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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000674831
Enrollment
50
Registered
2021-06-03
Start date
2023-05-25
Completion date
2024-09-17
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Sponsors

Dr. Andrew James Wood
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 9, 2026