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Triamcinoloneimpregnated nasal dressing following endoscopic sinus surgery: a randomized, doubleblind, placebocontrolled studyRhinological and Otological Society, Inc.
Triamcinolone-Impregnated Nasal DressingFollowing Endoscopic Sinus Surgery: ARandomized, Double-Blind, Placebo-Controlled Study David W. J. Coˆte´, MD, MPH; Erin D. Wright, MD CM, MEd Objectives/Hypothesis: To evaluate the impact the groups at 3- and 6-month observations (Lund- of steroid-impregnated absorbable nasal dressing on Kennedy, P ¼ .007 and P ¼ .02, respectively; POSE, P wound healing and surgical outcomes after endoscopic ¼ .049 and P ¼ .01, respectively).
Conclusions: Data analysis suggests a signifi- Study Design: A prospective, randomized, dou- cant improvement in early postoperative healing in ble-blinded, placebo-controlled trial.
nasal cavities receiving triamcinolone-impregnated Methods: Chronic rhinosinusitis patients with absorbable nasal packing following ESS and is also polyposis who were to undergo bilateral endoscopic associated with improved healing up to 6 months sinus surgery were recruited and randomized to dressing (Nasopore; Stryker Canada, Hamilton, On- tario, Canada) in one nasal cavity and saline-impreg- nated dressing contralaterally. Postoperative healing assessments of edema, crusting, secretions, and scar-ring were done at postoperative days 7, 14, 28 and at3 and 6 months using validated Lund-Kennedy and Perioperative Sinus Endoscopy (POSE) scores.
Since its advent in the 1980s, endoscopic sinus sur- Results: Analysis of 19 enrolled patients having gery (ESS) has replaced antrostomies and Caldwell-Luc completed observation shows no significant differencebetween the cavity scores preoperatively using both procedures as the treatment of choice for intractable rhi- the POSE and Lund-Kennedy scores. There was, how- nosinustits.1 Wound healing is a significant determinant ever, a statistically significant difference at day 7 and of successful outcomes in endoscopic sinus surgery. Fac- 14 in both the Lund-Kennedy (P ¼ .04 and P ¼ .03, tors that can lead to poor surgical outcomes include respectively) and POSE scores (P ¼ .03 and P ¼ .001, scarring/synechiae, ostial or middle meatal obstruction, respectively) for the treatment and control groups, infection, and persistent inflammation in the opened and a significant difference was also detected between sinus cavities. Although there exists some debate as tooptimal postoperative stenting or dressing materials fol-lowing ESS, absorbable nasal dressing has been shown From the Division of Otolaryngology, Head and Neck Surgery, University of Alberta, Edmonton, Alberta, Canada.
in previously published literature to trend toward Editor’s Note: This Manuscript was accepted for publication Feb- improved wound healing and was subjectively preferred by patients when compared to standard nasal sponges.2,3 This article has been awarded the Shirley Baron Resident Topical steroids used preoperatively have been eval- Research Award, Western Section, and was presented at the TriologicalSociety Combined Sections Meeting, Orlando, Florida, U.S.A., February uated and showed a lesser rate of bacterial recovery, again suggesting a beneficial role to postoperative out- Investigator-initiated study with Nasopore dressings donated by comes.4 Intranasal triamcinolone acetonide has been Stryker Canada. Stryker Canada had no involvement in study design,protocol, methods, or analysis. The authors have no other funding, finan- evaluated in clinical trials and found to be beneficial in cial relationships, or conflicts of interest to disclose.
minimizing nasal secretory response, reducing inflam- Send correspondence to David W. J. Coˆte´, MD, MPH, Chief Resi- mation in medical treatment of rhinosinusitis. In a risk- dent, c/o Division of Otolaryngology, Head and Neck Surgery, Universityof Alberta, 1E4 Walter McKenzie Centre, 8440-112 Street NW, Edmon- benefit analysis, it has been associated with markedly ton, Alberta, Canada T6G 2B7. E-mail: email@example.com cote@ few adverse side effects.4 As such, The International Consensus Conference Proceedings on Rhinitis recom- mend intranasal steroids as a first line therapy in Coˆte´ and Wright: Triamcinolone-Impregnated Nasal Dressing Fig. 1. Perioperative Sinus Endoscopy (POSE)score.
allergic rhinosinusitis.5 However, in the postoperative there is value to a course of postoperative systemic ste- time frame, the use of topical corticosteroid sprays, in an roids but no strong evidence that topical steroids in a effort to prevent recurrence of chronic rhinosinusitis spray delivery system is beneficial. Based on this litera- with polyposis, has met with mixed results.6 A relatively ture and logic, we hypothesized that a more prolonged recent, well-designed study showed no impact on recur- and direct delivery of topical steroids in the immediate rence rates in such patients at 1 year postoperatively. In postoperative time frame might be able to achieve the addition, it has been previously suggested that the use improved objective/endoscopic appearance achieved with of nasal packs to deliver topical antibiotics in the postop- systemic steroids. This study, therefore, sought to assess the potential benefit of impregnating an absorbable What has been demonstrated to be of clinically sig- nasal dressing with a topical steroid solution, for use as nificant effect on objective surgical outcomes after ESS a slow-delivery modality after sinus surgery, which had is a short course of systemic steroids given periopera- yet to be evaluated in a clinical trial.
tively.8 A randomized, double-blind, placebo-controlledstudy, in which patients were given 30 mg of prednisonefor 9 days postoperatively, showed a clinically significant improvement in the endoscopic appearance of the sino- A prospective, randomized, double-blinded, placebo-con- nasal cavity in the short (2–4 weeks) and medium term rhinosinusitis with polyposis who underwent bilateral ESS.
Patients were recruited in a subspecialized rhinology clinic As discussed above, there remains a lack of consen- among patients with chronic rhinosinusitis with polyposis re- sus regarding optimal perioperative nasal dressing and fractory to medical treatment requiring bilateral sinus surgery.
packing as well as the optimal postoperative medical Consecutive adult patients with chronic rhinosinusitis were regimen. Evidence-based practice would suggest that approached for inclusion. Patients were excluded if they were Coˆte´ and Wright: Triamcinolone-Impregnated Nasal Dressing Perioperative Sinus Endoscopy Scores.
POSE ¼ Perioperative Sinus Endoscopy scores.
ineligible for informed consent, unwilling or unable to complywith the postoperative visits necessary for data collection, or had any history of intolerance to triamcinolone. Ethics approvalwas obtained from the Human Research Ethics Board of theUniversity of Alberta, study ID# Pro00002016. Of the patients patients missed one or two of the postoperative clinic approached for recruitment, there were no patients declining appointments. No adverse side effects were noted in the Baseline Lund-Mckay, Perioperative Sinus Endoscopy A statistically significant difference is noted at the (POSE), and Lund-Kennedy scores were collected.8–10 These day 7 and 14 values in both the Lund-Kennedy (P ¼ .04 objective endoscopic scoring systems for sinonasal cavities and P ¼ .03, respectively) and POSE scores (P ¼ .03 and include assessments of features such as crusting, mucosal P ¼ .001, respectively) for the treatment and control edema, polyposis, secretions, and scarring (Lund-Kennedy, two groups. The difference lacked statistical significance points for each category), as well as additional assessments of at postoperative day 28 (Lund-Kennedy, P ¼ .13; POSE, the middle turbinate, middle meatal antrostomy, and secondary P ¼ .27), but a significant difference was detected sinuses (POSE). The POSE scoring system has been specificallydeveloped for studies such as this, adds additional data richness between the groups at 3 and 6 month observations in the ethmoid inflammation category, and includes scoring (Lund-Kennedy, P ¼ .007 and P¼ .02, respectively; instructions for the baseline assessment (Fig. 1).8 POSE, P ¼ .049 and P ¼ .01, respectively) (see Table II At the conclusion of the ESS, the patient was randomized to either the left or right nasal cavity to receive 2 mL of a 40-mg/mL triamcinolone solution-impregnated bioresorbable (4 cm)dressing (Nasopore; Stryker Canada, Hamilton, Ontario, Can-ada), whereas the contralateral cavity received an identical 4- cm dressing soaked in 2 mL of normal saline. This was done by Success in outcomes of ESS in patients with chronic the nursing staff, based on standardized instructions and con- rhinosinusitis with polyposis is heavily dependant on cealed from the surgical staff. The primary investigator left the reducing postoperative scarring, edema, and crusting room and nasal packing was placed in appropriate cavities that can inhibit natural ciliary function and sinus drain- according to the randomization. Nasal packing remained in situ age. To this end, many rhinologists advocate aggressive until suctioned from middle meatus at the first postoperative use of saline irrigation and nasal steroid sprays postop- visit 1 week later. Randomization allocation was placed in an eratively along with meticulous debridement of the envelope and remained sealed until all postoperative data was ethmoid cavities and secondary sinus outflow tracts.
With this practice, incidence of synechiae formation in Postoperative healing assessments of edema, crusting, secretions, and scarring were done at postoperative days 7, 14, the nasal cavity is lessened. A separate evaluation of the 28 and at 3 and 6 months using validated Lund-Kennedy and synechia data from the POSE and Lund-Kennedy scores POSE scores. Patients were all to resume their nasal saline irri- was performed. Synechiae were rare in both the treat- gation and intranasal steroid sprays postoperatively per routine ment and control groups; there was a trend to less synechia formation in the cavities assigned to the treat- Sample size was calculated based on previously published ment group, but the data lacked statistical significance literature using the POSE scoring system with a standard devi- ation of 3.43 as seen for a similar group of patients, with an aof 5% and a power of 80% to detect a difference in meansbetween populations of 3.5, which was felt to be clinically rele- vant. The calculated sample size was 32 surgical cavities (16 patients) with patients serving as their own controls. Statistical analysis was performed using the Wilcoxon signed rank test using a significance level of P < .05.
Nineteen patients were enrolled through the rhinol- ogy clinic at the Alberta Sinus Centre and completed observation. Analysis of the preoperative POSE, Lund-Kennedy, and Lund-Mckay score shows no significant difference between the cavities (see Table I). Some Coˆte´ and Wright: Triamcinolone-Impregnated Nasal Dressing Although Nasopore as a biologically inert absorbabledressing was an effective choice for slow delivery in themiddle meatus, one study suggested that it may be associ-ated with a slight delay in healing when compared toMerocel (Medtronic Merocel, Mystic, CT).15 Additionally,the ideal dosing remains to be clarified to achieve maxi-mal clinical benefit using this method. These are bothareas of future investigation. This practice-modifyingresult has led us to reflect on further potential targets ofthis postoperative concept. Examples of this include therole for triamcinolone-impregnated packing in postsur-gery recurrence of sinonasal inflammation and polyposisand stenting of the sphenoid ostium or frontal recess aftersurgery, which has yet to be established. Such innovations Fig. 2. Perioperative Sinus Endoscopy (POSE) and Lund-Kennedy are likely to become commonplace in the next several scores postoperatively in the treatment and control groups. POD¼ postoperative day. [Color figure can be viewed in the online years as biomaterials and pharmacology of same contin- issue, which is available at www.interscience.wiley.com.] Perioperative systemic steroids have also been pro- posed as an adjuvant to topicals to reduce recurrence of edema and polyposis, but liberal use has been limited by The results of this study reveal a significant improve- the side effect profile of systemic steroids. A previously ment in early postoperative healing in sinonasal cavities published study evaluating 30 mg of perioperative pred- receiving triamcinolone-impregnated absorbable nasal nisone found a difference in cavities of treatment packing following ESS and is also associated with signifi- patients up to 6 months postoperatively when compared cantly improved healing up to 6 months postoperatively.
to the nasal cavities of controls, with the most signifi-cant difference noted at 2 weeks postoperatively.8 The present study presents a perfectly matched, 1. Lazar RH, Younis RT, Long TE. Functional endonasal sinus double-blinded, placebo-controlled trial that demonstrates surgery in adults and children. Laryngoscope 1993;103: that a bioresorbable sinonasal dressing soaked in triamcin- olone, when used as an adjuvant to saline irrigation and 2. Wormald PJ, Boustred RN, Le T, Hawke L, Sacks R. A pro- conventional topical steroid sprays, is associated in a stat- spective single-blind randomized controlled study of useof hyaluronic acid nasal packs in patients after endo- istically and clinically significant fashion with improved scopic sinus surgery. Am J Rhinol 2006;20:7–10.
objective sinonasal cavity findings up to 6 months postop- 3. Franklin JH, Wright ED. Randomized, controlled, study of eratively (see Fig. 2). These significant improvements, in absorbable nasal packing on outcomes of surgical treat- both established objective outcome measures (Lund-Ken- ment of rhinosinusitis. Am J Rhinol 2007;21:214–217.
nedy and POSE), combined with the benign side effect 4. Desrosiers M, Hussain A, Frenkiel S, et al. Intranasal corti- costeroid use is associated with lower rates of bacterial profile of topical triamcinolone compared to systemic ste- recovery in chronic rhinosinusitis. Otolaryngol Head roids, has led to a change in standard practice at our institution whereby all chronic rhinosinusitis patients with 5. Gawchik SM, Saccar CL. A risk-benefit assessment of intra- polyposis routinely receive this nasal dressing impregnated nasal triamcinolone acetonide in allergic rhinitis. DrugSaf 2000;23:309–322.
6. Dijkstra MD, Ebbens FA, Poublon RM, Fokkens WJ. Fluti- Previous studies have attempted to address the chal- casone proprionate aqueous nasal spray does not influ- ence the recurrence rate of chronic rhinosinusitis and formation by application of topical antiproliferative nasal polyps 1 year after functional endoscopic sinus sur- agents.11,12 Although these attempts have, in some cases, gery. Clin Exp Allergy 2004;34:1395–1400.
7. Shikani AH. Use of antibiotics for expansion of the Merocel demonstrated limited success, limitations of study design packing following endoscopic sinus surgery. Ear Nose and follow-up, as well as concerns regarding toxicity and long-term deleterious effects such as malignancies, 8. Wright ED, Agrawal S. Impact of perioperative systemic remand this practice out of the mainstream. In addition, a steroids on surgical outcomes in patients with chronicrhinosinusitis with polyposis: evaluation with the novel recent systematic review demonstrated little value in perioperative sinus endoscopy (POSE) scoring system.
other wound-healing modifiers, such as retinoic acid or Laryngoscope 2007;117(11 pt 2 suppl 115):1–28.
hyaluronic acid, after ESS.13 One animal study using a 9. Lund VJ, Kennedy DW. Staging for rhinosinusitis. Otolar- sheep mucosal model found no difference in epithelializa- yngol Head Neck Surg 1997;117:S35–S40.
10. Lund VJ, Mackay IS. Staging in rhinosinusitis. Rhinology impregnated with prednisolone.14 The present study 11. Konstantinidis I, Tsakiropoulou E, Vital I, Triaridis S, Vital offers an alternative to these agents that provides evi- V, Constantinidis J. Intra- and postoperative application dence of overall improved surgical outcomes, including of Mitomycin C in the middle meatus reduces adhesions measures of edema, crusting, secretions, and scarring.
and antrostomy stenosis after FESS. Rhinology 2008;46:107–111.
Limitations to our study include the likely variable 12. Anand VK, Tabaee A, Kacker A, Newman JG, Huang C.
consistency and duration of delivery of the triamcinolone.
The role of mitomycin C in preventing synechia and Coˆte´ and Wright: Triamcinolone-Impregnated Nasal Dressing stenosis after endoscopic sinus surgery. Am J Rhinol 15. Shoman N, Gheriani H, Flamer D, Javer A. Prospective, 13. Weitzel EK, Wormald PJ. A scientific review of middle mea- tal packing/stents. Am J Rhinol 2008;22:302–307.
biodegradable synthetic polyurethane foam (NasoPore) as 14. Robinson S, Adams D, Wormald PJ. The effect of nasal packing and prednisolone on mucosal healing and recilia- sinus surgery. J Otolaryngol Head Neck Surg 2009;38: tion in a sheep model. Rhinology 2004;42:68–72.
Coˆte´ and Wright: Triamcinolone-Impregnated Nasal Dressing
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