbayram
Primary completion
Jul 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day
80; 90; 93; 12; 5; 3
PRIMARY
Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 2 (Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS
26.9; 20.5; 20.9; 16.5
PRIMARY
Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS
26.9; 18.7; 20.9; 14.5
PRIMARY
Comparison of Incision Cosmetic Results Between Group 2 (Prolene Suture™(Polypropylene)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS
20.5; 18.7; 16.5; 14.5
PRIMARY
Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 2(Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale (VSS)
4; 3; 3; 3
PRIMARY
Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS)
4; 3; 3; 2
PRIMARY
Comparison of Incision Cosmetic Results Between Group 2(Prolene Suture™(Polypropylene)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS)
3; 3; 3; 2

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.

Eligibility Criteria

Inclusion Criteria

  • 18-45 years old
  • Patients who had a primary cesarean section at our >37w hospital
  • Patients with a Pfannenstiel incision closed subcutaneously

Exclusion Criteria

  • Women <18 years and >45 years old
  • Those with a history of keloid
  • Suprapubic incision due to previous surgery
  • Signs of infection at or near the incision during cesarean section
  • Known hypersensitivity to any of the suture materials used
  • Having a medical condition that causes immunosuppression, such as DM, chronic corticosteroid use
  • Failure to obtain informed consent from the patient
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06119113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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