Surgiphor Us in TSA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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

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Total Shoulder Arthroplasty Shoulder Infection Povidone Iodine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Total Shoulder Arthroplasty washed with Saline

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

Group Type ACTIVE_COMPARATOR

sterile saline solution

Intervention Type DRUG

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

Sample Collection

Intervention Type 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 Surgiphor (Povidone Iodine)

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

Group Type ACTIVE_COMPARATOR

Surgiphor

Intervention Type DRUG

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

Sample Collection

Intervention Type PROCEDURE

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

Interventions

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sterile saline solution

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

Intervention Type DRUG

Surgiphor

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

Intervention Type DRUG

Sample Collection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes