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Iodine-coated surgical drapes may cut infection risk in shoulder replacements

NCT ID NCT07721415

Disease control Sponsor: tnicholson Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether using iodine-impregnated drapes during shoulder replacement surgery lowers the chance of bacterial contamination. Adult men scheduled for a first-time total shoulder replacement will be randomly assigned to receive either standard drapes or iodine-impregnated drapes. A tissue sample taken after the implant is placed will be checked for bacterial growth. The goal is to see if the special drapes reduce the number of positive cultures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iodine-impregnated drapes
What this could lead to
If effective, using iodine-impregnated drapes during shoulder replacement could lower the risk of surgical-site infections.
What could go wrong
This is a small, early-phase trial focused on bacterial cultures, not actual infection rates. Results may not translate to fewer infections in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults ≥ 18 years * Written informed consent * Elective primary total shoulder arthroplasty * Male patients Exclusion Criteria: * Prior surgery on the operative shoulder * Iodine allergy * Participation in other clinical trials * Active infection

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IODINE Shoulder surgery Total shoulder arthroplasty

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rothman Orthopaedic Institute

    Philadelphia, Pennsylvania, 19107, United States

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