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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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ClinicalTrials.gov Identifier: NCT03549702
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
George Adel Azmy, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Povidone iodine 1% solution Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section (Randomized Control Trial)
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : March 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Povidone irrigation Group
Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution.
Drug: Povidone iodine 1% solution
irrigation of subcutaneous tissue with Povidone-Iodine prior to skin closure

No Intervention: Control Group
Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution.



Primary Outcome Measures :
  1. Surgical site infection up to 14 days following elective caesarian section. [ Time Frame: 14 Days ]
    • 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:

      1. purulent drainage is present (culture documentation not required)
      2. organisms are isolated from fluid/tissue of the superficial incision
      3. at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present.
      4. the wound is deliberately opened by the surgeon
      5. the surgeon or clinician declares the wound infected.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: from 20 to 35 old years.
  2. Elective cesarean section.
  3. Caesarean section time from skin incision to skin closure less than 60 minutes.
  4. Preoperative Hemoglobin more than 10 gm /dl.
  5. Body Mass Index: 20_30 Kg/m2 .

Exclusion Criteria:

  1. Body Mass Index: <20 or >30 Kg/m2.
  2. Diabetic patient.
  3. Feverish patient.
  4. Patient using steroids for chronic illness.
  5. Hypertension chronic or with pregnancy.
  6. Prelabour rupture of membranes.
  7. Difference in pre and postoperative hemoglobin more than 10%.
  8. Patients have a Coagulopathy disorder.
  9. Multiple pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549702


Locations
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Egypt
Faculty of Medicine - Ain SHams University
Cairo, Egypt, 202
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: George Azmy, MBBCH Specialist of Obstetrics and Gynecology

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Responsible Party: George Adel Azmy, Specialist in Obstetrics and Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03549702     History of Changes
Other Study ID Numbers: PovidIodCS
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes