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Trial record 15 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures

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ClinicalTrials.gov Identifier: NCT02413034
Recruitment Status : Completed
First Posted : April 9, 2015
Results First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Pérez Prieto, Parc de Salut Mar

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Prosthetic Joint Infection
Interventions Drug: Cefazolin
Other: Control group
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Study Group
Hide Arm/Group Description No antibiotic prophylaxis Cefazolin: Cefazolin (vancomycin in the case of allergy to cefazolin)
Period Title: Overall Study
Started 14 14
Completed 14 14
Not Completed 0 0
Arm/Group Title Control Group Study Group Total
Hide Arm/Group Description No antibiotic prophylaxis Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin) Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
   7.1%
2
  14.3%
3
  10.7%
>=65 years
13
  92.9%
12
  85.7%
25
  89.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
74  (12) 75  (12) 74  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
10
  71.4%
11
  78.6%
21
  75.0%
Male
4
  28.6%
3
  21.4%
7
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 14 participants 14 participants 28 participants
14 14 28
1.Primary Outcome
Title Positive Cultures
Hide Description Number of positive Tissue Cultures (7)
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Study Group
Hide Arm/Group Description:
No antibiotic prophylaxis
Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: cultures
7 7
2.Primary Outcome
Title Sonication Cultures
Hide Description Number of positive Sonication cultures (7)
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Study Group
Hide Arm/Group Description:
No antibiotic prophylaxis
Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: cultures
7 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Study Group
Hide Arm/Group Description No antibiotic prophylaxis Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
All-Cause Mortality
Control Group Study Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Study Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Study Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Pérez-Prieto
Organization: Hospital del Mar
Phone: 0034932483196
EMail: dperezprieto@hospitaldelmar.cat
Layout table for additonal information
Responsible Party: Daniel Pérez Prieto, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02413034     History of Changes
Other Study ID Numbers: 2014/5533/I
First Submitted: March 24, 2015
First Posted: April 9, 2015
Results First Submitted: March 28, 2016
Results First Posted: August 3, 2016
Last Update Posted: August 3, 2016