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Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine

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ClinicalTrials.gov Identifier: NCT02868372
Recruitment Status : Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Essam Rashad Abdel-Hafeez Othman, Assiut University

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.

Condition or disease Intervention/treatment Phase
Wound Infection Drug: Povidone iodine Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : September 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Betadine group
Subcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues
Drug: Povidone iodine
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.
Other Name: Betadine

No Intervention: No intervention group
No swabbing of subcutaneous tissue of cesarean section wounds



Primary Outcome Measures :
  1. Detect and record the incidence of surgical wound infection in both groups [ Time Frame: One month ]
    : 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Responsible Party: Essam Rashad Abdel-Hafeez Othman, Associate professor, OB-GYN department- Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT02868372     History of Changes
Other Study ID Numbers: AUH2
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Essam Rashad Abdel-Hafeez Othman, Assiut University:
Cesarean section
Betadine
Wound infection

Additional relevant MeSH terms:
Wounds and Injuries
Wound Infection
Infection
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes