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Wound Irrigation 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

Must not have

Age younger than 18 years

History of shoulder infection

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I need a shoulder replacement surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have had a shoulder infection in the past.

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I have not had cortisone shots in the last 3 months.

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I have taken antibiotics within 2 weeks before surgery.

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I have been diagnosed with rheumatoid arthritis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

C Acnes Presence

Secondary study objectives

American Shoulder and Elbow Surgeons Patient Reported Outcome Measure

Shoulder Range of Motion (ROM)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: 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.

Group II: 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.

0 / 6Eligibility criteria met