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

NCT04636242 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-11-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636242 on ClinicalTrials.gov