Iodine Drapes Used in TSA

NCT07721415 — Phase 4, Enrolling by invitation, 128 participants, tnicholson

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07721415
Status	Enrolling by invitation
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	128 (Estimated)
Sponsor	tnicholson (Other)
Conditions	Total Shoulder Arthroplasty, Iodine, Shoulder Surgery
Interventions	Total shoulder arthroplasty, Iodine impregnated drapes, Tissue Culture Samples (Procedure, drug)
Dates	start 2026-01-05, primary completion 2029-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2026-07-23, last updated 2026-07-23
Locations	1 site in United States

-Summary

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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Iodine Drapes	Active comparator	Procedure: Total shoulder arthroplasty; Drug: Iodine impregnated drapes; Procedure: Tissue Culture Samples	When the participant is in the operating room Surgical draping will be performed using cloth drapes impregnated with iodine
Non-iodine drapes	Active comparator	Procedure: Total shoulder arthroplasty; Procedure: Tissue Culture Samples	When the participant is in the operating room Surgical draping will be performed using standard cloth drapes

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.

+Outcome measures

Primary outcomes

Culture positivity rate [13 days]: One deep tissue swab will be taken after final implant placement and sent for culture to see if bacteria grows after surgery.

+Eligibility

Sex: Male, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Rothman Orthopaedic Institute	Philadelphia, Pennsylvania	United States

+Investigators

Surena Namdari, MD, Principal investigator, Rothman Orthopaedic Institute