NCT04006067

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

June 29, 2019

Last Update Submit

March 9, 2020

Conditions

Decreasing Wound Infection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group A

EXPERIMENTAL
Other: changing surgical gloves

Group B

NO INTERVENTION

Interventions

changing surgical glovesOTHER

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 A

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both elective and emergency cesarean sections.
  • Patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case.

You may not qualify if:

  • Women with active infection during the procedure.
  • Women did not receive the standard preoperative antibiotic prophylaxis.
  • Women with diagnosis of chorioamnionitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AFHSR

Khamis Mushait, Saudi Arabia

RECRUITING

Central Study Contacts

Khalid ibrahim, MD

CONTACT

00966596984055dr.khalidkhader77@yahoo.com

ahmed morsi, MD

CONTACT

00966596984055

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 29, 2019

First Posted

July 2, 2019

Study Start

June 20, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

SA(1)