Effect of Subcutaneous Tissue Closure on Wound Complications

The Effect of Subcutaneous Tissue Closure Technique in Cesarean Section on Reducing Postoperative Wound Complications

Only a small number of research studies evaluated the impact of various subcutaneous tissue and skin closure methods at cesarean section. In a meta-analysis a major decline in incision site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous depth >2 cm.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Procedure: interrupted sutures; Procedure: continous sutures

Detailed Description

Postoperative wound complications are one of the great issues in cesarean section (CS) with an incidence ranging from 3% to 30%.1 Obesity, operative time, diabetes, age of the patient, anemia, associated infection (e.g chorioamnionitis), the use of internal monitoring, delayed labor with many vaginal examinations and reduced nutrition are recognized risk factors for wound infections.

Evaluating the various techniques for closure of the subcutaneous layer.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Algazeerah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All patients included in this research BMI ≥ 30, First cesarean section performed, no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.

depth of subcutaneous tissue estimated by a special device used (sterilized operative ruler). number of sutures estimation

Exclusion Criteria:

• The following patients were excluded BMI <30, Previous CS, DM with pregnancy, HTN with pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: interrupted sutures group; This group in which closure of the subcutaneous layer is closed by interrupted sutures	Procedure: interrupted sutures; The way of closing subcutaneous tissue either by interrupted; Procedure: continous sutures; The way of closure of subcutanous tissue is by continous sutures
Active Comparator: Continous sutures group; subcutanous tissue layer is closed by continous sutures in this group	Procedure: interrupted sutures; The way of closing subcutaneous tissue either by interrupted; Procedure: continous sutures; The way of closure of subcutanous tissue is by continous sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants who passed without postoperative complications	Describes how many participant willnot complain from wound seroma , wound erythema and wound infection	one month post cesarean section

Collaborators and Investigators

• Sponsor: Aljazeera Hospital

Publications and helpful links

General Publications

• Alalfy M, Elgazzar A, Fares T, Nagy O, Ellithy A, Lasheen Y, Kamel A, Soliman M, Hassan A, Samy A, Taher AM, Ogila AI, Saad H, Salah H, Ramadan M, Nabil M, Hatem DL, Fikry M. Effect of subcutaneous tissue closure technique in cesarean section on postoperative wound complications in obese Egyptian women. J Matern Fetal Neonatal Med. 2019 Aug;32(15):2452-2459. doi: 10.1080/14767058.2018.1438399. Epub 2018 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2017
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 23, 2017

Study Registration Dates

• First Submitted: November 19, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Cesarean section; Wound infection; Gapping
• Other Study ID Numbers: Cesarean section / sutures

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No