Total Shoulder ArthroplastyPhase 4NCT06601803
Surgiphor Us in TSA
A Phase 4 study testing sterile saline solution, Surgiphor and Sample Collection in people with Total Shoulder Arthroplasty and Shoulder Infection, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Shoulder Arthroplasty, Shoulder Infection, Povidone Iodine
- What is being tested?
- sterile saline solution, Surgiphor and Sample Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 30 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age \>18 years
- Participants undergoing elective primary total shoulder arthroplasty
- Participants willing to provide written consent
Who cannot join
- History of prior surgery to the operative shoulder
- Known allergy to povidone iodine, iodine or shellfish
- active clinical infection
- participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
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
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.
Read the 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
- Being tested
- sterile saline solution, Surgiphor, Sample Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterile saline solutionDrug
The shoulder will be washed with normal sterile saline before and after placing the shoulder implant
SurgiphorDrug
The shoulder will be washed with Surgiphor (Povidone Iodine) before and after placing the shoulder implant
Sample CollectionProcedure or surgery
During the surgical procedure, 4 swabs of the surgical wound will be taken at various times throughout the procedure
| Study group | Role | What they receive |
|---|---|---|
| Total Shoulder Arthroplasty washed with Saline | Active comparator | This arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components Receives: Drug: sterile saline solution; Procedure: Sample Collection |
| Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine) | Active comparator | This arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components Receives: Drug: Surgiphor; Procedure: Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Sep 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601803
- Sponsor's protocol ID
- SNAM20D1057
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06601803
- Acronym / sponsor ID
- SNAM20D1057
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Shoulder Arthroplasty washed with Saline | Active comparator | Drug: sterile saline solution, Procedure: Sample CollectionThis arm will consist of sterile normal saline to be used before and after placement of shoulder arthroplasty components |
| Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine) | Active comparator | Drug: Surgiphor, Procedure: Sample CollectionThis arm will consist of Surgiphor to be used before and after placement of shoulder arthroplasty components |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age \>18 years
- Participants undergoing elective primary total shoulder arthroplasty
- Participants willing to provide written consent
Key exclusion criteria (4 listed)
- History of prior surgery to the operative shoulder
- Known allergy to povidone iodine, iodine or shellfish
- active clinical infection
- participation in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sterile saline solutionThe shoulder will be washed with normal sterile saline before and after placing the shoulder implant | Drug | Total Shoulder Arthroplasty washed with Saline |
| SurgiphorThe shoulder will be washed with Surgiphor (Povidone Iodine) before and after placing the shoulder implant | Drug | Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine) |
| Sample CollectionDuring the surgical procedure, 4 swabs of the surgical wound will be taken at various times throughout the procedure | Procedure or surgery | Total Shoulder Arthroplasty washed with Saline, Total Shoulder Arthroplasty washed with Surgiphor (Povidone Iodine) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sterile saline solution, Surgiphor and Sample Collection in people with Total Shoulder Arthroplasty and Shoulder Infection, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction or elimination of bacteria (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.