Clinical trial NCT06543329: Comparative Analysis of Subcuticular Suture Materials in Cesarean Section
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Wound Disruption With Postnatal Complication
Keywords: cesarean section
wound complication
obesity
monocryl
vicryl
prolene
polyester
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Kafrelsheikh University
First posted: 2024-08-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective interventional randomized comparative clinical trial was carried out on 300 pregnant women scheduled for elective caesarean section at operative theater
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: the rate of any documented wound complication during the first six weeks postpartum
timeFrame: 6 weeks
Secondary outcomes:
measure: cosmetics satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine, Kasr el ainy hospital, Cairo university
Study officials:
affiliation: Kafrelsheikh University
name: Ahmed N Afifi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.