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

Primary Purpose

Decreasing Wound Infection

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
changing surgical gloves
Sponsored by
khalid abd aziz mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Decreasing Wound Infection

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • AFHSRRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 29, 2019
Last Updated
March 9, 2020
Sponsor
khalid abd aziz mohamed
Collaborators
Armed Forces Hospitals, Southern Region, Saudi Arabia
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1. Study Identification

Unique Protocol Identification Number
NCT04006067
Brief Title
The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication
Official Title
The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication. A Single Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
khalid abd aziz mohamed
Collaborators
Armed Forces Hospitals, Southern Region, Saudi Arabia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decreasing Wound Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
changing surgical gloves
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of any post cesarean wound related complication
Description
including wound hematoma, seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both elective and emergency cesarean sections. Patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. Exclusion Criteria: Women with active infection during the procedure. Women did not receive the standard preoperative antibiotic prophylaxis. Women with diagnosis of chorioamnionitis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khalid ibrahim, MD
Phone
00966596984055
Email
dr.khalidkhader77@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed morsi, MD
Phone
00966596984055
Facility Information:
Facility Name
AFHSR
City
Khamis Mushait
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalid ibrahim, MD
Phone
00966596984055
First Name & Middle Initial & Last Name & Degree
mohamed hussein, MD
Phone
00966596984055

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
will be shared later on

Learn more about this trial

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

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