Iodine Drapes Used in TSA

July 20, 2026 updated by: tnicholson

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iodine Drapes
When the participant is in the operating room Surgical draping will be performed using cloth drapes impregnated with iodine
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.
Active Comparator: Non-iodine drapes
When the participant is in the operating room Surgical draping will be performed using standard cloth drapes
Procedure: Total shoulder arthroplasty
Participant will have total shoulder arthroplasty 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

tnicholson

Investigators

  • Principal Investigator: Surena Namdari, MD, Rothman Orthopaedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNAM20251199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Shoulder Surgery

Clinical Trials on Total shoulder arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe