Iodine Drapes Used in TSA

Phase 4Enrolling By InvitationNCT07721415

tnicholson128 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

128

Conditions

Total Shoulder Arthroplasty Iodine Shoulder Surgery

Interventions

Total shoulder arthroplastyPROCEDURE

Participant will have total shoulder arthroplasty surgery

Iodine impregnated drapesDRUG

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 SamplesPROCEDURE

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

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Culture positivity rate

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

Time frame: 13 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.