Health TrialsbyHealthPanel

Comparative Analysis of Silastic Stenting in Sinus Surgery

ConditionChronic Rhinosinusitis (Diagnosis)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-89
SponsorUniversity of British Columbia

About this trial

Silastic stenting is a measure taken to support tissue healing following sinus surgery. Silastic stents are inserted into the sinus cavities and provide structural support while facilitating healing in the critical period of recovery following surgery. There is controversy over the optimal duration for which silastic stents should be left in place. Having them in place for shorter periods may reduce the likelihood of stent-related reactions, while leaving them for longer periods could promote more tissue healing. The aim of this study is to compare the impact of stent duration on clinical outcomes of patients following sinus surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with chronic rhinosinusitis requiring Frontal drill-out.

Disqualifiers

Patients unwilling or unable to comply with the study protocol.

Previous Radiotherapy to operated area.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Silastic Stenting

    Procedure/Surgery

    Drill-out frontal sinus procedures, are a well-established surgical intervention in the management of CRS, involves extensive sinus surgery with the creation of a large, surgically exposed area of raw bone. This raw bone, left exposed postoperatively, poses a unique challenge in the context of mucosal healing. Silastic stents, inserted into the sinus cavities, offer a promising solution by providing structural support and facilitating mucosal re-mucolisation in this critical period of postoperative recovery.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Short-term (4 weeks) Silastic StentingExperimental treatment 1 intervention
Group B: Long-term (12 weeks) Silastic StentingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Long-Term Patency

Patency is to be assessed by using the validated scoring system from Lund VJ, Kennedy DW. Quantification for staging sinusitis. In: Kennedy DW, editor. International Conference on Sinus Disease: Terminology, Staging, Therapy. Ann Otol Rhinol Laryngol 1995; 104(Suppl 167):17-21.

Time frame
6 and 18 months
2

Incidence of acute sinus infection

The occurrence and frequency of acute sinusitis in both cohorts, requiring rescue course of oral antibiotics.

Time frame
2 and 4 weeks

Secondary outcomes

1

Tolerability Assessment

Instrument: Likert Scale

Time frame
At the respective stent extraction time
2

Symptom Relief Assessment

Instrument: Sinonasal Outcome Test-22 (SNOT-22)

Time frame
6 and 18 months post-op

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Addenbrooke's Hospital, Cambridge University

Collaborator

NHS Greater Glasgow and Clyde

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: