Interrupted Versus Continuous Subcuticular Skin Suturing in Elective Cesarean Section.

Comparative Study Between Interrupted and Continuous Subcuticular Skin Suturing in Women Undergoing Elective Cesarean Section. A Randomized Controlled Trial

Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who has their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who has their skin closed with subcuticular continous suture using the same suture material

Study Overview

• Status: Completed
• Conditions: Cesarean Section Wound
• Intervention / Treatment: Procedure: continuous subcuticular skin closure; Procedure: Interrupted subcuticular skin closure

Detailed Description

Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who had their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who had their skin closed with subcuticular continous suture using the same suture material.

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 18 years or older
• Overall good health
• Elective Cesarean section ASA class 1 or 2

Exclusion Criteria:

• Allergy to synthetic suture materials
• Diabetes whether gestational or pregestational
• use of steroid or immunosuppresive medication within last 6 month of procedure
• Skin sepsis or systemic fever
• BMI > 35
• History of keloid or hypertrophic scar formation or dermatologic conditions known to impair wound healing ASA class 3 or 4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: continous subcuticular; skin closed with continous subcuticular mattress suture using non-absorbable polypropylene	Procedure: continuous subcuticular skin closure; skin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section
Active Comparator: Interrupted subcuticular; skin closed with interrupted subcuticular mattress suture using non-absorbable polypropylene	Procedure: Interrupted subcuticular skin closure; skin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound infection	occurrence of signs of wound infection	10 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scar dehiscence	occurrence of scar dehiscence or incisional hernia	10 days after surgery
wound seroma	occurrence of seroma of wound	10 days after surgery
the need for reclosure	actual gapping of wound	10 days after surgery
postoperative pain	through visual analogue score The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.	12 hours after surgery
wound hematoma	occurrence of subcutanous hematoma	10 days after surgery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: April 16, 2017
• First Submitted That Met QC Criteria: April 16, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 12, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

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