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

• 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: Massachusetts Eye and Ear Infirmary
• Information provided by (Responsible Party): Eric Holbrook, Massachusetts Eye and Ear Infirmary

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary

Investigators

• 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

More Information

Publications:

Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.

Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ, Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith TL, Witsell DL. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3 Suppl):S1-31.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lehmann AE, Raquib AR, Siddiqi SH, Meier J, Durand ML, Gray ST, Holbrook EH. Prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis: a randomized, double-blind, placebo-controlled noninferiority clinical trial. Int Forum Allergy Rhinol. 2021 Jul;11(7):1047-1055. doi: 10.1002/alr.22756. Epub 2020 Dec 19.

• 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
• 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:

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; 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