Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Sinusitis Drug: Amoxicillin-Potassium Clavulanate Drug: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : February 2013
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.



Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919411


Locations
Layout table for location information
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Layout table for investigator information
Principal Investigator: Eric H Holbrook, MD MEEI
  Study Documents (Full-Text)

Documents provided by Eric Holbrook, Massachusetts Eye and Ear Infirmary:
Study Protocol  [PDF] October 6, 2014
Statistical Analysis Plan  [PDF] January 28, 2020


Publications:
Layout table for additonal information
Responsible Party: Eric Holbrook, Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01919411    
Other Study ID Numbers: 11-053H
First Posted: August 9, 2013    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eric Holbrook, Massachusetts Eye and Ear Infirmary:
Chronic rhinosinusitis
Sinus surgery
Antibiotics
Additional relevant MeSH terms:
Layout table for MeSH terms
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action