Double Knots Versus Triple Knots Facia Closure Method; is There a Difference in Pain Sensation or Cosmetic Satisfaction?

NCT06303817 | Completed DMC

• 1 other identifier: 1812
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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; Pain; Cosmetics Sensitivity

Outcome Measures

Primary Outcomes (2)

• Change from baseline in pain on NRS (Numeric Rating Scale) at 10 days

  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."

  1. and 10. day

• Change from baseline in aesthetic results at 3 months

  . Patient satisfaction with the aesthetic results was assessed using a 10-point scale ranging from 1 (very unsatisfied) to 10 (very satisfied) at the 1st and 3rd months postoperatively. While scoring, patients were asked to score their scars by being reminded of parameters such as color, stiffness, thickness and irregularity. All patients were blinded to which technique was used for facial closure.

  1. day and 3. months

Study Arms (2)

Double knots group

OTHER

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.

Other: Double knots facia closure method during cesarean section

Triple knots group

OTHER

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.

Other: Triple knots facia closure method during cesarean section

Interventions

Double knots facia closure method during cesarean section OTHER

In Group I (double knots group), the edge of the fascia was identified with a Kocher clamp. A synthetic absorbable multifilament suture was used to close the fascia in a continuous fashion, starting from the opposite side up to the Kocher clamp. The knots were tied with the same single suture. I

Double knots group

Triple knots facia closure method during cesarean section OTHER

n Group II (triple knots group), the edge of the fascia was fixed with the same suture material instead of the Kocher clamp. The fascia was closed similarly, starting from the opposite corner via the second loop. The loops from the first suture were tied to the second suture.

Triple knots group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women who were scheduled for an elective or had an emergency cesarean section

You may not qualify if:

• 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
• Under 18 years old

Sponsors & Collaborators

• Adana City Training and Research Hospital: lead

Study Sites (1)

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, Yüreğir, 01120, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sevda Baş, M.D.

  Adana City Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)