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Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Eric Holbrook, Massachusetts Eye and Ear Infirmary
Sponsor:
Information provided by (Responsible Party):
Eric Holbrook, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01919411
First received: August 1, 2013
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
Surgeons commonly prescribe post operative prophylactic antibiotics after sinus surgery. There is minimal data to support this. The investigators' study will aim to demonstrate that patients' quality of life and rate of post operative infection is the same whether they receive or do not receive antibiotics post operatively. The investigators hypothesis is that the disease specific quality of life of patients taking post-operative antibiotics is not inferior to the quality of life of patients who do not take post-operative antibiotics, and the rate of post-operative infections are the same. The investigators' specific aim is to compare validated symptom scores between post-operative populations who are given or are not given antibiotics. Rates of infections in the first 10 days after surgery will be recorded. The investigators will also compare endoscopic grades of sinus cavities during the post-operative follow up exams as an additional outcome measure.

Condition Intervention Phase
Sinusitis Drug: Amoxicillin-Potassium Clavulanate Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Eric Holbrook, Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Sinonasal outcome test - 22 [ Time Frame: One week post operatively ]
    The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis.

  • Sinonasal outcome test - 22 [ Time Frame: Six weeks post operatively ]
    The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis.


Secondary Outcome Measures:
  • Lund Kennedy Endoscopic Score [ Time Frame: One week postoperatively ]
    The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting).

  • Lund Kennedy Endoscopic Score [ Time Frame: Six weeks postoperatively ]
    The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting).


Other Outcome Measures:
  • Rate of post operative infection [ Time Frame: One week postoperatively ]
    The investigators will record the rate of post operative infections in the two groups.

  • Rate of post operative infection [ Time Frame: Six weeks postoperatively ]
    The investigators will record the rate of post operative infections in the two groups.


Estimated Enrollment: 140
Study Start Date: February 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amoxicillin-Potassium Clavulanate
All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.
Drug: Amoxicillin-Potassium Clavulanate
Patients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery.
Other Name: Augmentin
Placebo Comparator: Placebo
All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Drug: Placebo
Patients in this arm will receive 7 days of placebo after surgery.

Detailed Description:
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the United States to treat chronic rhinosinusitis. Common practice is to prescribe prophylactic antibiotics postoperatively. This is similar to the long tradition of prophylactic antibiotics after tonsillectomy. The American Academy of Otolaryngology - Head and Neck Surgery recently strongly recommended against prophylactic antibiotics after tonsillectomy. In this light, this study would demonstrate the lack of need for antibiotics after FESS. Currently one surgeon does not prescribe antibiotics except when evidence of active infection was found during surgery. The other surgeon in the study currently prescribes antibiotics. This study would prospectively compare the two groups in a randomized fashion. The investigators' plan to use the Sinonasal outcomes test - 22 (SNOT-22) as the investigators' primary outcomes measure, which is a validated quality of life instrument in sinusitis.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients eligible for surgery would be patients with chronic rhinosinusitis (defined by the AAOHNS 2007 consensus statement by Rosenfeld et al) and have been determined by their surgeons to have persistent symptoms after maximal medical therapy. Maximal medical therapy is defined as a course of broad spectrum or culture-directed antibiotics used in conjunction with a nasal steroid.

Exclusion Criteria:

  1. Penicillin, cephalosporin, amoxicillin/clavulanate allergy
  2. Cystic Fibrosis
  3. Immunodeficiency
  4. Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery
  5. Odontogenic causes of sinusitis
  6. Fungal ball
  7. Infected mucocele
  8. Complication of sinusitis (meningitis, orbital complication, cellulitis, brain abscess)
  9. Non endoscopic sinus surgery (Caldwell luc, external approaches, etc)
  10. Age <18
  11. Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919411

Contacts
Contact: Eric Holbrook, MD 617 573 3209 eric_holbrook@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eric Holbrook, MD    617-573-3209    eric_holbrook@meei.harvard.edu   
Principal Investigator: Eric Holbrook, MD         
Sub-Investigator: Stacey T Gray, MD         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Eric H Holbrook, MD MEEI
  More Information

Publications:
Responsible Party: Eric Holbrook, Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01919411     History of Changes
Other Study ID Numbers: 11-053H
Study First Received: August 1, 2013
Last Updated: April 3, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Eric Holbrook, Massachusetts Eye and Ear Infirmary:
Chronic rhinosinusitis
Sinus surgery
Antibiotics

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Clavulanic Acid
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 22, 2017