Arthroscopic Rotator Cuff Repair, C. Acnes, Phototherapy, Postoperative Infection, Shoulder Surgery
Conditions
Brief 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.
Interventions
PROCEDURESkin Biopsy
A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis
DRUG5 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
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 13 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease Rate of Postoperative Infection | 3 months | The change in the incidence of postoperative shoulder infections in participants treated with photodynamic therapy versus participants who were not |
Countries
United States
Outcome results
None listed