Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section

NCT03549702 | Completed

• 1 other identifier: PovidIodCS
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  14 Days

Study Arms (2)

Povidone irrigation Group

ACTIVE COMPARATOR

Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution.

Drug: Povidone iodine 1% solution

Control Group

NO INTERVENTION

Includes the 100 women who will undergo elective caesarian section without subcutaneous tissue irrigation with Povidone iodine 1% solution.

Interventions

Povidone iodine 1% solution DRUG

irrigation of subcutaneous tissue with Povidone-Iodine prior to skin closure

Povidone irrigation Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine - Ain SHams University

Cairo, 202, Egypt

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodine; Solutions

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pharmaceutical Preparations

Study Officials

• George Azmy, MBBCH

  Specialist of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: June 8, 2018
• Study Start: January 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: March 3, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-05

Locations

EG (1)