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

• Status: Enrolling by invitation
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rothman Institute Orthopaedics
• Treatments: Aminolevulinic Acid

Criteria

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