Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine
Primary Purpose
Wound Infection
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Povidone iodine
Sponsored by
About this trial
This is an interventional prevention trial for Wound Infection focused on measuring Cesarean section, Betadine, Wound infection
Eligibility Criteria
Inclusion Criteria:
- All women having either first time or repeat cesarean section whether elective or emergency.
Exclusion Criteria:
- Women with prolonged rupture of membranes more than 12 hours.
- Women with morbid obesity with BMI>35.
- Women with diabetes, hypertension or anemia with hemoglobin<9.
- Women on corticosteroid therapy or immunosuppressed women.
- Women with intraoperative hemorrhage or hematoma formation.
- Women allergic to betadine.
- The cesarean section which duration exceed one hour or associated with other surgical procedure.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Betadine group
No intervention group
Arm Description
Subcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues
No swabbing of subcutaneous tissue of cesarean section wounds
Outcomes
Primary Outcome Measures
Detect and record the incidence of surgical wound infection in both groups
: Women in both groups will be followed up during hospital stay and outpatient clinic visit for one month after cesarean delivery for surgical site complications which will be evaluated by the researcher
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02868372
Brief Title
Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine
Official Title
The Efficacy of Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine to Prevent Postoperative Wound Infection: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study has 2 groups. Group A in which the subcutaneous tissue will be swabbed with 10 cc of undiluted 10% povidone iodine and will not be mobbed. Group B ; No swabbing. Women in both groups will be followed up during hospital stay and outpatient clinic visits a week and a month after cesarean delivery for surgical site complications which will be evaluated by the researcher.
Detailed Description
Aim of the study:
To assess the efficacy of subcutaneous swabbing of cesarean section wounds with povidone iodine to prevent postoperative wound infection.
Study Design: Randomized controlled trial.
Subjects: Women having a cesarean delivery.
The women will have a full description of the study and Subjects will be randomized by selecting a sequentially numbered sealed envelope to one of each group which will be opened during closure of rectus sheath.
Method :
Patient will receive single dose of prophylactic antibiotic (2-grams first generation cephalosporin) intravenous at time of cesarean delivery during induction of anesthesia. -The same type of suturing material; vicryl No1 will be used for rectus Sheath repair in both groups.
The same type of suturing material will be used to suture the subcutaneous tissue and the skin (vicryl NO 2/0).
Follow up : Women in both groups will be followed up during hospital stay and outpatient clinic visits a week and a month after cesarean delivery for surgical site complications which will be evaluated by the researcher.
Outcome :The study outcome is to detect and record the incidence of surgical wound infection in both groups.It is a composite outcome with presence of any of the following is considered infection:
Induration
Swelling of the wound edges
Discharge of pus or wound dehiscence.
Purulent drainage with or without laboratory confirmation, from the superficial incision
Pain or tenderness with redness, or heat
Superficial incision being deliberately opened by surgeon.
Sample size estimation:
It was calculated that 269 patients are required in each arm to detect a 5% reduction (from 7% to 2%) in cesarean section wound infection rates between study and control groups.
Statistical Analysis:
Data will be tabulated using Statistical Package for Social Scientists (SPSS) program and statistical analysis will be carried out with suitable statistical tests. Continuous variables will be presented as mean and standard deviation, and will be compared using Student-t-test. Dichotomous variables will be compared using Chi square and the cut off point for P-value will be less than 0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
Cesarean section, Betadine, Wound infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
538 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Betadine group
Arm Type
Active Comparator
Arm Description
Subcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues
Arm Title
No intervention group
Arm Type
No Intervention
Arm Description
No swabbing of subcutaneous tissue of cesarean section wounds
Intervention Type
Drug
Intervention Name(s)
Povidone iodine
Other Intervention Name(s)
Betadine
Intervention Description
After closure of the anterior wall of the rectus sheath, the subcutaneous tissues of the cesarean section wound will be swabbed with 10% undiluted Povidone iodine without mobbing.
Primary Outcome Measure Information:
Title
Detect and record the incidence of surgical wound infection in both groups
Description
: Women in both groups will be followed up during hospital stay and outpatient clinic visit for one month after cesarean delivery for surgical site complications which will be evaluated by the researcher
Time Frame
One month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All women having either first time or repeat cesarean section whether elective or emergency.
Exclusion Criteria:
Women with prolonged rupture of membranes more than 12 hours.
Women with morbid obesity with BMI>35.
Women with diabetes, hypertension or anemia with hemoglobin<9.
Women on corticosteroid therapy or immunosuppressed women.
Women with intraoperative hemorrhage or hematoma formation.
Women allergic to betadine.
The cesarean section which duration exceed one hour or associated with other surgical procedure.
12. IPD Sharing Statement
Plan to Share IPD
No
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Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine
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