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Enrolling by Invitation

NCT Number: NCT06601803

Surgiphor Us in TSA

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.

Enrolling by Invitation

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Key information

Conditions

Total Shoulder Arthroplasty Povidone Iodine Shoulder Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sterile saline solution

Drug

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

Surgiphor

Drug

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

Sample Collection

Procedure

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

Primary outcomes

  1. Reduction or elimination of bacteria

    Time frame: 90 days

    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.

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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