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

Rothman Institute Orthopaedics

Status and phase: Unknown; Phase 3

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

Treatments: Drug: 5 Aminolevulinic Acid + Phototherapy; Procedure: Skin Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04636242

SNAM19G.133

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Group 1: Phototherapy Group

Experimental group

Description:

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

Treatment:

Drug: 5 Aminolevulinic Acid + Phototherapy

Procedure: Skin Biopsy

Group 2: Control Group

Active Comparator group

Description:

patient will undergo standard of care surgery

Treatment:

Procedure: Skin Biopsy