Comparative Analysis of Subcuticular Suture Materials in Cesarean Section

NCT06543329 | Not Yet Recruiting

• 1 other identifier: AA-2024-3
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Wound Disruption With Postnatal Complication

Keywords

cesarean section; wound complication; obesity; monocryl; vicryl; prolene; polyester

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• cosmetics satisfaction

  6 weeks

Study Arms (4)

polyglactin 910

ACTIVE COMPARATOR

\- Group A: (75) women with subcuticular suture polyglactin 910, braided, (VICRYL RAPIDE®; Ethicon) was used in subcuticular skin closure.

Procedure: polyglactin 910

poliglecaprone 25

ACTIVE COMPARATOR

Group A: (75) women with subcuticular suture poliglecaprone 25, (MONOCRYL) was used in subcuticular skin closure.

Procedure: poliglecaprone 25

polypropylene

ACTIVE COMPARATOR

Group A: (75) women with subcuticular suture polypropylene, (PROLENE) was used in subcuticular skin closure.

Procedure: polypropylene

POLYESTER

ACTIVE COMPARATOR

Group A: (75) women with subcuticular suture POLYESTER, (ETHIBOND EXCEL Suture) was used in subcuticular skin closure.

Procedure: polyester

Interventions

polyglactin 910 PROCEDURE

75 PARTICIPANT, Vicryl suture was used in subcuticular suture

Also known as: VICRYL

polyglactin 910

poliglecaprone 25 PROCEDURE

75 PARTICIPANT, monocryl suture was used in subcuticular suture

Also known as: monocryl

poliglecaprone 25

polypropylene PROCEDURE

75 PARTICIPANT, Prolene suture was used in subcuticular suture

Also known as: prolene

polypropylene

polyester PROCEDURE

75 PARTICIPANT, Polyester suture was used in subcuticular suture

Also known as: ETHIBOND EXCEL Suture

POLYESTER

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: This prospective interventional randomized comparative clinical trial was carried out on 300 pregnant women scheduled for elective caesarean section at operative theater
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Kafrelsheikh University: collaborator

Study Sites (1)

faculty of medicine, Kasr el ainy hospital, Cairo university

Cairo, 11562, Egypt

Location

Related Publications (9)

• Rodel RL, Gray KM, Quiner TE, Bodea Braescu A, Gerkin R, Perlow JH. Cesarean wound closure in body mass index 40 or greater comparing suture to staples: a randomized clinical trial. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100271. doi: 10.1016/j.ajogmf.2020.100271. Epub 2020 Oct 27.

  PMID: 33451603 BACKGROUND

• Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011.

  PMID: 20816153 BACKGROUND

• Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.

  PMID: 9350017 BACKGROUND

• Clay FS, Walsh CA, Walsh SR. Staples vs subcuticular sutures for skin closure at cesarean delivery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2011 May;204(5):378-83. doi: 10.1016/j.ajog.2010.11.018. Epub 2010 Dec 31.

  PMID: 21195384 BACKGROUND

• Tuuli MG, Rampersad RM, Carbone JF, Stamilio D, Macones GA, Odibo AO. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2011 Mar;117(3):682-690. doi: 10.1097/AOG.0b013e31820ad61e.

  PMID: 21343772 BACKGROUND

• Nayak G B, Saha PK, Bagga R, Joshi B, Rohilla M, Gainder S, Sikka P. Wound complication among different skin closure techniques in the emergency cesarean section: a randomized control trial. Obstet Gynecol Sci. 2020 Jan;63(1):27-34. doi: 10.5468/ogs.2020.63.1.27. Epub 2019 Dec 23.

  PMID: 31970125 BACKGROUND

• Aabakke AJM, Krebs L, Pipper CB, Secher NJ. Subcuticular suture compared with staples for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):878-884. doi: 10.1097/AOG.0b013e3182a5f0c3.

  PMID: 24084548 BACKGROUND

• Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.

  PMID: 28796687 BACKGROUND

• Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.

  PMID: 23262925 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Polyglactin 910; glycolide E-caprolactone copolymer; Polypropylenes; Polyesters

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Plastics

Study Officials

• Ahmed N Afifi, MD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed N Afifi, MD

CONTACT

01098670624; dr_nagy.ahmed@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: This prospective interventional randomized comparative clinical trial was carried out on 300 pregnant women scheduled for elective caesarean section at operative theater

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 30, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

EG (1)