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

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06119113
• Other study ID #: basaksehircamvesakurasehirh
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: Basaksehir Cam & Sakura Sehir Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section; Infection
• Communicable Diseases
• Infections
• Scar

Intervention

Other:
• Evaluation of the wound infection at the 10th day post-op check-up among all groups
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 groups
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 groups
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.

Locations

Country	Name	City	State
Turkey	Basaksehir Çam Ve Sakura Sehir Hastanesi	Istanbul	Basaksehir

Sponsors (1)

Lead Sponsor	Collaborator
Aysenur Çalis Özbayram

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Ekin M, Dagdeviren H, Caypinar SS, Erdogan B, Ayag ME, Cengiz H, Yasar L, Helvacioglu C. Comparative cosmetic outcome of surgical incisions created by the PEAK Plasma Blade and a scalpel after cesarean section by Patient and Observer Assessment Scale (POS — View Citation

Fleisher J, Khalifeh A, Pettker C, Berghella V, Dabbish N, Mackeen AD. Patient satisfaction and cosmetic outcome in a randomized study of cesarean skin closure. J Matern Fetal Neonatal Med. 2019 Nov;32(22):3830-3835. doi: 10.1080/14767058.2018.1474870. Ep — View Citation

Yang J, Kim KH, Song YJ, Kim SC, Sung N, Kim H, Lee DH. Cosmetic outcomes of cesarean section scar; subcuticular suture versus intradermal buried suture. Obstet Gynecol Sci. 2018 Jan;61(1):79-87. doi: 10.5468/ogs.2018.61.1.79. Epub 2018 Jan 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation for wound infection on the 10th post-operative day	Discharge, redness, increased temperature, and dehiscence were accepted as wound infection.	0-10. day
Primary	Evaluation of the incision cosmetic result at the 2nd month post-op	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.	2.month
Primary	Evaluation of the incision cosmetic result at the 6th month post-op	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.	6.month