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

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ClinicalTrials.gov Identifier: NCT03115177
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Allison Rao, Rush University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Doxycycline Drug: Cefazolin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
Study Start Date : November 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017


Arm Intervention/treatment
Active Comparator: Cefazolin
All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The control group will not receive any further antibiotic treatment.
Drug: Cefazolin
Active Comparator: Doxycycline+Cefazolin Group
All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision.
Drug: Doxycycline
The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.

Drug: Cefazolin



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115177


Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Allison Rao, MD Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Allison Rao, Rush University Medical Center:
Study Protocol  [PDF] May 16, 2018
Statistical Analysis Plan  [PDF] May 16, 2018


Responsible Party: Allison Rao, Orthopaedic Surgery Resident, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03115177     History of Changes
Other Study ID Numbers: 15052002
First Posted: April 14, 2017    Key Record Dates
Results First Posted: June 15, 2018
Last Update Posted: June 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Doxycycline
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents