Surgiphor Us in TSA

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT06601803
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Povidone Iodine
  • Shoulder Infection
  • Total Shoulder Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 16, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: 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
  • Active Comparator: 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

Primary Outcome Measure

Reduction or elimination of bacteria [ Time Frame: 90 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

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