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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01919411
Recruitment Status : Completed
First Posted : August 9, 2013
Results First Posted : February 10, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Eric Holbrook, Massachusetts Eye and Ear Infirmary

Tracking Information
First Submitted Date  ICMJE August 1, 2013
First Posted Date  ICMJE August 9, 2013
Results First Submitted Date  ICMJE January 28, 2020
Results First Posted Date  ICMJE February 10, 2020
Last Update Posted Date February 25, 2020
Study Start Date  ICMJE February 2013
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • 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. Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms.
  • 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. Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • 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). Scores range from 0 to 20 with higher scores indicating greater sinus disease.
  • 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). Scores range from 0 to 20 with higher scores indicating greater sinus disease.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
  • 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).
Current Other Pre-specified Outcome Measures
 (submitted: February 17, 2020)
  • Number of Participants With Post Operative Infection [ Time Frame: One week postoperatively ]
    The investigators will record the rate of post operative infections in the two groups.
  • Number of Participants With Post Operative Infection [ Time Frame: Six weeks postoperatively ]
    The investigators will record the rate of post operative infections in the two groups.
Original Other Pre-specified Outcome Measures
 (submitted: August 8, 2013)
  • 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.
 
Descriptive Information
Brief Title  ICMJE Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial
Official Title  ICMJE Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sinusitis
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Patients in this arm will receive 7 days of placebo after surgery.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Amoxicillin-Potassium Clavulanate
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2018)
134
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2013)
140
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01919411
Other Study ID Numbers  ICMJE 11-053H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eric Holbrook, Massachusetts Eye and Ear Infirmary
Study Sponsor  ICMJE Massachusetts Eye and Ear Infirmary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric H Holbrook, MD MEEI
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP