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ENROLLING BY INVITATION
NCT06601803
PHASE4

Surgiphor Us in TSA

Sponsor: Rothman Institute Orthopaedics

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2024-09-16

Completion Date

2025-09-30

Last Updated

2024-09-19

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States