NCT06601803

Surgiphor Us in TSA

Effect of Surgiphor (sterile Povidone-Iodine) Wound Irrigation on Rate of Positive Deep Culture and NGS in Primary Total Shoulder Arthroplasty- a Prospective, Randomized Pilot Study

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Total Shoulder Arthroplasty
• Shoulder Infection
• Povidone Iodine

Interventions

Type	Name	Description
DRUG	sterile saline solution	The shoulder will be washed with normal sterile saline before and after placing the shoulder implant
DRUG	Surgiphor	The shoulder will be washed with Surgiphor (Povidone Iodine) before and after placing the shoulder implant
PROCEDURE	Sample Collection	During the surgical procedure, 4 swabs of the surgical wound will be taken at various times throughout the procedure

Timeline

• Start date: 2024-09-16
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study