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NCT Number: NCT06543329

Comparative Analysis of Subcuticular Suture Materials in Cesarean Section

1.1. Background and Rationale Cesarean section is one of the most common surgical procedures performed worldwide. The choice of suture material for closing the skin incision is crucial, as it can influence wound healing, the risk of wound complications, and the cosmetic outcome. Subcuticular suturing, a technique where the suture is placed just under the skin, is favored for its aesthetic benefits and reduced risk of infection. However, the type of suture material used can significantly impact these outcomes. This study aims to provide a comparative analysis of various subcuticular suture materials used in cesarean sections, focusing on wound complications and incision outcomes.

1.2. Objective of the Study The objective of this study is to compare the incidence of wound complications and the quality of incision outcomes associated with different subcuticular suture materials used in cesarean sections. By doing so, the investigators aim to identify the most effective suture material for minimizing wound complications and optimizing cosmetic results.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine, Kasr el ainy hospital, Cairo university

Cairo, 11562, Egypt

About this study

2.1. Surgical Techniques in Cesarean Section Cesarean section involves multiple surgical steps, including skin incision, uterine incision, and closure of the incisions. The subcuticular suturing technique is often preferred for skin closure due to its potential for better cosmetic results and lower infection rates compared to other methods like staples or interrupted sutures.

2.2. Types of Suture Materials

Suture materials can be broadly categorized into absorbable and non-absorbable, and further into monofilament and multifilament types. Common suture materials used in subcuticular skin closure include:

Absorbable Sutures: Poliglecaprone (Monocryl), Polyglactin (Vicryl), Polydioxanone (PDS).

Non-Absorbable Sutures: Nylon, Polypropylene (Prolene), Silk. 2.3. Previous Studies on Suture Materials in Cesarean Section Previous studies have explored the impact of different suture materials on wound healing, infection rates, and cosmetic outcomes. Research indicates varying results, with some studies favoring absorbable sutures for their reduced need for removal and lower infection rates, while others suggest non-absorbable sutures may provide stronger wound support. However, comprehensive comparative analyses specific to cesarean sections remain limited.

  • Methodology 3.1. Study Design This study will use a prospective, randomized controlled trial design. Participants undergoing elective cesarean sections will be randomly assigned to receive subcuticular suturing with one of several suture materials.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 20-45 years old.
  • BMI = or more than 40 kg/m2
  • Primigravida or not more than the previous 1 cesarean section.
  • Will undergo a lower-segment cesarean section.
  • Hb: ≥ 10 gm/dl.
  • Viable fetus.
  • No history of medical comorbidities.

Exclusion criteria

  • History of urogenital tract infection within 2 weeks before cesarean delivery.
  • Presence of clinical signs of infection at the time of delivery including PPROM and intraamniotic infection.
  • Medical comorbidities (hypertension, diabetes, etc.).
  • Hypersensitivity to any of the suture materials.
  • Women with abnormal placentation (placental abruption or placenta previa).
  • History of systemic corticosteroid intake during their pregnancy for 2 weeks or more.
  • History of previous surgical site infection.
  • Immune-compromised women.
  • Women refused to participate in the study or could not obtain consent.

Treatment and study plan

polyglactin 910

Procedure

75 PARTICIPANT, Vicryl suture was used in subcuticular suture

Other names: VICRYL

poliglecaprone 25

Procedure

75 PARTICIPANT, monocryl suture was used in subcuticular suture

Other names: monocryl

polypropylene

Procedure

75 PARTICIPANT, Prolene suture was used in subcuticular suture

Other names: prolene

polyester

Procedure

75 PARTICIPANT, Polyester suture was used in subcuticular suture

Other names: ETHIBOND EXCEL Suture

Primary outcomes

  1. the rate of any documented wound complication during the first six weeks postpartum

    Time frame: 6 weeks

    This measure tracks the incidence of wound complications within six weeks postpartum, including infection, dehiscence, seroma, hematoma, ecchymosis, pus, delayed healing, and secondary suture needs.

    Measurement Tools:

    Clinical examinations during follow-up visits Patient self-reports Review of medical records

    Assessment Procedure:

    Patients will undergo follow-up visits at 2, 4, and 6 weeks postpartum. Complications will be documented through clinical exams, patient reports, and medical record reviews.

    Calculation:

    The rate is calculated as the number of patients with any wound complication divided by the total number of patients, expressed as a percentage.

Secondary outcomes

  1. cosmetics satisfaction

    Time frame: 6 weeks

    This measure assesses the cosmetic appearance of surgical wounds post-abdominal myomectomy.

    Measurement Tool:

    A standardized cosmetic appearance scale will be used, such as the Patient and Observer Scar Assessment Scale (POSAS).

    Assessment Procedure:

    Evaluations will be conducted at follow-up visits (2, 4, and 6 weeks postpartum) by both the patient and a clinician.

    Parameters Assessed:

    Scar color, texture, and overall appearance Patient satisfaction with the cosmetic outcome

    Calculation:

    Scores from the POSAS will be averaged to determine the overall cosmetic appearance rating.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed N Afifi, MD

CONTACT

[email protected]

01098670624

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Kafrelsheikh University

Registry information

Official study title

Comparative Analysis Between Different Suture Materials in Subcuticular Cesarean Wound Closure in Woman With BMI 40 or Greater in Cesarean Delivery: An Interventional Randomized Comparative Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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