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Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery

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ClinicalTrials.gov Identifier: NCT02764710
Recruitment Status : Unknown
Verified May 2016 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 6, 2016
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:
The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and augmentation surgery is unknown. This is a comparative open label interventional trial comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate with short antibiotic treatment for up to 24 hours postoperatively. The primary study outcome is the postoperative surgical site infection in the standard versus the short treatment arms. Secondary outcomes are drug-related adverse events and Clostridium difficile infection.

Condition or disease Intervention/treatment Phase
Maxillofacial Surgery Drug: Amoxicillin-Potassium Clavulanate Combination Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery
Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short treatment
Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.
Drug: Amoxicillin-Potassium Clavulanate Combination

Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.

Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7.


Active Comparator: Long treatment
Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7.
Drug: Amoxicillin-Potassium Clavulanate Combination

Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.

Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7.





Primary Outcome Measures :
  1. Surgical site infection rate [ Time Frame: 30 days ]
    Deep or superficial SSI according to CDC/NHSN criteria


Secondary Outcome Measures :
  1. Diarrhea [ Time Frame: 30 days ]
    Diarrheal illness reported by patient.

  2. Clostridium difficile infection [ Time Frame: 30 days ]
    Laboratory confirmed C. diff. infection

  3. Adverse event rate [ Time Frame: 30 days ]
    Any reported adverse event



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patient (18 years of age or older) that requires a unilateral or bilateral sinus augmentation surgery.
  2. Weight <150 kg.

Exclusion Criteria:

  1. Need for prophylactic antibiotics for infective endocarditis.
  2. Chronic antibiotics therapy.
  3. Special populations: pregnant women, minors and legally incompetent patients.
  4. Patients receiving anticoagulants.
  5. Non-balanced diabetes mellitus.
  6. Immune-suppression: corticosteroids treatment equivalent to 15mg prednisone for at least 14 days in the past month; chemotherapy, TNF inhibitor or drugs that suppress T-cell activity during the past 90 days; HIV infection.
  7. Pathology of the maxillary sinus.
  8. History of chronic sinusitis.
  9. Patients that underwent a Caldwell-Luc procedure.
  10. Patients with residual teeth roots at the planned surgical site.
  11. A known state of carriage of Methicillin resistant Staphylococcus aureus or Clostridium difficile in the past year.
Publications:
Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, Bolger A, Cabell CH, Takahashi M, Baltimore RS, Newburger JW, Strom BL, Tani LY, Gerber M, Bonow RO, Pallasch T, Shulman ST, Rowley AH, Burns JC, Ferrieri P, Gardner T, Goff D, Durack DT; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee; American Heart Association Council on Cardiovascular Disease in the Young; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Surgery and Anesthesia; Quality of Care and Outcomes Research Interdisciplinary Working Group. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2007 Oct 9;116(15):1736-54. Epub 2007 Apr 19. Erratum in: Circulation. 2007 Oct 9;116(15):e376-7.

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Responsible Party: michal roll, Head of Resaerch and Development Department, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02764710    
Other Study ID Numbers: TASMC-15-RB-0059-CTIL
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action