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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing primary total shoulder arthroplasty at Rush University Medical Center

Exclusion criteria

Patients with prior shoulder surgery of any kind
Patients with a known infection or history of infection with clinical signs such as elevated erythrocyte sedimentation rate, C-reactive protein, positive culture aspiration
Patients with a known allergy to doxycycline
Patients with a known allergy to cefazolin or penicillin

Treatment and study plan

Doxycycline

Drug

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

Cefazolin

Drug

Primary outcomes

Bacterial Culture

Time frame: 2 weeks

Intraoperative cultures will be taken from all study participants and tested for detection of bacteria. These cultures were held for 14 days and tested for aerobic and anaerobic bacteria. Reported data are presented for the number of participants with a positive bacteria culture from the intraoperative samples.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Apr 14, 2017
Registry last updated: Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed