Trial Outcomes & Findings for Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty? (NCT NCT03115177)

Last Updated: 2018-06-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

2 weeks

Results posted on

2018-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	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. Cefazolin	Cefazolin and Doxycycline 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. Doxycycline: The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty. Cefazolin
Overall Study STARTED	27	29
Overall Study COMPLETED	27	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cefazolin n=27 Participants 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. Cefazolin	Doxycycline+Cefazolin Group n=29 Participants 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. Doxycycline: The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty. Cefazolin	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=27 Participants	0 Participants n=29 Participants	0 Participants n=56 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=27 Participants	10 Participants n=29 Participants	16 Participants n=56 Participants
Age, Categorical >=65 years	21 Participants n=27 Participants	19 Participants n=29 Participants	40 Participants n=56 Participants
Age, Continuous	69 years STANDARD_DEVIATION 8 • n=27 Participants	67 years STANDARD_DEVIATION 8 • n=29 Participants	68 years STANDARD_DEVIATION 8 • n=56 Participants
Sex: Female, Male Female	5 Participants n=27 Participants	2 Participants n=29 Participants	7 Participants n=56 Participants
Sex: Female, Male Male	22 Participants n=27 Participants	27 Participants n=29 Participants	49 Participants n=56 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	27 participants n=27 Participants	29 participants n=29 Participants	56 participants n=56 Participants
Body Mass Index	30 kg/m^2 STANDARD_DEVIATION 6 • n=27 Participants	30 kg/m^2 STANDARD_DEVIATION 6 • n=29 Participants	30 kg/m^2 STANDARD_DEVIATION 6 • n=56 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	Cefazolin n=27 Participants 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. Cefazolin	Cefazolin and Doxycycline n=29 Participants 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. Doxycycline: The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty. Cefazolin
Bacterial Culture	14 # Participants with Bacteria in Culture	15 # Participants with Bacteria in Culture

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Allison Rao

Rush University Medical Center

Phone: 608-445-0545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place