NCT07721415

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
42mo left

Started Jan 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Dec 2029

First Submitted

Initial submission to the registry

December 29, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

4 years

First QC Date

December 29, 2025

Last Update Submit

July 20, 2026

Conditions

Total Shoulder ArthroplastyIodineShoulder Surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    13 days

Study Arms (2)

Iodine Drapes

ACTIVE COMPARATOR

When the participant is in the operating room Surgical draping will be performed using cloth drapes impregnated with iodine

Procedure: Total shoulder arthroplastyDrug: Iodine impregnated drapesProcedure: Tissue Culture Samples

Non-iodine drapes

ACTIVE COMPARATOR

When the participant is in the operating room Surgical draping will be performed using standard cloth drapes

Procedure: Total shoulder arthroplastyProcedure: Tissue Culture Samples

Interventions

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.

Iodine Drapes
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.

Iodine DrapesNon-iodine drapes
Total shoulder arthroplastyPROCEDURE

Participant will have total shoulder arthroplasty surgery

Iodine DrapesNon-iodine drapes

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years
  • Written informed consent
  • Elective primary total shoulder arthroplasty
  • Male patients

You may not qualify if:

  • Prior surgery on the operative shoulder
  • Iodine allergy
  • Participation in other clinical trials
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Shoulder

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Surena Namdari, MD

    Rothman Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Clinical Trials

Study Record Dates

First Submitted

December 29, 2025

First Posted

July 23, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)