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Surgiphor Us in TSA

NCT06601803 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

DRUG

sterile saline solution

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

DRUG

Surgiphor

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

PROCEDURE

Sample Collection

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06601803 on ClinicalTrials.gov