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
1 other identifier
interventional
169
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2017
CompletedStudy Start
First participant enrolled
April 16, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2017
CompletedDecember 23, 2021
December 1, 2021
8 months
April 16, 2017
December 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
wound infection
occurrence of signs of wound infection
10 days after surgery
Secondary Outcomes (5)
scar dehiscence
10 days after surgery
wound seroma
10 days after surgery
the need for reclosure
10 days after surgery
postoperative pain
12 hours after surgery
wound hematoma
10 days after surgery
Study Arms (2)
continous subcuticular
ACTIVE COMPARATORskin closed with continous subcuticular mattress suture using non-absorbable polypropylene
Interrupted subcuticular
ACTIVE COMPARATORskin closed with interrupted subcuticular mattress suture using non-absorbable polypropylene
Interventions
skin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section
skin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section
Eligibility Criteria
You may qualify if:
- years or older
- Overall good health
- Elective Cesarean section ASA class 1 or 2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alainy medical school
Cairo, 12151, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Maged, MD
Kasr Alainy medical school
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 16, 2017
First Posted
April 19, 2017
Study Start
April 16, 2017
Primary Completion
December 1, 2017
Study Completion
December 20, 2017
Last Updated
December 23, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share