Wound Infection Due to Suture Material in Caesarean Skin Incision and Evaluation of Cosmetic Results

Not Applicable

Completed

• Conditions: Cesarean Section; Infection; Scar
• Interventions: 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

• Registration Number: NCT06119113
• Lead Sponsor: Ayşenur Çalış Özbayram

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.

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

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-01
• Study First Submitted: 2023-09-27
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3 (Monocryl suture™ (Polyglecaprone 25))	Evaluation of the wound infection at the 10th day post-op check-up among all groups	The group whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) from patients who had cesarean section for the first time
Group 1 (Vicryl suture™(Polyglactin 910))	Evaluation of the wound infection at the 10th day post-op check-up among all groups	The group whose skin incision was closed with Vicryl suture™ (Polyglactin 910) from patients who had cesarean section for the first time
Group 1 (Vicryl suture™(Polyglactin 910))	Evaluation of the cosmetic results of the incision line at the 6th month post-op check-up among all groups	The 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))	Evaluation of the cosmetic results of the incision line at the 6th month post-op check-up among all groups	The group whose skin incision was closed with Prolene suture™ (polypropylene) from patients who had cesarean section for the first time
Group 1 (Vicryl suture™(Polyglactin 910))	Evaluation of the cosmetic results of the incision line at the 2nd month post-op check-up among all groups	The group whose skin incision was closed with Vicryl suture™ (Polyglactin 910) from patients who had cesarean section for the first time
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	The group whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) from patients who had cesarean section for the first time
Group 2 (Prolene suture™(polypropylene))	Evaluation of the cosmetic results of the incision line at the 2nd month post-op check-up among all groups	The 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))	Evaluation of the cosmetic results of the incision line at the 2nd month post-op check-up among all groups	The group whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) from patients who had cesarean section for the first time
Group 2 (Prolene suture™(polypropylene))	Evaluation of the wound infection at the 10th day post-op check-up among all groups	The group whose skin incision was closed with Prolene suture™ (polypropylene) from patients who had cesarean section for the first time

Primary Outcome Measures

Name	Time	Method
Evaluation of the incision cosmetic result at the 6th month post-op	6.month	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 for wound infection on the 10th post-operative day	0-10. day	Discharge, redness, increased temperature, and dehiscence were accepted as wound infection.
Evaluation of the incision cosmetic result at the 2nd month post-op	2.month	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.

Trial Locations

Locations (1)

Başakşehir Çam Ve Sakura Şehir Hastanesi; 🇹🇷 Istanbul, Başakşehir, Turkey