Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis
Primary Purpose
C. Acnes, Phototherapy, Postoperative Infection
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Skin Biopsy
5 Aminolevulinic Acid + Phototherapy
Sponsored by
About this trial
This is an interventional prevention trial for C. Acnes
Eligibility 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
Sites / Locations
- Rothman Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1: Phototherapy Group
Group 2: Control Group
Arm Description
patient will be instructed to apply 5-aminolevulinic acid HCL topical solution to their shoulder prior to their surgery. 16 minutes before skin incision a blue light will be applied to the area of the shoulder where the 5-ALA was administered
patient will undergo standard of care surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04636242
First Posted
October 21, 2020
Last Updated
November 18, 2020
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04636242
Brief Title
Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis
Official Title
Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C. Acnes, Phototherapy, Postoperative Infection, Arthroscopic Rotator Cuff Repair, Shoulder Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Phototherapy Group
Arm Type
Experimental
Arm Description
patient will be instructed to apply 5-aminolevulinic acid HCL topical solution to their shoulder prior to their surgery. 16 minutes before skin incision a blue light will be applied to the area of the shoulder where the 5-ALA was administered
Arm Title
Group 2: Control Group
Arm Type
Active Comparator
Arm Description
patient will undergo standard of care surgery
Intervention Type
Procedure
Intervention Name(s)
Skin Biopsy
Intervention Description
A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis
Intervention Type
Drug
Intervention Name(s)
5 Aminolevulinic Acid + Phototherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Decrease Rate of Postoperative Infection
Description
The change in the incidence of postoperative shoulder infections in participants treated with photodynamic therapy versus participants who were not
Time Frame
3 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Women are being excluded because studies have shown that men have a higher bacterial burden of C. acnes than females. The male predisposition has been linked with the habitat of C. acnes being in the hair follicles and therefore the upper body of males would harbor more of the bacterium than females after shoulder surgery.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis
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