Clinical Trials Directory

Trials / Completed

CompletedNCT03115177

Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
Rush University Medical Center · Academic / Other
Sex
All
Age
40 Years – 90 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to investigate antibiotic treatment to target bacteria about the shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure of total shoulder arthroplasty as well as other shoulder surgeries. This study is investigating adding an FDA approved antibiotic that is commonly used for treatment of this bacteria and many common infections. The investigators will take intraoperative cultures to look for the presence or absence of specific bacteria. The investigators are conducting this trial to see if adding another antibiotic to specifically target this common bacteria found around the shoulder will be effective.

Detailed description

Patients undergoing total and reverse shoulder arthroplasty for primary glenohumeral arthritis will be invited to participate in this study if patients meet inclusion and exclusion criteria. Patients will be randomized to receive either standard perioperative antibiotics with cefazolin or to the treatment group to receive doxycycline in addition to cefazolin. Patients will then undergo routine surgical treatment. 3 cultures from the superficial tissue, dermis, and glenohumeral joint will be taken and cultured for 14 days to detect any bacterial growth.

Conditions

Interventions

TypeNameDescription
DRUGDoxycyclineThe treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.
DRUGCefazolin

Timeline

Start date
2015-11-01
Primary completion
2017-02-01
Completion
2017-02-01
First posted
2017-04-14
Last updated
2018-06-15
Results posted
2018-06-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03115177. Inclusion in this directory is not an endorsement.