Cesarean Section; InfectionNCT06119113

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

A study testing 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 Evaluation of the cosmetic results of the incision line at the 6th month post-op check-up among all groups in people with Cesarean Section; Infection and Scar, run by Ayşenur Çalış Özbayram at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cesarean Section; Infection, Scar
What is being tested?: 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 Evaluation of the cosmetic results of the incision line at the 6th month post-op check-up among all groups
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 22 Feb 2023to 22 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Başakşehir Çam Ve Sakura Şehir Hastanesi
Istanbul, Başakşehir, 00034

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the detailed description

Patients who met the inclusion criteria among patients who had a cesarean delivery (January 2023-June 2023) in our hospital within a 6-month period will be included in the study. Patients included in the study will be randomized and divided into three randomized groups as Vicryl (Polyglactin 910), Monocryl (Polyglecaprone 25) and Prolene (polypropylene) to be administered. Each cesarean section technique will be left to the discretion of the surgeon performing the operation, and cefazolin 2 g will be administered prophylactically half an hour before each procedure in our clinic. In all cases, a Pfannenstiel skin incision will be made 2 cm above the pubic symphysis. Following delivery of the fetus, the uterus, peritoneum, and fascia will be closed in sequence. The skin will be sealed with Vicryl (Polyglactin 910), Monocryl (Polyglecaprone 25), and Prolene (polypropylene) according to randomization. The dressing will be removed on the first day after the operation and the patients will be discharged on the second post-op day if there is no problem after the operation. Patients will be called for control on the 10th , 60th and 120th days of pos op. If the post op 10th day is deemed appropriate, the sutures of the patients in the prolene suture group will be removed. All groups that come to the control will be evaluated with the patient and the observer doctor by the patient and observer rating scale (POSAS) and the Vancouver Scar Scale (VSS).

The Patient and Observer Rating Scale (POSAS) is a questionnaire developed to assess scar quality. It consists of a five-observer and six-patient scale (Observer and Patient Scales) according to the rating scale based on clinically relevant scar characteristics [ Draaijers LJ, 2004 , Van de Kar AL, 2005]. Observer ; scores six items: vascularization, pigmentation, thickness, surface roughness, flexibility, and surface area. Patient ; it scores six items: pain, itching, color, thickness, relief and flexibility [Van de Kar AL , 2005]. All included items are scored on a multiple 10-point scale where 1 point is given when the wound feature is similar to 'normal skin' and 10 points are awarded when it reflects the 'worst scar'. All items are summed to determine the total scar score, with a higher score representing 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

Conditions: Cesarean Section; Infection, Scar
Being tested: 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, Evaluation of the cosmetic results of the incision line at the 6th month post-op check-up among all groups
Keywords: suture material, Caesarean section skin scar, Pfannenstiel
Medical subject headings: Infections, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evaluation of the wound infection at the 10th day post-op check-up among all groupsOther
Also called Post-op Control
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
Also called Post-op Control
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
Also called Post-op Control
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.

Study groups in NCT06119113
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of the 2nd month and 6th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 202322 Oct 2023

First posted7 Nov 2023
Study start22 Feb 2023
Primary completion22 Jul 2023
Study completion22 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cesarean Section; InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06119113
Sponsor's protocol ID: basaksehircamvesakurasehirh
Status last verified: Dec 2025
First submitted: 27 Sep 2023
Last updated: 18 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 32228099
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.
PubMed 20417924
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.
PubMed 28796687
Byrne M, Aly A. The Surgical Suture. Aesthet Surg J. 2019 Mar 14;39(Suppl_2):S67-S72. doi: 10.1093/asj/sjz036.
PubMed 30869751

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Microbial Colonization
Not yet recruitingObservational study
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
Enrolling by invitation
A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital
Surgical Site Infection (SSI)
Not yet recruiting
Intraperitoneal Saline Irrigation in Cesarean Section
Cesarean Section

All Cesarean Section; Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06119113
Acronym / sponsor ID: basaksehircamvesakurasehirh
Conditions: Cesarean Section; Infection, Scar
Keywords: suture material, Caesarean section skin scar, Pfannenstiel
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Ayşenur Çalış ÖzbayramOther government
Study start: 22 Feb 2023 (actual)
Primary completion: 22 Jul 2023 (actual)
Study completion: 22 Oct 2023 (actual)
First posted: 7 Nov 2023 (actual)
Results: Posted 18 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1 (Vicryl suture™(Polyglactin 910))	Active comparator	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 groupsThe group whose skin incision was closed with Vicryl suture™ (Polyglactin 910) from patients who had cesarean section for the first time
Group 2 (Prolene suture™(polypropylene))	Active comparator	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 groupsThe group whose skin incision was closed with Prolene suture™ (polypropylene) from patients who had cesarean section for the first time
Group 3 (Monocryl suture™ (Polyglecaprone 25))	Active comparator	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 groupsThe group whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) from patients who had cesarean section for the first time

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Evaluation of the wound infection at the 10th day post-op check-up among all groupsAlso: Post-op ControlDischarge, redness, increased temperature, and dehiscence were accepted as wound infection.	Other	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 groupsAlso: Post-op ControlThe 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.	Other	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 groupsAlso: Post-op ControlThe 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.	Other	Group 1 (Vicryl suture™(Polyglactin 910)), Group 2 (Prolene suture™(polypropylene)), Group 3 (Monocryl suture™ (Polyglecaprone 25))

Primary outcome

Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day
Time frame: 0-10. day
At the 10th postoperative day follow-up, discharge, redness, increased temperature and wound opening were considered as wound infection.
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
Time frame: End of the 2nd month and 6th month
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.
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
Time frame: End of the 2nd month and 6thmonth
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.
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
Time frame: End of the 2nd month and 6thmonth
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.
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)
Time frame: End of the 2nd month and 6th month
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.
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)
Time frame: End of the 2nd month and 6th month
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.
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)
Time frame: End of the 2nd month and 6th month
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.

Results and safety

Results posted to the registry on 18 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (Vicryl Suture™(Polyglactin 910))	100	85
Group 2 (Prolene Suture™(Polypropylene))	100	87
Group 3 (Monocryl Suture™ (Polyglecaprone 25))	100	79

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

Time frame: 0-10. day. Count of participants. Unit: Participants

Measure	Group 1 (Vicryl Suture™(Polyglactin 910)) n = 92	Group 2 (Prolene Suture™(Polypropylene)) n = 95	Group 3 (Monocryl Suture™ (Polyglecaprone 25)) n = 96
No wound infection	80	90	93
Wound infection	12	5	3

Population analysed: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously

Primary outcome: 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

Time frame: End of the 2nd month and 6th month. Mean (Standard Deviation). Unit: units on a scale

Measure	Group 1 (Vicryl Suture™(Polyglactin 910)) n = 85	Group 2 (Prolene Suture™(Polypropylene)) n = 87
POSAS 2nd month evaluation	26.9 (8.9)	20.5 (5.1)
POSAS 6th month evaluatıon	20.9 (6.1)	16.5 (3.9)

Population analysed: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously

Primary outcome: 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

Time frame: End of the 2nd month and 6thmonth. Mean (Standard Deviation). Unit: units on a scale

Measure	Group 1 (Vicryl Suture™(Polyglactin 910)) n = 85	Group 3 (Monocryl Suture™ (Polyglecaprone 25)) n = 79
POSAS 2nd month evaluatıon	26.9 (8.9)	18.7 (3.9)
POSAS 6th month evaluatıon	20.9 (6.1)	14.5 (2.4)

Population analysed: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously

Primary outcome: 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

Time frame: End of the 2nd month and 6thmonth. Mean (Standard Deviation). Unit: units on a scale

Measure	Group 2 (Prolene Suture™(Polypropylene)) n = 86	Group 3 (Monocryl Suture™ (Polyglecaprone 25)) n = 79
POSAS 2nd month evaluatıon	20.5 (5.1)	18.7 (3.9)
POSAS 6sh month evaluatıon	16.5 (3.9)	14.5 (2.4)

Population analysed: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (Vicryl Suture™(Polyglactin 910))	0 of 85 (0%)	12 of 85 (14.1%)	0 of 85
Group 2 (Prolene Suture™(Polypropylene))	0 of 87 (0%)	5 of 87 (5.7%)	0 of 87
Group 3 (Monocryl Suture™ (Polyglecaprone 25))	0 of 79 (0%)	2 of 79 (2.5%)	0 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32228099Koroglu 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.
Background: PubMed 20417924Cromi 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.
Results publication: PubMed 28796687Buresch 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.
Results publication: PubMed 30869751Byrne M, Aly A. The Surgical Suture. Aesthet Surg J. 2019 Mar 14;39(Suppl_2):S67-S72. doi: 10.1093/asj/sjz036.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ayşenur ÇALIŞ ÖZBAYRAM principal investigator

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1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day (time frame: 0-10. day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06119113, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.