Clinical trial NCT06119113: Wound Infection Due to Suture Material in Caesarean Skin Incision and Evaluation of Cosmetic Results
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Infection
Scar
Keywords: suture material
Caesarean section skin scar
Pfannenstiel
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Women \&lt;18 years and \&gt;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

Primary outcomes:
measure: Evaluation for wound infection on the 10th post-operative day
timeFrame: 0-10. day
measure: Evaluation of the incision cosmetic result at the 2nd month post-op
timeFrame: 2.month
measure: Evaluation of the incision cosmetic result at the 6th month post-op
timeFrame: 6.month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Başakşehir Çam Ve Sakura Şehir Hastanesi
state: Başakşehir
Study officials:
References:
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.
citation: 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 (POSAS): A randomized double blind study. Taiwan J Obstet Gynecol. 2018 Feb;57(1):68-70. doi: 10.1016/j.tjog.2017.12.011.
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. Epub 2018 May 24.