Surgiphor Us in TSA

Phase 4

• Conditions: Total Shoulder Arthroplasty; Shoulder Infection; Povidone Iodine
• Interventions: Drug: Surgiphor; Drug: sterile saline solution; Procedure: Sample Collection

• Registration Number: NCT06601803
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis. Surgiphor (sterile Povidone-Iodine) wound irrigation, is a solution used in orthopaedic surgery and other surgical fields to kill bacteria intraoperatively. The Iodine dissociates from complex and has antimicrobial properties, causing cell death of bacteria, fungi, and viruses through interactions with proteins, nucleotides, and fatty acids in the cytoplasm and cytoplasmic membrane.

This study examines the use of Povidone-Iodine during primary shoulder arthroplasty.

Detailed Description

The purpose of this study is to determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-16
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Adults age >18 years
• Participants undergoing elective primary total shoulder arthroplasty
• Participants willing to provide written consent

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Exclusion Criteria

• History of prior surgery to the operative shoulder
• Known allergy to povidone iodine, iodine or shellfish
• active clinical infection
• participation in other clinical trials

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)	Surgiphor	This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components
Total Shoulder Arthroplasty washed with Saline	sterile saline solution	This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components
Total Shoulder Arthroplasty washed with Saline	Sample Collection	This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components
Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)	Sample Collection	This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components

Primary Outcome Measures

Name	Time	Method
Reduction or elimination of bacteria	90 days	To determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty participants will be followed to watch for clinical signs of infection.

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States