ActivePhase 4ACTRN12621000674831

Doxycycline after sinus surgery

A multi-centre randomised controlled trial of post-operative doxycycline assessing recovery in patients undergoing endoscopic sinus surgery for the treatment of chronic rhinosinusitis


Sponsor

Dr. Andrew James Wood

Enrollment

50 participants

Start Date

May 25, 2023

Study Type

Interventional

Conditions

Summary

Endoscopic Sinus Surgery (ESS) is one of the most commonly performed elective surgical procedures in the Western world. A prior study in 2015 (Valdez et al. Current trends in preoperative antibiotic use: A survey of Otolaryngologists) reported that 73% of ENT Surgeons reported use of peri-operative antibiotics in ESS. Antibiotic resistance has been described by the World Health Organisation (WHO) as “one of the biggest threats to global health” and is accelerated by misuse of antibiotics. Data to rationalise or discourage the use of antibiotics are therefore urgently required. The initial aim of the pilot study was to facilitate this larger study to clarify the role of oral antibiotics in this setting. Despite their widespread use in this context, the pilot study has suggested that oral antibiotics may in fact be inferior to placebo in this context. Ultimately this study therefore has the capacity to either rationalise or prevent the use of many millions of antibiotic scripts across the World and potentially generate improved post-ESS outcomes for patients.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Inclusion Criteria1

  • Patient undergoing Bilateral Comprehensive Endoscopic Sinus Surgery for the treatment of chronic rhinosinusitis as defined by the European Position Statement, 2020

Exclusion Criteria3

  • Prior sinus surgery
  • Predisposing condition (e.g. Aspirin exacerbated respiratory disease, Granulomatosis with Polyangitis, Cystic fibrosis)
  • Antibiotic usage in the 4 weeks prior to recruitment.

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Interventions

Doxycycline 100mg tablets by mouth twice daily for 2 weeks, commencing on the morning after surgery. Patients will be asked to return any unused tablets to monitor adherence.

Doxycycline 100mg tablets by mouth twice daily for 2 weeks, commencing on the morning after surgery. Patients will be asked to return any unused tablets to monitor adherence.


Locations(1)

New Zealand

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