Surgiphor Us in TSA

NCT06601803 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: SNAM20D1057
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Shoulder Arthroplasty; Shoulder Infection; Povidone Iodine

Outcome Measures

Primary Outcomes (1)

• Reduction or elimination of bacteria

  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.

  90 days

Study Arms (2)

Total Shoulder Arthroplasty washed with Saline

ACTIVE COMPARATOR

This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components

Drug: sterile saline solution; Procedure: Sample Collection

Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)

ACTIVE COMPARATOR

This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components

Drug: Surgiphor; Procedure: Sample Collection

Interventions

sterile saline solution DRUG

The shoulder will be washed with normal sterile saline before and after placing the shoulder implant

Total Shoulder Arthroplasty washed with Saline

Surgiphor DRUG

The shoulder will be washed with Surgiphor (Povidone Iodine) before and after placing the shoulder implant

Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)

Sample Collection PROCEDURE

During the surgical procedure, 4 swabs of the surgical wound will be taken at various times throughout the procedure

Total Shoulder Arthroplasty washed with Saline; Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)