Surgiphor Us in TSA

Effect of Surgiphor (sterile Povidone-Iodine) Wound Irrigation on Rate of Positive Deep Culture and NGS in Primary Total Shoulder Arthroplasty- a Prospective, Randomized Pilot Study

Status

Enrolling by invitation

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06601803

Enrollment

126

Registered

2024-09-19

Start date

2024-09-16

Completion date

2025-09-30

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Shoulder Arthroplasty, Shoulder Infection, Povidone Iodine

Brief summary

Bacteria is occasionally present in the shoulder during shoulder arthroplasty surgery and is hypothesized to increase the risk of failure of the prosthesis. Surgiphor (sterile Povidone-Iodine) wound irrigation, is a solution used in orthopaedic surgery and other surgical fields to kill bacteria intraoperatively. The Iodine dissociates from complex and has antimicrobial properties, causing cell death of bacteria, fungi, and viruses through interactions with proteins, nucleotides, and fatty acids in the cytoplasm and cytoplasmic membrane. This study examines the use of Povidone-Iodine during primary shoulder arthroplasty.

Detailed description

The purpose of this study is to determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty

Interventions

DRUGSurgiphor

The shoulder will be washed with Surgiphor (Povidone Iodine) before and after placing the shoulder implant

PROCEDURESample Collection

During the surgical procedure, 4 swabs of the surgical wound will be taken at various times throughout the procedure

DRUGsterile saline solution

The shoulder will be washed with normal sterile saline before and after placing the shoulder implant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Adults age >18 years * Participants undergoing elective primary total shoulder arthroplasty * Participants willing to provide written consent

Exclusion criteria

* History of prior surgery to the operative shoulder * Known allergy to povidone iodine, iodine or shellfish * active clinical infection * participation in other clinical trials

Design outcomes

Primary

Measure	Time frame	Description
Reduction or elimination of bacteria	90 days	To determine the rate of reduction of positive cultures collected before and after wound irrigation with either Surgiphor or sterile normal saline during primary total shoulder arthroplasty participants will be followed to watch for clinical signs of infection.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026