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

Rothman Institute Orthopaedics120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

C. Acnes Phototherapy Postoperative Infection Arthroscopic Rotator Cuff Repair

Interventions

Skin BiopsyPROCEDURE

A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis

5 Aminolevulinic Acid + PhototherapyDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 13 days

Secondary Outcomes

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

Time frame: 3 months