Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Povidone iodine 1% solution
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection
Eligibility Criteria
Inclusion Criteria:
- Age: from 20 to 35 old years.
- Elective cesarean section.
- Caesarean section time from skin incision to skin closure less than 60 minutes.
- Preoperative Hemoglobin more than 10 gm /dl.
- Body Mass Index: 20_30 Kg/m2 .
Exclusion Criteria:
- Body Mass Index: <20 or >30 Kg/m2.
- Diabetic patient.
- Feverish patient.
- Patient using steroids for chronic illness.
- Hypertension chronic or with pregnancy.
- Prelabour rupture of membranes.
- Difference in pre and postoperative hemoglobin more than 10%.
- Patients have a Coagulopathy disorder.
- Multiple pregnancy.
Sites / Locations
- Faculty of Medicine - Ain SHams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Povidone irrigation Group
Control Group
Arm Description
Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution.
Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution.
Outcomes
Primary Outcome Measures
Surgical site infection up to 14 days following elective caesarian section.
Infection involves only skin and subcutaneous tissue of this incision.
Occurs within 14 days after the operative procedure.
Includes at least one of the following:
purulent drainage is present (culture documentation not required)
organisms are isolated from fluid/tissue of the superficial incision
at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present.
the wound is deliberately opened by the surgeon
the surgeon or clinician declares the wound infected.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03549702
Brief Title
Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section
Official Title
Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section (Randomized Control Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
March 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to assess the efficacy of Povidone Iodine (Betadine®) irrigation of subcutaneous tissue prior to skin closure in reducing the incidence of surgical site infection after elective caesarean section and post discharge.
Detailed Description
All women will be counseled regarding mode of intervention and informed consent will be obtained. All women will be subjected to complete history taking, routine antenatal examination and investigations especially Hemoglobin test and 2 hour glucose tolerance test, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination.
Primary Outcome :
Surgical site infection up to 14 days following elective caesarian section.
Criteria of Surgical site infection:
Infection involves only skin and subcutaneous tissue of this incision. Occurs within 14 days after the operative procedure.
Includes at least one of the following:
purulent drainage is present (culture documentation not required)
organisms are isolated from fluid/tissue of the superficial incision
at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present.
the wound is deliberately opened by the surgeon
the surgeon or clinician declares the wound infected.
Secondary Outcome :
The need for secondary sutures closure of the infected wound after cleaning and debridement.
The need for other doses of antibiotic rather than the preoperative prophylactic one.
Postoperative fever exceeding 38.2, 24 hours following the caesarian section after exclusion of the other possible causes (eg: DVT, chest infections, Urinary tract infections).
The duration of post operative hospital stay
Coast effectiveness of hospital stay duration.
Randomization :
The study population will be randomly distributed according to the mode of intervention into 2 groups.
Randomization is performed using a Computer generated randomization system. Table of randomization is obtained.
Group 1 Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution.
Nature of Povidone Iodine: It's a stable chemical complex of polyvinylpyrrolidone and elemental iodine.with chemical formula (C6H9I2NO).
Antiseptic properties: it's a broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds, using the antiseptic properties of iodine.
Iodine has been recognized as an effective broad-spectrum bactericide, and is also effective against yeasts, molds, fungi, viruses, and protozoans.
In addition, it has been demonstrated that bacteria do not develop resistance to Povidone Iodine (Fleischer and Reimer, 1997).
Prophylactic 1gm of 3rd generation cephalosporins 30 minutes prior to skin incision.
The level of surgeon will be 2nd year residency or higher. Skin incision will be done by scalpel in Pfannenstiel manner. Subcutaneous tissue incision and division will be done using scalpel. Rectus sheath division will be done by scalpel with good hemostasis. Opening of the parietal peritoneum either sharp or blunt. Opening of the uterus in a C-shaped manner. Oxytocin 5 IU by slow intravenous injection will be used to encourage contraction of the uterus and to decrease blood loss.
The placenta will be removed using controlled cord traction and not manual removal.
Closure of the uterus in two continuous layers using polyglactin 910 No 1. Closure of parietal peritoneal. Closure of the rectus sheath in a continuous fashion using polyglactin 910 No1. Good hemostasis of subcutaneous tissue using the diathermy in coagulation mood. Irrigation of the subcutaneous tissue layers using povidone iodine using Betadine filled 20 cm syringe.
No insertion of subcutaneous tissue drain. No interrupted sutures in the skin. Approximating of the subcutaneous tissue using polyglactin 910 (2-0) if the tissue thickness more than 2 cm .
Closure of the skin using polypropylene (2-0) in subcuticular manner.
Group 2:
Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution.
Same steps as group 1 without subcutaneous tissue irrigation with Povidone iodine.
Allocation and Concealment 200 eligible women (who fulfill the inclusion and exclusion criteria) are to be randomly allocated into one of the two groups. Concealed allocation is adopted, however, in order to minimize selection bias. The allocated group numbers are concealed in serially-numbered opaque envelopes. Each envelope will contain the number of one of the two arms of the study, envelopes will be put in a box, and each woman under the study will pick one envelope which corresponds to the group to which she will be allocated. The envelopes are unsealed after recruitment of the cases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Povidone irrigation Group
Arm Type
Active Comparator
Arm Description
Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution.
Intervention Type
Drug
Intervention Name(s)
Povidone iodine 1% solution
Intervention Description
irrigation of subcutaneous tissue with Povidone-Iodine prior to skin closure
Primary Outcome Measure Information:
Title
Surgical site infection up to 14 days following elective caesarian section.
Description
Infection involves only skin and subcutaneous tissue of this incision.
Occurs within 14 days after the operative procedure.
Includes at least one of the following:
purulent drainage is present (culture documentation not required)
organisms are isolated from fluid/tissue of the superficial incision
at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present.
the wound is deliberately opened by the surgeon
the surgeon or clinician declares the wound infected.
Time Frame
14 Days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: from 20 to 35 old years.
Elective cesarean section.
Caesarean section time from skin incision to skin closure less than 60 minutes.
Preoperative Hemoglobin more than 10 gm /dl.
Body Mass Index: 20_30 Kg/m2 .
Exclusion Criteria:
Body Mass Index: <20 or >30 Kg/m2.
Diabetic patient.
Feverish patient.
Patient using steroids for chronic illness.
Hypertension chronic or with pregnancy.
Prelabour rupture of membranes.
Difference in pre and postoperative hemoglobin more than 10%.
Patients have a Coagulopathy disorder.
Multiple pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Azmy, MBBCH
Organizational Affiliation
Specialist of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine - Ain SHams University
City
Cairo
ZIP/Postal Code
202
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section
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