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

Decreasing Wound Infection Clinical Trial

Official title:

The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication. A Single Blind Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04006067
• Other study ID #: khalid-shafik
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: October 2020

Study information

• Verified date: March 2020
• Source: Benha University
• Contact: Khalid ibrahim, MD
• Phone: 00966596984055
• Email: dr.khalidkhader77[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Decreasing Wound Infection
• Surgical Wound
• Wound Infection
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Saudi Arabia	AFHSR	Khamis Mushait

Sponsors (2)

Lead Sponsor	Collaborator
khalid abd aziz mohamed	Armed Forces Hospitals, Southern Region, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of any post cesarean wound related complication	including wound hematoma, seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment	8 weeks