Effect of Subcutaneous Tissue Closure on Wound Complications
The Effect of Subcutaneous Tissue Closure Technique in Cesarean Section on Reducing Postoperative Wound Complications
1 other identifier
interventional
400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 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
Study Start
First participant enrolled
June 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2017
CompletedFirst Posted
Study publicly available on registry
November 27, 2017
CompletedApril 5, 2022
April 1, 2022
5 months
November 19, 2017
April 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
interrupted sutures group
ACTIVE COMPARATORThis group in which closure of the subcutaneous layer is closed by interrupted sutures
Continous sutures group
ACTIVE COMPARATORsubcutanous tissue layer is closed by continous sutures in this group
Interventions
The way of closing subcutaneous tissue either by interrupted
The way of closure of subcutanous tissue is by continous sutures
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- The following patients were excluded BMI \<30, Previous CS, DM with pregnancy, HTN with pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Algazeerah
Giza, Egypt
Related Publications (1)
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.
PMID: 29415592DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mahmoud Alalfy, M.s.c
Algazeerah hospital -Location (Giza -Egypt )
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2017
First Posted
November 27, 2017
Study Start
June 18, 2017
Primary Completion
November 1, 2017
Study Completion
November 23, 2017
Last Updated
April 5, 2022
Record last verified: 2022-04