Surgiphor Us in TSA

Rothman Institute Orthopaedics

Status and phase: Invitation-only; Phase 4

Conditions: Total Shoulder Arthroplasty; Shoulder Infection; Povidone Iodine

Treatments: Drug: sterile saline solution; Drug: Surgiphor; Procedure: Sample Collection

Study type: Interventional

Funder types: Other

Identifiers

NCT06601803

SNAM20D1057

Details and patient eligibility

About

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.

Full 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

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Total Shoulder Arthroplasty washed with Saline

Active Comparator group

Description:

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

Treatment:

Procedure: Sample Collection

Drug: sterile saline solution

Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine)

Active Comparator group

Description:

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

Treatment:

Procedure: Sample Collection

Drug: Surgiphor