An interventional study of Silastic Spacer and Merocel Spacer in Sinusitis, sponsored by St. Paul's Hospital, Canada. Completed at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by St. Paul's Hospital, Canada · Not applicable, Interventional, and Prevention
Functional endoscopic sinus surgery (FESS) is the best method of surgically treating patients who suffer from sinus disease. Synechiae formation in the nose is the most common complication after sinus surgery. Synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a silastic spacer is more effective at reducing the formation of synechiae after sinus surgery than a merocel spacer.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 313 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →St. Paul's Hospital, Canada is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
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This study arm receives the experimental treatment, a Silastic spacer.
Device: Silastic Spacer
Merocel spacers are actively being used as the standard of care.
Device: Merocel Spacer
The Silastic spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.
Also known as: Experimental Arm
The Merocel spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.
Also known as: Control Arm
Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.
The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported. Incidence of postoperative synechiae will be compared between right and left nasal cavities receiving either silastic or glove finger spacers.
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups.
The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence). A senior Rhinologist will endoscopically assess each nasal cavity independently to determine if synechiae exists between the middle turbinate and lateral nasal wall. Count and absolute percentages will be reported. Secondary comparisons of postoperative synechiae will be compared between subjects in the 6-day vs 14-day spacer removal groups.
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
Sinonasal Outcomes Test-22 (SNOT- 22) score.
The SNOT-22 is a sinus-specific questionnaire that evaluates subjective symptoms for patients suffering from chronic rhinosinusitis. SNOT-22 is scored out of 110 (22 questions, up to 5-points each) has demonstrated internal consistency, reliability, discriminate and concurrent validity and responsiveness to change12. Responses will be summated and considered as a continuous, numerical variable. Mean, median, standard deviation and inter-quartile range will be reported. SNOT-22 change between baseline (preoperative score) and 90-days (postoperative score) will be compared between groups having middle meatal spacers removed at 14 days versus 6 days postoperatively.
Time frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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St. Paul's Hospital, Canada