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NCT Number: NCT01919411

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Penicillin, cephalosporin, amoxicillin/clavulanate allergy
  • Cystic Fibrosis
  • Immunodeficiency
  • Presence of any foreign body (ie.absorbable and non-absorbable packing) after surgery
  • Odontogenic causes of sinusitis
  • Fungal ball
  • Infected mucocele
  • Complication of sinusitis (meningitis, orbital complication, cellulitis, brain abscess)
  • Non endoscopic sinus surgery (Caldwell luc, external approaches, etc)
  • Age <18
  • Pregnant women

Treatment and study plan

Amoxicillin-Potassium Clavulanate

Drug

Patients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery.

Other names: Augmentin

Placebo

Drug

Patients in this arm will receive 7 days of placebo after surgery.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2013
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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