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Normal Saline Irrigation Arm (Group 1) for Acne

N/A

Recruiting

Led By Hafiz F Kassam, MD

Research Sponsored by Orthopaedic Education and Research Institute (dba Hoag Orthopedics)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients requiring Total Shoulder Arthroplasty

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-operation, 3, 6, 12, & 24 months post-operation,

Awards & highlights

Study Summary

This trial aims to see if there is a difference in the presence of a type of bacteria called C acnes in samples taken from different depths of tissue before surgery. The participants will receive either Normal Sal

Who is the study for?

This trial is for individuals with wounds that need cleaning before surgery. Participants must be suitable for the study based on specific health criteria not detailed here.Check my eligibility

What is being tested?

The study aims to compare how effective two different wound cleaning solutions are at reducing bacteria in deep tissue: Normal Saline and Irrisept. It also looks at patient outcomes and joint movement after treatment.See study design

What are the potential side effects?

Potential side effects may include irritation or allergic reactions at the wound site, but specifics will depend on individual sensitivities to the irrigation solutions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need a shoulder replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operation, 3, 6, 12, & 24 months post-operation,

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operation, 3, 6, 12, & 24 months post-operation,

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operation, 3, 6, 12, & 24 months post-operation, for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

C Acnes Presence

Secondary outcome measures

American Shoulder and Elbow Surgeons Patient Reported Outcome Measure

Shoulder Range of Motion (ROM)

Trial Design

2Treatment groups

Active Control

Group I: Normal Saline Irrigation Arm (Group 1)Active Control1 Intervention

After deep dissection, and prior to implantation of components, 100 cc of normal saline will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.

Group II: Irrisept irrigation Arm (Group 2)Active Control1 Intervention

After deep dissection, and prior to implantation of components, 100 cc of Irrisept solution will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Orthopaedic Education and Research Institute (dba Hoag Orthopedics)Lead Sponsor

Irrimax CorporationIndustry Sponsor

9 Previous Clinical Trials

1,951 Total Patients Enrolled

Hafiz F Kassam, MDPrincipal InvestigatorHoag Orthopedics Education and Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase for this investigation currently ongoing?

"Indeed, details on clinicaltrials.gov show that this investigation is actively seeking volunteers. Posted initially on the 20th of March 2024 and last modified on the 18th of April 2024, this trial aims to enroll 126 participants at a single site."

Answered by AI

How large is the overall participant population involved in this research endeavor?

"Yes, the details on clinicaltrials.gov indicate that this trial is presently seeking participants. The study was initially shared on March 20th, 2024 and had its latest update on April 18th, 2024. A total of 126 patients are sought from a single site."

Answered by AI

Recent research and studies

Journal of Shoulder and Elbow SurgeryJournal

Propionibacterium Acnes Infection in Shoulder Arthroscopy Patients with Postoperative Pain

Horneff, John G., III, Jason E. Hsu, Pramod B. Voleti, Judith O'Donnell, and G. Russell Huffman. 2015. “Propionibacterium Acnes Infection in Shoulder Arthroscopy Patients with Postoperative Pain”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2015.03.008.

Journal of Shoulder and Elbow SurgeryJournal

Benzoyl Peroxide and Clindamycin Topical Skin Preparation Decreases Propionibacterium Acnes Colonization in Shoulder Arthroscopy

Dizay, Hailey H., Diana G. Lau, and Wesley M. Nottage. 2017. “Benzoyl Peroxide and Clindamycin Topical Skin Preparation Decreases Propionibacterium Acnes Colonization in Shoulder Arthroscopy”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2017.03.003.

Journal of Shoulder and Elbow SurgeryJournal

Frequent Isolation of Propionibacterium Acnes from the Shoulder Dermis Despite Skin Preparation and Prophylactic Antibiotics

Phadnis, Joideep, David Gordon, Jeganath Krishnan, and Gregory Ian Bain. 2016. “Frequent Isolation of Propionibacterium Acnes from the Shoulder Dermis Despite Skin Preparation and Prophylactic Antibiotics”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2015.08.002.

clinicaltrials.govStudy