Iodine Drapes Used in TSA

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
tnicholson
Study ID
NCT07721415
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Iodine
  • Shoulder Surgery
  • Total Shoulder Arthroplasty

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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

Key Dates

First listed
Jul 23, 2026
Start date
Jan 5, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Iodine Drapes
    When the participant is in the operating room Surgical draping will be performed using cloth drapes impregnated with iodine
  • Active Comparator: Non-iodine drapes
    When the participant is in the operating room Surgical draping will be performed using standard cloth drapes

Primary Outcome Measure

Culture positivity rate [ Time Frame: 13 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

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Rothman Orthopaedic Institute· Philadelphia, PA

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