Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis

Study Overview
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Brief Summary
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This is a prospective, randomized controlled trial to evaluation the ability of 5-aminolevulinic acid HCL topical solution photodynamic therapy to decrease the colonization of Cutibacterium acnes (C. acnes- a bacteria commonly found in the dermis of the skin surrounding the shoulder) in order to decrease postoperative joint infections. -Aminolevulinic acid (ALA) is a naturally occurring metabolite in the synthesis of pathway of cellular heme production. Adding ALA to bacteria encourages porphyrin production which serve as the immediate precursors to heme production. When these porphyrins are illuminated with blue light at an emission peak of 407-420nm, these metabolites become exothermic and cause internal destruction of the bacterial cells. This therapy does not cause any damage to the mammalian cells, which makes PDT safe for human skin treatment.

Official Title
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Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis

Conditions
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C. Acnes, Phototherapy, Postoperative Infection, Arthroscopic Rotator Cuff Repair, Shoulder Surgery

Intervention / Treatment
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* Procedure: Skin Biopsy
* Drug: 5 Aminolevulinic Acid + Phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All male patients (>18) undergoing shoulder arthroscopy) Exclusion Criteria: Female patients Patients with active acnes Patients who have taken antibiotics within a month of their surgery Subjects with psoriatic/eczematous lesions on the shoulder girdle Patients on anticoagulant therapy Patients who have a known allergy to any of the agents used in the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Phototherapy Group<br>patient will be instructed to apply 5-aminolevulinic acid HCL topical solution to their shoulder prior to their surgery. 16 minutes before skin incision a blue light will be applied to the area of the shoulder where the 5-ALA was administered | Procedure: Skin Biopsy<br>* A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis<br>Drug: 5 Aminolevulinic Acid + Phototherapy<br>* 5 aminolevulinic acid solution will be placed on the skin of the shoulder and the participant will receive Photodynamic therapy on the morning of surgery<br>|
| Active Comparator: Group 2: Control Group<br>patient will undergo standard of care surgery | Procedure: Skin Biopsy<br>* A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of patients who have microbiological results positive for the bacteria C. acnes after treatment with 5-aminolevulinic acid-photodynamic therapy (ALA-PDT) versus those who were not. |  | 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease Rate of Postoperative Infection | The change in the incidence of postoperative shoulder infections in participants treated with photodynamic therapy versus participants who were not | 3 months |