A Phase 4 interventional study of sterile saline solution and Surgiphor in Total Shoulder Arthroplasty, Shoulder Infection and Povidone Iodine, sponsored by Rothman Institute Orthopaedics. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Rothman Institute Orthopaedics · Phase 4, Interventional, and Prevention
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.
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
Rothman Institute Orthopaedics is the lead sponsor of 119 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components
Drug: sterile saline solution · Procedure: Sample Collection
This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components
Drug: Surgiphor · Procedure: Sample Collection
The shoulder will be washed with normal sterile saline before and after placing the shoulder implant
The shoulder will be washed with Surgiphor (Povidone Iodine) before and after placing the shoulder implant
During the surgical procedure, 4 swabs of the surgical wound will be taken at various times throughout the procedure
Reduction or elimination of bacteria
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.
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Sep 2025, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rothman Institute Orthopaedics →