Clinical trial · Interventional

Silastic Stent Study

The Effect of Silastic Stenting on Post-Operative Intra-Nasal Re-Mucosalization

NCT03282058CI-TRIAL-00029506unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Endoscopic skull base surgery is a relatively new procedure that is now a standard of care for surgeries at the base of the skull; however there are no studies that examine the healing process of the nasal lining with the use of silastic (silicone) stents (or splints) that might be placed at the time of surgery. While there is some evidence to suggest that the use of stents improves wound healing, the decision to use a stent or not is currently up to the preference of the surgeon. To investigate the impact of stents on post-surgical healing, the investigators at Vancouver General Hospital will compare patients undergoing trans-sphenoidal pituitary surgeries with septal flap reconstruction with the use of silastic stents to line the septal donor site, and compare their recovery to those who did not receive stents. The investigators hypothesize that the use of silastic stents in endonasal surgery increases the rate of mucosal healing, and better quality mucosal regeneration, and with no effect on the patients experience after surgery. In this randomized control trial the investigators aim to recruit 26 (13 in each arm) study participants. The primary outcome is to determine the effect of silastic stunting on healing of the naso-septal flap donor site. This objective will be achieved by assessment of endoscopic photographs of healing tissue and histologic assessment of healing tissues. The secondary outcome involves questionnaires that measure the patient's subjective nasal symptoms prior to and following endoscopic skull based surgery. Total time commitment for the study participant is about 4 months across 4 study visits (all of which are part of standard of care): the assessment visit, surgery, 4 weeks post-operative follow up visit and 12 week post-operative follow up visit.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pituitary Tumour	Pituitary Gland Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Silastic Stent	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Silastic Stent
description
At the time of surgery, if the patient is identified in the "silastic stent" arm, dressing of the septal donor site with silastic stents will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely.
interventionNames
1. Device: Silastic Stent
type
NO_INTERVENTION
label
No Stent
description
At the time of surgery, if the patient is identified in the "no silastic stent" arm, dressing of the septal donor site without the stent will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely - this is currently the standard of care.

Primary outcomes (5)

measure
Determining the effect of silastic stunting on gross level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion Criteria:

* patients undergoing trans-sphenoidal endoscopic pituitary surgery at their first post-operative appointment

Exclusion Criteria:

* patients with inflammatory sinus conditions
* patients having undergone extensive skull base reconstructions
* patients having received previous radiotherapy

References

Publications (5)

BACKGROUNDBednarski KA, Kuhn FA. Stents and drug-eluting stents. Otolaryngol Clin North Am. 2009 Oct;42(5):857-66, x. doi: 10.1016/j.otc.2009.07.001. PMID 19909864
BACKGROUNDCowin A, McIntosh D, Wormald PJ. Healing of wounds created in the nasal mucosa following endoscopic sinus surgery can be affected by different nasal packing materials. Primary Intention Vol. 10 No. 3 August 2002.
BACKGROUNDGamoletti R, Lanzarini P, Sanna M, Zini C. Regenerated middle ear mucosa after tympanoplasty. Part II. Scanning electron microscopy. Otolaryngol Head Neck Surg. 1986 Apr;94(4):430-4. doi: 10.1177/019459988609400404. PMID 3086802
BACKGROUNDNg M, Linthicum FH Jr. Long-term effects of Silastic sheeting in the middle ear. Laryngoscope. 1992 Oct;102(10):1097-102. doi: 10.1288/00005537-199210000-00002. PMID 1328786
BACKGROUNDSoper, D.S. (2014). A-priori Sample Size Calculator for Student t-Tests [Software]. Available from http://www.danielsoper.com/statcalc