Skip to content

A blinded randomized controlled trial on the efficacy of post surgical debridement of sinus cavities on wound healing following endoscopic sinus surgery.

A blinded randomized controlled trial on the efficacy of post surgical debridement of sinus cavities on wound healing following endoscopic sinus surgery.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000170921
Enrollment
40
Registered
2011-02-11
Start date
2010-11-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Chronic sinusitis affects up to 20% of the population with a significant impact on quality of life for the sufferer. Endoscopic sinus surgery is currently the treatment of choice for chronic rhinosinusitis which fails to respond to medical therapy. This usually involves a combination of oral antibiotics, oral and topical steroids, and saline irrigation of the nose. The main complaint which patients have from this type of surgery is the discomfort and pain associated with debridement of the sino-nasal cavity following surgery. The main cause of failure of this surgery which may require revision surgery is poor wound healing with the formation of excess scar tissue in the form of bands between sides of the nose, called adhesions. Regular wound debridement to achieve the best outcomes following ESS has been strongly advocated, but the basis is largely empirical. Experts in the field have called for regular cavity debridement. There is no standardized regime for post operative care amongst ESS surgeons. In some cases debridement as frequently as daily during the early healing phase has been used. Weekly debridement for the first few weeks until healing occurs is still commonly employed. Sinus cavity debridement is uncomfortable and unpleasant for patients. It requires regular visits to the treating surgeon, with considerable cost implications on the patient and the health service. The literature as it stands is conflicting. There is only 1 pilot study investigating 17 pts in a non-blinded fashion. This pilot study demonstrated no significant difference in adhesions, however this was non-blinded and involved only 17 patients. There are studies that point to early debridement as key to limiting adhesion formation, whereas other studies show that minimal post-operative care is equally successful. The aim of this study is to ascertain whether early debridement, with its related costs and patient discomfort, limits adhesion formation as evaluated by a blinded observer, via video-endoscopy at 3 months post surgery.

Interventions

Debridement of randomised sinus cavity vs no debridement for contralteral sinus cavity This occurs after sinus surgery to clean the operated site from blood and crusts THIS OCCURS IN THE CLINIC. IT LASTS ABOUT 15 MINUTES. THE MECHANISM IS CLEANING BLOOD AND CRUSTS AS DISCUSSED ABOVE , WITH THE THOUGHT THAT THIS PREVENTS ADHESION FORMATION AND PAIN BUT THERE IS NO EVIDENCE THAT THIS WORKS - SEE BRIEF SUMMARY FIELD REGARDING THIS CLINICAL QUESTION AS REQUESTED.

Sponsors

Professor Wormald
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

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

Inclusion criteria

CRS not responsive to maximum medical therapy NO previous sinus surgery

Exclusion criteria

Sinus surgery for conditions other than CRS Immunological, or congenital predisposition to CRS

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026