Comparative Analysis of Subcuticular Suture Materials in Cesarean Section

NCT ID: NCT06543329

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-08-30

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.

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.

Conditions

Cesarean Wound Disruption With Postnatal Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

polyglactin 910

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

Group Type: ACTIVE_COMPARATOR

polyglactin 910

Intervention Type: PROCEDURE

75 PARTICIPANT, Vicryl suture was used in subcuticular suture

poliglecaprone 25

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

Group Type: ACTIVE_COMPARATOR

poliglecaprone 25

Intervention Type: PROCEDURE

75 PARTICIPANT, monocryl suture was used in subcuticular suture

polypropylene

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

Group Type: ACTIVE_COMPARATOR

polypropylene

Intervention Type: PROCEDURE

75 PARTICIPANT, Prolene suture was used in subcuticular suture

POLYESTER

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

Group Type: ACTIVE_COMPARATOR

polyester

Intervention Type: PROCEDURE

75 PARTICIPANT, Polyester suture was used in subcuticular suture

Interventions

polyglactin 910

75 PARTICIPANT, Vicryl suture was used in subcuticular suture

Intervention Type: PROCEDURE

poliglecaprone 25

75 PARTICIPANT, monocryl suture was used in subcuticular suture

Intervention Type: PROCEDURE

polypropylene

75 PARTICIPANT, Prolene suture was used in subcuticular suture

Intervention Type: PROCEDURE

polyester

75 PARTICIPANT, Polyester suture was used in subcuticular suture

Intervention Type: PROCEDURE

Other Intervention Names

VICRYL; monocryl; prolene; ETHIBOND EXCEL Suture

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

ahmed nagy shaker ramadan

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed N Afifi, MD

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

faculty of medicine, Kasr el ainy hospital, Cairo university

Cairo, , Egypt

Countries

Egypt

Central Contacts

Ahmed N Afifi, MD

Role: CONTACT

dr_nagy.ahmed@yahoo.com

01098670624

References

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Reference Type: BACKGROUND

PMID: 33451603 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20816153 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 9350017 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21195384 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21343772 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 24084548 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28796687 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23262925 (View on PubMed)

Other Identifiers

AA-2024-3

Identifier Type: -

Identifier Source: org_study_id