Comparative Analysis of Subcuticular Suture Materials in Cesarean Section

August 6, 2024 updated by: ahmed nagy shaker ramadan, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

3. 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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • faculty of medicine, Kasr el ainy hospital, Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: polyglactin 910
- Group A: (75) women with subcuticular suture polyglactin 910, braided, (VICRYL RAPIDE®; Ethicon) was used in subcuticular skin closure.
Procedure: polyglactin 910
75 PARTICIPANT, Vicryl suture was used in subcuticular suture
Other Names:
  • VICRYL
Active Comparator: poliglecaprone 25
Group A: (75) women with subcuticular suture poliglecaprone 25, (MONOCRYL) was used in subcuticular skin closure.
Procedure: poliglecaprone 25
75 PARTICIPANT, monocryl suture was used in subcuticular suture
Other Names:
  • monocryl
Active Comparator: polypropylene
Group A: (75) women with subcuticular suture polypropylene, (PROLENE) was used in subcuticular skin closure.
Procedure: polypropylene
75 PARTICIPANT, Prolene suture was used in subcuticular suture
Other Names:
  • prolene
Active Comparator: POLYESTER
Group A: (75) women with subcuticular suture POLYESTER, (ETHIBOND EXCEL Suture) was used in subcuticular skin closure.
Procedure: polyester
75 PARTICIPANT, Polyester suture was used in subcuticular suture
Other Names:
  • ETHIBOND EXCEL Suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Kafrelsheikh University

Investigators

  • Principal Investigator: Ahmed N Afifi, MD, Kafrelsheikh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

July 27, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA-2024-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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