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Enrolling by Invitation

NCT Number: NCT07721415

Iodine Drapes Used in TSA

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

Enrolling by Invitation

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Key information

Conditions

Total Shoulder Arthroplasty Iodine Shoulder Surgery

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total shoulder arthroplasty

Procedure

Participant will have total shoulder arthroplasty surgery

Iodine impregnated drapes

Drug

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.

Tissue Culture Samples

Procedure

One deep tissue swab will be taken after final shoulder implant placement and sent for culture to see if bacteria grows after surgery.

Primary outcomes

  1. Culture positivity rate

    Time frame: 13 days

    One deep tissue swab will be taken after final implant placement and sent for culture to see if bacteria grows after surgery.

Sponsors and collaborators

Lead sponsor

tnicholson

Other

Registry information

Official study title

Effect of Iodine Impregnated Drapes on the Rate of Positive Cultures in Primary Total Shoulder Arthroplasty - a Prospective, Randomized Study

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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