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Enrolling by invitation NCT07721415

Iodine Drapes Used in TSA

Phase IV Interventional Total Shoulder Arthroplasty Iodine Shoulder Surgery

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: Total shoulder arthroplasty, Iodine impregnated drapes, Tissue Culture Samples.
Who it may be relevant to
Registry conditions: Total Shoulder Arthroplasty, Iodine, Shoulder Surgery. Basic parameters: from 18 years · Male.
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 Iodine Impregnated Drapes on the Rate of Positive Cultures in Primary Total Shoulder Arthroplasty - a Prospective, Randomized Study

Overview

This study will directly compare the positive culture rate in shoulder arthroplasty using iodine-impregnated versus non-iodine-impregnated drapes used during surgery

Interventions

  • Procedure Total shoulder arthroplasty
    Participant will have total shoulder arthroplasty surgery
  • Drug Iodine impregnated drapes
    After cleaning the shoulder area in preparation for surgery, the area will be covered and draped using iodine impregnated drapes prior to the start of the participants surgery.
  • Procedure Tissue Culture Samples
    One deep tissue swab will be taken after final shoulder implant placement and sent for culture to see if bacteria grows after surgery.

Primary outcome measures

  • Culture positivity rate [Time frame: 13 days]

Eligibility criteria

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

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: NCT07721415 · SNAM20251199

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗