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

NCT06119113 | Completed Results

• 1 other identifier: basaksehircamvesakurasehirh
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section; Infection; Scar

Keywords

suture material; Caesarean section skin scar; Pfannenstiel

Outcome Measures

Primary Outcomes (7)

• Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day

  At the 10th postoperative day follow-up, discharge, redness, increased temperature and wound opening were considered as wound infection.

  0-10. day

• 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

  The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.

  End of the 2nd month and 6th month

• 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

  The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.

  End of the 2nd month and 6thmonth

• 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

  The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.

  End of the 2nd month and 6thmonth

• 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)

  The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.

  End of the 2nd month and 6th month

• 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)

  The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.

  End of the 2nd month and 6th month

• 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)

  The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.

  End of the 2nd month and 6th month

Study Arms (3)

Group 1 (Vicryl suture™(Polyglactin 910))

ACTIVE COMPARATOR

The group whose skin incision was closed with Vicryl suture™ (Polyglactin 910) from patients who had cesarean section for the first time

Other: 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

Group 2 (Prolene suture™(polypropylene))

ACTIVE COMPARATOR

The group whose skin incision was closed with Prolene suture™ (polypropylene) from patients who had cesarean section for the first time

Other: 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

Group 3 (Monocryl suture™ (Polyglecaprone 25))

ACTIVE COMPARATOR

The group whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) from patients who had cesarean section for the first time

Other: 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

Interventions

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

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

Also known as: Post-op Control

Group 1 (Vicryl suture™(Polyglactin 910)); Group 2 (Prolene suture™(polypropylene)); Group 3 (Monocryl suture™ (Polyglecaprone 25))

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

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.

Also known as: Post-op Control

Group 1 (Vicryl suture™(Polyglactin 910)); Group 2 (Prolene suture™(polypropylene)); Group 3 (Monocryl suture™ (Polyglecaprone 25))

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

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.

Also known as: Post-op Control

Group 1 (Vicryl suture™(Polyglactin 910)); Group 2 (Prolene suture™(polypropylene)); Group 3 (Monocryl suture™ (Polyglecaprone 25))

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayşenur Çalış Özbayram: lead

Study Sites (1)

Başakşehir Çam Ve Sakura Şehir Hastanesi

Istanbul, Başakşehir, 00034, Turkey (Türkiye)

Location

Related Publications (4)

• Koroglu N, Temel Yuksel I, Aslan Cetin B, Aytufan Z, Deniz N, Akca A, Yetkin Yildirim G, Yuksel A. Skin closure at cesarean section, polypropylene versus polyglactin 910: a randomized controlled study. J Matern Fetal Neonatal Med. 2022 Mar;35(6):1088-1092. doi: 10.1080/14767058.2020.1743654. Epub 2020 Mar 30.

  PMID: 32228099 BACKGROUND

• Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.

  PMID: 20417924 BACKGROUND

• Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.

  PMID: 28796687 RESULT

• Byrne M, Aly A. The Surgical Suture. Aesthet Surg J. 2019 Mar 14;39(Suppl_2):S67-S72. doi: 10.1093/asj/sjz036.

  PMID: 30869751 RESULT

MeSH Terms

Conditions

Infections; Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr.Ayşenur Çalış Özbayram
• Organization: Başakşehir Çam Ve Sakura Şehir Hastanesi

draysenurcalis@gmail.com

+905549707052

Study Officials

• Ayşenur ÇALIŞ ÖZBAYRAM

  yok

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gynecology And Obstetrics Doctor

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: November 7, 2023
• Study Start: February 22, 2023
• Primary Completion: July 22, 2023
• Study Completion: October 22, 2023
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-12

Locations

TU (1)