Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05276687
Collaborator
(none)
80
3
19

Study Details

Study Description

Brief Summary

  1. Infection control and health-care-associated infections and Safety of medical service providers

  2. Evidence based management of common medical and surgical problems

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Surgical wound infection is the presence of replicating micro-organisms within a wound of a surgery leading to host injury. Superficial sternal wound infection (SSWI) is the infection that affects the skin and subcutaneous tissues and the pectoralis fascia(1,2). Deep sternal wound infection (DSWI) is the infection affecting muscle layer and the bony sternum, it is one of the most complex and potentially devastating complications following median sternotomy in cardiac surgery with a significant impact on both patient prognosis and hospital budgets, despite of many advances in prevention, it is still remaining significant, and ranges between 0.5% and 6.8%(2), with in-hospital mortality between 7% and 35%. moreover, mid- and long- term survival is significantly reduced in patients that have experienced DSWI(3). Sternal dehiscence is the process of separation of bony sternum which is often accompanied by mediastinits(4). Although prevention of infection following arthroplasty requires a multifaceted approach, the use of intraoperative irrigation is an important component of any protocol. Recent clinical practice guidelines from the Centers for Disease Control, World Health Organization, and International Consensus Meeting on Musculoskeletal Infection advocate the use of a dilute povidone-iodine solution prior to wound closure. This experience suggests that this practice is safe, inexpensive, and easily implemented(5). The present study is going to discuss the effect of dilute povidone-iodine irrigation vs vancomycine irrigation intraoperative in prevention of postoperative infection after cardiac surgery.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diluted betadine

Drug: Betadine
Wound irrigation

Experimental: Powdered vancomycin

Drug: Vancomycin
instillation in the wound

No Intervention: No intervention

Outcome Measures

Primary Outcome Measures

  1. Superficial wound infection [Within 20 days]

  2. Deep wound infection [Within 20 days]

Secondary Outcome Measures

  1. Healing of sternum ( within 2 months) [20 days to 60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age from 1 to 65 years, primary or redo cases
Exclusion Criteria:
  • diabetic patients

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdelrahman Hamed Ahmed, Resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05276687
Other Study ID Numbers:
  • diluted betadine vs antibiotic
First Posted:
Mar 11, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022