Effect of Subcutaneous Tissue Closure on Wound Complications

• Sponsor: Aljazeera Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03354078
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.2
• Patients Per Site Per Month: 77.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Procedure: interrupted sutures; Procedure: continous sutures	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: The Effect of Subcutaneous Tissue Closure Technique in Cesarean Section on Reducing Postoperative Wound Complications
• Actual Study Start Date: Jun 18, 2017
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Nov 23, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The number of participants who passed without postoperative complications [one month post cesarean section]

   Describes how many participant willnot complain from wound seroma , wound erythema and wound infection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Algazeerah	Giza		Egypt

Sponsors and Collaborators

• Aljazeera Hospital

Investigators

• Study Chair: Mahmoud Alalfy, M.s.c, Algazeerah hospital -Location (Giza -Egypt )

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aljazeera Hospital
• ClinicalTrials.gov Identifier: NCT03354078
• Other Study ID Numbers: Cesarean section / sutures
• First Posted: Nov 27, 2017
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aljazeera Hospital: Cesarean section; Wound infection; Gapping

Study Results

No Results Posted as of Apr 5, 2022