The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication

NCT ID: NCT04006067

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2020-10-31

Brief Summary

The investigators aim to compare the effect of changing their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure versus no intervention in the incidence of postoperative wound infections in pregnant women undergoing Caesarean section. The primary outcome is the incidence of any post cesarean wound related complication, including wound seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery, while the secondary outcomes are Postoperative fever: defined as greater than 38 degrees Celsius or post cesarean endometritis: defined as a clinical diagnosis, usually involving fever, uterine fundal tenderness, or purulent lochia requiring antibiotic therapy or Combined wound complications and endometritis.

Detailed Description

The investigators conduct a prospective randomized study at Department of Obstetrics and Gynecology, AFHSR since April 2019 till October 2019, after approval of the study protocol by the Local Ethical Committee.

Patients undergoing Both elective and emergency cesarean sections and Patients received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. All patients received appropriate pre-operative antibiotics, chlorohexidine skin prep except where allergies prohibited, and hair clipping as indicated.

The patients (600) are divided into two groups, Group A (300) during CS the surgical team change their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure, while in Group B (300) no intervention

Conditions

Decreasing Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group A

Group Type: EXPERIMENTAL

changing surgical gloves

Intervention Type: OTHER

All the surgical team including surgeons, surgical assists and scrub technicians replaced their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure.

Group B

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

changing surgical gloves

All the surgical team including surgeons, surgical assists and scrub technicians replaced their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Both elective and emergency cesarean sections.

2. Patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case.

Exclusion Criteria

1. Women with active infection during the procedure.

2. Women did not receive the standard preoperative antibiotic prophylaxis.

3. Women with diagnosis of chorioamnionitis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Armed Forces Hospitals, Southern Region, Saudi Arabia

OTHER_GOV

Sponsor Role: collaborator

khalid abd aziz mohamed

OTHER

Sponsor Role: lead

Responsible Party

khalid abd aziz mohamed

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

AFHSR

Khamis Mushait, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Khalid ibrahim, MD

Role: CONTACT

dr.khalidkhader77@yahoo.com

00966596984055

ahmed morsi, MD

Role: CONTACT

00966596984055

Facility Contacts

Khalid ibrahim, MD

Role: primary

00966596984055

mohamed hussein, MD

Role: backup

00966596984055

Other Identifiers

khalid-shafik

Identifier Type: -

Identifier Source: org_study_id