nctId: NCT06303817 id: 1812 briefTitle: Double Knots Versus Triple Knots Facia Closure Method; is There a Difference in Pain Sensation or Cosmetic Satisfaction? overallStatus: COMPLETED date: 2022-03-01 date: 2022-06-01 date: 2023-01-01 date: 2024-03-12 date: 2024-03-12 name: Adana City Training and Research Hospital class: OTHER briefSummary: The study included women who were scheduled for an elective or had an emergency cesarean section. Age, body mass index (BMI), obstetric history, education status, smoking status and C-section indications of the patients were recorded. Patients with a previous suprapubic scar, medical conditions affecting wound healing (such as diabetes or chronic corticosteroid use), those needing a vertical incision (e.g., placenta previa), individuals with postoperative wound infection or under 18 years old were excluded. Data were collected in standardized data form by a research assistant. Pre- and post-surgery treatments and/or interventions were standardized. All patients received antimicrobial prophylaxis with cefazolin before the operation. The abdomen was entered via a transverse suprapubic skin incision and the surgical steps up to the point of facia closure were accomplished in a standard fashion. Technical differences such as blunt and sharp dissection, uterus exteriorization vs in situ, or parietal peritoneum closure were left to the surgeon's discretion. The procedures for facia closure are as follows; in Group I (Double knots group), the edge of the fascia was determined with a Kocher clamp. The fascia was closed starting from the opposite side with a synthetic absorbable multifilament suture in a continuous fashion up to the Kocher clamp and tied the knots with the same single suture (Figure 2; a-b). In Group II (Triple knots group), the edge of the fascia was fixed with the same suture material instead of the Kocher clamp, and the fascia was closed similarly, starting from the opposite corner via the second loop. Then the loops from the first suture were tied to the second suture (Figure 2; c-d). After the incision was irrigated with sterile saline solution, the subcutaneous space was closed if the thickness was 2 cm or more. Skin closure was accomplished with a subcuticular technique using a non-absorbable monofilament suture, which was removed on the 10th day postoperatively. A closed subcutaneous suction drain was not used in any of the patients. Postoperative pain at and around the incision line was measured on the 1st, and 10th days postoperatively on the NRS (Numeric Rating Scale), with "0" being "no pain" and "10" being "the worst pain imaginable." The 1st measurements were made face-to-face, and the 10th-day evaluation was made via telephone interviews by the same research assistant. conditions: Cesarean Section conditions: Pain conditions: Cosmetics Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 203 type: ACTUAL name: Double knots facia closure method during cesarean section name: Triple knots facia closure method during cesarean section measure: Change from baseline in pain on NRS (Numeric Rating Scale) at 10 days measure: Change from baseline in aesthetic results at 3 months sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Adana Şehir Eğitim ve Araştırma Hastanesi city: Adana state: Yüreğir zip: 01120 country: Turkey lat: 37.00167 lon: 35.32889 hasResults: False