NCT04636242

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Skin Biopsy	A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis
DRUG	5 Aminolevulinic Acid + Phototherapy	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

Timeline

• Start date: 2019-08-22
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2020-11-19
• Last updated: 2020-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study