Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04006067
Enrollment
600
Registered
2019-07-02
Start date
2019-06-20
Completion date
2020-10-31
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decreasing Wound Infection

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

Interventions

OTHERchanging 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.

Sponsors

Armed Forces Hospitals, Southern Region, Saudi Arabia
CollaboratorOTHER_GOV
khalid abd aziz mohamed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of any post cesarean wound related complication8 weeksincluding wound hematoma, seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment

Countries

Saudi Arabia

Contacts

Primary ContactKhalid ibrahim, MD
dr.khalidkhader77@yahoo.com00966596984055
Backup Contactahmed morsi, MD
00966596984055

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026