Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04220294
• Collaborator: (none)
• Enrollment: 1,450
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 50

Study Details

Study Description

Brief Summary

A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted.

Condition or Disease	Intervention/Treatment	Phase
Suture Line Infection	Procedure: Subcutaneous tissue closure	N/A

Detailed Description

Patients at term that are candidates for elective cesarean section or patients undergoing emergent cesarean section will receive an explanation regarding the study and sign informed consent. Patients will then be divided randomly to one of 2 treatment groups based on the type of subcutaneous tissue closure:

1. Interrupted sutures.

2. Continuous sutures. Information regarding medical and obstetric history will be collected for each patient.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Surgical Site Infection Rate After Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
• Actual Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interrupted sutures Subcutaneous tissue closure by interrupted sutures.	Procedure: Subcutaneous tissue closure; Subcutaneous tissue closure with 2-0 vicryl suture.
Active Comparator: Continuous sutures Subcutaneous tissue closure by continuous sutures.	Procedure: Subcutaneous tissue closure; Subcutaneous tissue closure with 2-0 vicryl suture.

Outcome Measures

Primary Outcome Measures

1. Surgical site infection rate. [From admission up to 2 weeks postpartum.]

   Surgical site infection rate.

Secondary Outcome Measures

1. Fever postpartum. [From admission up to 2 weeks postpartum.]

   The rate of fever over 38 degrees Celsius postpartum.

2. Need for antibiotics. [From admission up to 2 weeks postpartum.]

   The rate of antibiotic use.

3. Hospitalization length. [From admission up to 2 weeks postpartum.]

   The length of hospitalization postpartum.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant women undergoing elective cesarean section.

• Pregnant women undergoing emergent cesarean section.

Exclusion Criteria:

• Fever prior to surgery.

• Antibiotic use prior to surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam healthcare campus	Haifa		Israel

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

• Principal Investigator: Roy Lauterbach, MD, Rambam Healthcare Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ROY LAUTERBACH MD, Principal investigator, Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT04220294
• Other Study ID Numbers: 0621-19-RMB
• First Posted: Jan 7, 2020
• Last Update Posted: Nov 18, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections

Study Results

No Results Posted as of Nov 18, 2021