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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infection focused on measuring Cesarean section, Betadine, Wound infection

Eligibility Criteria

20 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    July 29, 2016
    Last Updated
    August 14, 2016
    Sponsor
    Assiut University
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    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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