Surgiphor Us in TSA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sterile saline solution, Surgiphor, Sample Collection.
- Who it may be relevant to
- Registry conditions: Total Shoulder Arthroplasty, Shoulder Infection, Povidone Iodine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Detailed description
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
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
Primary outcome measures
- Reduction or elimination of bacteria [Time frame: 90 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Rothman Orthopaedic Institute — Philadelphia
Identifiers
NCT: NCT06601803 · SNAM20D1057