Interventional procedure overview of corticosteroid-releasing bioabsorbable stent or spacer insertion during endoscopic sinus surgery for chronic rhinosinusitis

Abd-Elmaksoud GA-E, Gouda MI, Khater KA (2019) Effect of steroid loaded middle meatal Gelfoam sheet on endoscopic sinus surgery outcome. The Egyptian Journal of Hospital Medicine 76: 4538–44

Randomised controlled trial

n=31(62 nasal cavities)

Follow up: 2 months

There was a statistically significant difference between the steroid side and the saline (control) side in reduction of synechia formation after ESS. Therefore, topical application of steroids is effective in minimising synechiae formation after ESS. It is also safe and no local or systemic complications were noted during the study.

Larger or more recent studies are included.

Adriaensen GFJPM Lim KH, Fokkens WJ (2017) Safety and efficacy of a bioabsorbable fluticasone propionate–eluting sinus dressing in postoperative management of endoscopic sinus surgery: a randomized clinical trial. Int Forum Allergy Rhinol. 7: 813–820

Randomised controlled trial

n=30

Follow up: 60 days

The dressing was well tolerated and showed evidence of efficacy. A larger study is needed to further evaluate and confirm the benefits.

Small study, which is included in the meta-analysis by Goshtasbi et al. (2019).

Brar T, Brown A, Miglani A et al. (2023) Outcomes of frontal sinus stenting with steroid impregnated microsponge versus steroid-eluting implant. American Journal of Rhinology & Allergy 37: 679–85

Retrospective non-randomised comparative study

n=68 (96 frontal sinus ostia; SES versus steroid impregnated microsponge)

Follow up: mean 249 days

For SNOT-22 scores, both cohorts were comparable in baseline scores and reduction from baseline.

Further studies may offer insights into specific circumstances where one stent may be preferable over the other stent.

Retrospective non-randomised study comparing 2 different types of implant.

Bury S and Singh A (2017) Evaluation of a steroid releasing sinus implant for the treatment of patients undergoing frontal sinus surgery for chronic rhinosinusitis, Expert Review of Medical Devices 14: 93–101

Review

4 trials

The studies to date have demonstrated that steroid-eluting implants are beneficial in reducing postoperative medical or surgical interventions for patients with chronic sinusitis undergoing ethmoid sinus surgery. The results in the frontal sinus are similar to data generated for ethmoid surgery with a decreased need for medical and surgical postoperative interventions.

A more recent systematic review and meta-analysis is included.

Campbell RG, Kennedy DW (2014) What is new and promising with drug-eluting stents in sinus surgery? Current Opinion in Otolaryngology & Head & Neck Surgery 22: 2-7

Review

2 RCTs, 1 prospective single-cohort study and a meta-analysis (of 2 studies)

Steroid-eluting implants are well tolerated and an effective addition to the armamentarium utilised in the management of chronic rhinosinusitis.

A more recent systematic review and meta-analysis is included.

Chang EH, Alandejani T, Akbari E et al. (2011) Double-blinded, randomized, controlled trial of medicated versus nonmedicated Merocel sponges for functional endoscopic sinus surgery. Journal of Otolaryngology - Head and Neck Surgery 40: S14–19

Randomised controlled trial

n=48 (96 nostrils, medicated versus non-medicated sponge)

Follow up: 7 days

The budesonide-soaked middle meatal spacers showed a trend toward reduced mucosal inflammation when compared to the control middle meatal spacers but the results were not statistically significant.

Larger or more recent studies are included.

Côté DWJ, Wright ED. (2010) Triamcinolone-impregnated nasal dressing following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled trial. Laryngoscope 120: 1269–73

Randomised controlled trial

n=19

Follow up: 6 months

Data analysis suggests a significant improvement in early postoperative healing in nasal cavities receiving triamcinolone-impregnated absorbable nasal packing following ESS and is also associated with improved healing up to 6 months postoperatively.

Larger or more recent studies are included.

Study is included in systematic review by Zhang et al. (2021).

Dautremont JF, Mechor B, Rudmik L. (2014) The role of immediate postoperative systemic corticosteroids when utilizing a steroid-eluting spacer following sinus surgery. Otolaryngology and Head and Neck Surgery 150: 689–95

Randomised controlled trial

n=36

Follow up: 2 months

Results from this study suggest that postoperative systemic corticosteroids immediately following endoscopic sinus surgery may not provide improved outcomes when using a steroid-eluting spacer.

Small study, assessing the role of oral corticosteroids after functional ESS with SES.

Forwith KD, Chandra RK, Yun PT et al. (2011) ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope 121: 2473 80

Prospective cohort

n=50 (90 treated sinuses)

Follow up: up to 6 months

The implant was associated with favourable rates of sinus patency. At 1 month, minimal degrees of inflammation and adhesions were observed.

More recent or larger studies are included.

Gershnabel Milk D, Lam KK, Han JK (2023) Corticosteroid-eluting implants for the management of chronic rhinosinusitis with or without nasal polyps. Expert Review of Clinical Immunology 19: 831–36

Review

Corticosteroid-eluting sinus implants allow the controlled application of corticosteroids directly to the involved sinuses over different time frames. The efficacy of the devices is supported by well-designed clinical trials.

Although not shown in the clinical trials, experience indicates that crusting around the stents, local infection, and facial pain are common, bothersome side effects, and are the leading cause of early removal of the stent. Although all patients are instructed to rinse the nose regularly, the stents are usually removed after 2 to 3 weeks because of crusting and discharge around them. This discrepancy between the clinical trials and real-world experience highlights the need to conduct more international, high-volume studies, to assess the prevalence of side effects and stent failures.

The corticosteroid-eluting sinus implant is an evolving, promising technology with clear clinical advantages and broad use. Still, a few issues need to be addressed and investigated.

No meta-analysis.

Grzeskowiak B, Wierzchowska M, Walorek R et al. (2019) Steroid vs. antibiotic impregnated absorbable nasal packing for wound healing after endoscopic sinus surgery: a randomized, double blind, placebo-controlled study. Brazilian Journal of Otorhinolaryngology 85: 473–80

Randomised controlled trial

n=80 (160 ethmoid cavities, steroid or antibiotic versus saline impregnated absorbable packing)

Follow up: 6 months

The results of this study reveal a statistically significant improvement of steroid and antibiotic impregnated biodegradable nasal packing influence on the postoperative healing process compared to saline soaked dressing. However, antibiotic impregnated packing demonstrated better advantage over the steroid dressing regarding patient comfort and satisfaction. Future investigations should be focused on the combination of both active drugs administered simultaneously in the ethmoid spaces.

Larger or more recent studies are included.

Study is included in systematic review by Zhang et al. (2021).

Han JK, Kern RC (2019) Topical therapies for management of chronic rhinosinusitis: steroid implants. International Forum of Allergy and Rhinology 9: s22–s26

Review

4 studies on SES implant during ESS, 2 studies on SES implant after ESS for recurrent nasal polyps

The results from the clinical studies showed that the use of the various steroid-eluting sinus implants can improve postoperative results after ESS as well as treat the recurrence of nasal polyps after sinus surgery without the need for additional sinus surgery.

The 4 relevant studies are included in the meta-analysis by Goshtasbi et al. (2019).

Han JK, Marple BF, Smith TL et al. (2012) Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. International Forum of Allergy & Rhinology 2: 271–9

Meta-analysis (2 studies)

n=143

According to the grading done by a panel, drug-releasing implants reduced postoperative interventions by 35% (p=0.0008), lysis of adhesions by 51% (p=0.0016), and oral corticosteroid need by 40% (p=0.0023), compared to controls. The relative reduction in frank polyposis was 46% (p<0.0001).

The 2 studies are included in the meta-analysis by Goshtasbi et al. (2019).

Hauser LJ, Turner JH, Chandra RK (2017) Trends in the use of stents and drug-eluting stents in sinus surgery. Otolaryngologic Clinics of North America 50: 565–71

Review

Steroid-impregnated dressings and implants appear to be safe, although they likely have increased systemic absorption compared with topical nasal steroid sprays and rinses. There is evidence to support the use of steroid-releasing implants in the ethmoid cavity and frontal sinuses in the postoperative period; however, large trials have not been completed to show significant subjective and objective improvements over surgery alone with meticulous debridement and postoperative care.

A more recent systematic review and meta-analysis is included.

Hoffman V, Mortimer KM, Mulder K et al. (2022) Real-world evidence analysis of the impact of steroid-eluting implants on healthcare resource use among chronic rhinosinusitis patients undergoing sinus surgery. Current Medical Research and Opinion 38: 375–81

Retrospective cohort study

n=3,966 (1,983 SES, 1,983 no implant)

Follow up: 18 months

Use of implants statistically significantly reduced healthcare resource use, including all-cause outpatient visits (94% vs 97%, p<0.001), all-cause otolaryngologist visits (47% vs 60%, p<0.001), and all-cause emergency room or urgent care visits (9% vs 12%, p=0.007), as well as sinus endoscopy (39% vs 44%, p=0.003). Use of implants had no significant effect on sinus procedures such as debridement and polypectomy, as well as sinus-related imaging.

A more recent publication from the same study with longer follow up is included.

Huang Ao, Li T, Li M-S et al. (2023) Association of comorbid asthma and the efficacy of bioabsorbable steroid-eluting sinus stents implanted after endoscopic sinus surgery in patients with chronic rhinosinusitis with nasal polyps. Current Medical Science 43: 1005–12

Post-hoc analysis of randomised controlled trial

n=151

Follow up: 90 days

Asthma was identified as the only risk factor for a poor response to steroid-eluting sinus stents on postoperative day 30, with an OR of 23.7 (95% CI 2.81 to 200.2; p=0.004) for the need for postoperative intervention and 19 (95% CI 2.20 to 164.2; p=0.003) for moderate-to-severe polypoid tissue formation.

Post-hoc analysis of study already included in the key evidence (Huang Z et al., 2022)

Huang Z, Hwang P, Sun Y et al. (2015) Steroid-eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane Database of Systematic Reviews issue 6: CD010436

Systematic review

No studies met inclusion criteria

21 trials had the potential to be included given that they had tested sinus stents, spacers and packing materials for patients with chronic rhinosinusitis undergoing functional ESS. However, the trials were excluded from the review because they met some but not all of the inclusion criteria.

Review did not include any trials.

Hwang CS, Al Sharhan SS, Kim BR et al. (2018) Randomized controlled trial of steroid-soaked absorbable calcium alginate nasal packing following endoscopic sinus surgery. The Laryngoscope 128: 311–16

Randomised controlled trial

n=22 (44 nostrils)

Steroid-soaked, absorbable nasal packing can be used to enhance wound healing after endoscopic sinus surgery and to prevent polypoid changes in the nasal mucosa.

Larger or more recent studies are included.

Study is included in systematic review by Zhang et al. (2021).

Javanbakht M, Saleh H, Hemami MR et al. (2020) A corticosteroid-eluting sinus implant following endoscopic sinus surgery for chronic rhinosinusitis: a UK-based cost-effectiveness analysis.

Pharmaco Economics – Open 4: 679–86

Cost effectiveness model

The use of a SES after ESS results in fewer postoperative complications than non-corticosteroid-eluting implants and may be a cost-saving technology over a 6-month time horizon. Although the cost of initial treatment with the SES is greater, cost savings are made due to a reduction in the number of complications experienced.

Cost effectiveness is not within the remit of Interventional Procedures guidance.

Kennedy DW. (2012) The PROPEL steroid-releasing bioabsorbable implant to improve outcomes of sinus surgery. Expert Review of Respiratory Medicine 5: 493–8

Review

To date, 3 clinical trials have demonstrated that the implant is safe and maintains the results of sinus surgery by decreasing postoperative inflammation, polyposis, adhesions and middle turbinate lateralization. This implant reduces the need for oral corticosteroids with their associated risks and reduces the need for uncomfortable postoperative debridement and removal of scarring.

A more recent systematic review and meta-analysis is included.

Lee VS, Patel P, O'Brien D et al. (2022) Indications for absorbable steroid-eluting sinus implants: Viewpoint via the Delphi method. International Forum of Allergy & Rhinology 12: 1225–31

Delphi study (14 experts answered first survey and 12 answered the second)

Six of a total of 12 statements reached consensus and were accepted. Overall, experts largely agree that intraoperative or in-office use of SES could be considered for people with diabetes or intolerance to oral steroids, those having extended frontal sinus surgery, or with recurrent stenosis.

Delphi study.

Lelegren MJ, Bloch RA, Lam KK (2021) Intraoperative applications of topical corticosteroid therapy for chronic rhinosinusitis. Ear, Nose & Throat Journal 100: 320–28

Review

21 articles

A wide range of techniques and technologies have been introduced to enhance the topical delivery of corticosteroids into the neosinuses after ESS for CRS. Regarding efficacy, there is level 1A evidence to support the use of Propel stents. Most of the remaining strategies show some degree of efficacy. Direct comparisons across the different strategies are limited owing to the varied uses of delivery vectors, corticosteroid choices, and doses of corticosteroids. Propel stents and SinuBand have sufficient data to support systemic and ocular safety, whereas the remaining products have limited data to support their safety.

A more recent systematic review and meta-analysis is included.

Li W, Lu H, Wang H et al. (2020) Efficacy and safety of steroid-impregnated implants following sinus surgery: A meta-analysis. The Laryngoscope 130: 2754–59

Systematic review and meta-analysis

8 randomised controlled trials

Bioabsorbable steroid-impregnated implants following ESS are effective in improving the endoscopic appearance of the healing process, and the safety profile appears to be favourable for the treatment of CRS.

Some study overlap with another systematic review included in the key evidence.

Luong A, Ow RA, Singh A et al. (2018) Safety and effectiveness of a bioabsorbable steroid-releasing implant for the paranasal sinus ostia: A randomized clinical trial. JAMA Otolaryngology - Head and Neck Surgery 144: 28–35

Randomised controlled trial

n=80 (SES versus no implant)

Follow up: 3 months

The SES was safe and more effective in maintaining frontal sinus ostia patency and improving surgical outcomes compared with surgery alone in the setting where no other immediate postoperative corticosteroids were administered.

Included in the meta-analysis by Goshtasbi et al. (2019).

Marple BF, Smith TL, Han JK et al. (2012) Advance II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants. Otolaryngology - Head and Neck Surgery 146: 1004–11

Randomised controlled trial

n=210 sinuses (105 SES, 105 control)

Follow up: 3 months

Compared with control sinuses with non-drug-releasing implants, the drug-releasing implant provided a 29% relative reduction in postoperative interventions (p=0.028) and a 52% (p=0.005) decrease in lysis of adhesions. The relative reduction in frank polyposis was 45% (p=0.002). No clinically significant changes from baseline in intraocular pressure or cataracts were observed.

Included in the meta-analysis by Goshtasbi et al. (2019).

Massey CJ, Suh JD, Tessema B et al. (2016) Biomaterials in Rhinology. Otolaryngology - Head and Neck Surgery 154: 606–17

Review

Steroid delivery systems may play an increasingly important role in reducing disease recurrence after ESS, although more studies are needed to assess long-term outcomes.

A more recent systematic review and meta-analysis is included.

McCormick JP, Suh JD, Yang H-H et al. (2022) Triamcinolone-impregnated bioabsorbable middle meatus packing following endoscopic sinus surgery: A prospective randomized controlled trial. International Forum of Allergy & Rhinology 12: 1131–36

Randomised controlled trial

n=22 (44 sinus cavities)

Follow up: mean 47 days

There was no statistically significant difference in healing between the steroid treated and non-steroid-treated sinuses.

There were no adverse effects identified from the use of steroid-impregnated packing.

Larger studies are included.

Murr AH, Smith TL, Hwang PH et al. (2011) Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. International Forum of Allergy and Rhinology 1: 23–32

Randomised controlled trial

n=76 sinuses (38 SES, 38 control)

Follow up: 2 months

Compared to the control stent, the drug-eluting stent provided statistically significant reduction in inflammation at days 21 to 45 (p<0.003), frequency of polyp formation (p=0.0391), and frequency of significant adhesion (p=0.0313). There were no device-related adverse events.

Included in the meta-analysis by Goshtasbi et al. (2019).

Narwani V, Torabi SJ, Kasle DA et al. (2022) Adverse events associated with corticosteroid-eluting sinus stents: A MAUDE database analysis. Otolaryngology - Head and Neck Surgery 166: 179–82

Retrospective cross-sectional study

28 reported adverse events

The most common adverse event was related to postoperative infection, accounting for 39% (n=11) of all complications. Four of these patients developed periorbital cellulitis, and 5 developed a fungal infection. The second-most common adverse event was migration of the stent, representing 21% of all complications (n=6). Overall, 8 people (29%) in the cohort required reintervention in the operating room, with subsequent removal of the SES.

A similar review of the same database, with a more recent search date is included (Shah et al., 2022).

Orabi NA, Behnke J, Reyes C et al. (2023) Effect of absorbable nasal packing saturated with ciprofloxacin and dexamethasone following endoscopic sinus surgery: A prospective cohort study. International Forum of Allergy & Rhinology 13: 1801–4

Prospective cohort study

n=32

Follow up: 3 months

Chitosan-based absorbable nasal packing saturated with ciprofloxacin-dexamethasone suspension was not associated with any significant differences on postoperative ESS wound healing.

The small sample size was exacerbated by a lack of follow-up endoscopic examinations.

Larger studies are included.

Promentilla S, Onofre R, Campomanes B (2016) Effects of dexamethasone versus saline-impregnated nasal packing on the postoperative outcome of patients with chronic rhinosinusitis and nasal polyps after endoscopic sinus surgery: a randomized controlled trial. Philippine Journal Otolaryngology - Head and Neck Surgery 31: 10–13

Randomised controlled trial

n=19

Follow up: 28 days

Nasal cavities that had postoperative dexamethasone-impregnated nasal packs showed lower POSE scores than placebo on postoperative days 14 (p=0.0022, 95% CI -2.11 to -0.51) as well as lower Lund-Kennedy Scores on postoperative day 14 (p=0.0180, 95% CI -2.49 to -0.26) and day 28 (p=0.007, 95% CI -1.56 to -0.28).

Larger or more recent studies are included.

Rawl JW, McQuitty RA, Khan MH et al. (2020) Comparison of steroid-releasing stents vs nonabsorbable packing as middle meatal spacers. International Forum of Allergy & Rhinology 10: 328–33

Randomised controlled trial

n=40

Follow up: 3 months

Nonabsorbable packing materials showed superior middle meatal spacing capacities as evidenced by greater middle turbinate medialisation capability at the first postoperative visit. There were also improvements in SNOT-22 scores at the 20-day postoperative visit. This study showed that there was no statistically significant improvement in postoperative outcomes with drug-eluting stents when compared to nonabsorbable packing.

Small study, comparing SES with nonabsorbable packing.

Rizan C, Elhassan HA (2016) Post-sinus surgery insertion of steroid-eluting bioabsorbable intranasal devices: A systematic review. The Laryngoscope 126: 86–92

Systematic review

7 studies

Follow up: 2 to 6 months

Steroid-eluting bioabsorbable intranasal devices were effective in reducing adhesion formation, polyp formation, inflammation, Lund-Kennedy scores, and perioperative sinus endoscopy scores. The devices improved patient-reported outcomes and olfaction while reducing postoperative interventions. They were not associated with adverse events and pose no ocular safety risk. Complications were reported in 3 applications (headache, crusting, infection).

A more recent systematic review and meta-analysis is included.

Rizzo JA, Rudmik L, Mallow PJ et al. (2016) Budget impact analysis of bioabsorbable drug-eluting sinus implants following endoscopic sinus surgery. Journal of Medical Economics 19: 829–35

Budget impact model

This study has demonstrated the use of Propel following ESS procedures has a negligible impact on the budget of a US self-insured employer or payer. The upfront cost of Propel was offset by savings associated with reduced probability for polyp recurrence, adhesion formation, and their subsequent treatment.

Budget impact is not within the remit of Interventional procedures guidance.

Rudmik L, Soler ZM, Orlandi RR et al. (2011) Early postoperative care following endoscopic sinus surgery: an evidence-based review with recommendations. International Forum of Allergy and Rhinology 6: 417– 30

Systematic review

3 studies on drug-eluting stents or spacers

An evidence-based postoperative treatment protocol after endoscopic sinus surgery would include the use of nasal saline irrigation, sinus cavity debridement, and initiation of standard topical nasal corticosteroid spray. Due to a relative balance between possible therapeutic advantages and potential adverse effects, the use of postoperative antibiotics, systemic corticosteroids, off-label topical corticosteroid medications, and drug eluting materials are all options for postoperative care.

A more recent systematic review and meta-analysis is included.

Saito T, Okazaki K, Hamada Y et al. (2021) Therapeutic indications for sinonasal topical steroid treatment and its effects on eosinophilic chronic rhinosinusitis after endoscopic sinus surgery. The Journal of Laryngology and Otology 135: 858–63

Retrospective non-randomised comparative study

n=30

(15 SES versus no topical steroid treatment after ESS)

Younger age, higher pre-operative CT score, severe postoperative olfactory loss and worse sinonasal conditions led to the need for sinonasal topical steroid treatment.

Total nasal symptom scores were significantly improved and maintained for 4 weeks during this study.

Small, non-randomised study.

Santarelli GD, Han JK (2016) Evaluation of the PROPEL mini sinus implant for the treatment of frontal sinus disease. Expert Opinion on Drug Delivery 13: 1789–93

Review

Devices such as the Propel and Propel Mini stents are the beginning of a trend towards medication-coated bioabsorbable implants that can be used for sinonasal disease to minimise complications or possible side effects of surgical treatment by an increase of topical drug delivery locally.

A more recent systematic review is included.

Schneider AL, Racette SD, Kang AK et al. (2022) Use of intraoperative frontal sinus mometasone-eluting stents decreased interleukin 5 and interleukin 13 in patients with chronic rhinosinusitis with nasal polyps. International Forum of Allergy & Rhinology 12: 1330–39

Non-randomised comparative study

n=52

Follow up: 8 months

Frontal SES placement may result in longer term changes in middle meatal mucus inflammation.

The changes seen in the study did not correspond to statistically significantly different measures of symptomatic or radiographic disease severity.

Small, non-randomised study.

Shah SJ, Hawn VS, Zhu N et al. (2022) Postoperative infection rate and associated factors following endoscopic sinus surgery. The Annals of Otology, Rhinology, and Laryngology 131: 5–11

Cohort study

n=378 (245 with SES)

Follow up: 30 days

The postoperative infection rate was 10%. Multivariate logistic regression analysis showed that postoperative systemic corticosteroid use was the only risk factor independently associated with infection (OR 3.47, 95% CI 1.23 to 9.76, p=0.018).

There was no correlation between postoperative infection and presence of a SES.

More comprehensive studies are included.

Shen J, Welch K, Kern R (2018) Mometasone furoate sinus implant-a new targeted approach to treating recurrent nasal polyp disease. Expert Review of Clinical Pharmacology 11: 1163–70

Review

Clinical evidence has demonstrated the safety and efficacy of steroid-eluting implant in the reduction of polyp size, symptom burden, and the need for revision sinus surgery.

A more recent systematic review is included.

Singh A, Luong AU, Fong KJ et al. (2019) Bioabsorbable steroid-releasing implants in the frontal sinus ostia: a pooled analysis. International Forum of Allergy and Rhinology 9: 131–139

Pooled analysis of 2 randomised controlled trials

n=160 (SES versus no implant)

Follow up: 3 months

Bioabsorbable steroid-releasing sinus implants improve outcomes of frontal sinus surgery through 90 days, irrespective of asthma status, previous endoscopic sinus surgery, extent of surgery, extent of polyps, or Lund-Mackay computed tomography stage in the frontal sinus ostia.

Included in the meta-analysis by Goshtasbi et al. (2019).

Smith KA, Kingdom TT, Gray ST et al. (2020) Drug-eluting implants in chronic rhinosinusitis: an evidence-based review with recommendations. International Forum of Allergy & Rhinology 10: 856–70

Systematic review

31 studies

Absorbable steroid-eluting implants are recommended for carefully selected patients with CRS. Additional research to define appropriate patient selection is needed.

No meta-analysis. There is a lot of overlap with the studies included in Goshtasbi et al. (2019).

Smith TL, Singh A, Luong A, et al. (2016) Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 126: 2659–2664

Randomised controlled trial

n=80 (SES versus no implant)

Follow up: 3 months

SES provided a statistically significant reduction in the need for postoperative interventions compared to surgery alone at 30 and 90 days. There was a 56% reduction in the need for oral steroid (p=0.0015), 75% reduction in the need for surgical interventions (p=0.0225), 17% reduction in inflammation score, 54% reduction in restenosis rate (p=0.0002), and 32% greater diameter of frontal sinus ostia (p<0.0001). No implant-related adverse events were reported.

Included in the meta-analysis by Goshtasbi et al. (2019).

Sow YL, Tang IP, Kho J et al. (2018) Pilot study comparing steroid-impregnated and non-steroid-impregnated absorbable nasal dressing following endoscopic sinus surgery. Medical Journal of Malaysia 73: 244–48

Randomised controlled trial

n=8 (bilateral ESS)

Follow up: 3 months

Gelfoam can be used as nasal packing material to deliver topical steroid after endoscopic sinus surgery. Steroid-impregnated nasal dressing after endoscopic sinus surgery may not provide better long-term outcome.

Studies with more people or longer follow up are included.

Taweewuthisub O, Chusakul S, Kanjanaumporn J et al. (2021) Is add-on budesonide-impregnated nasal dressing useful following endoscopic sinus surgery with perioperative oral steroid? Journal of the Medical Association of Thailand 104: 293–99

Randomised controlled trial

n=18 (bilateral ESS)

Follow up: 4 weeks

Budesonide-impregnated polyurethane foam did not provide additional benefits on mucosal inflammation and wound healing in the patients who underwent ESS and received a short course of oral steroid perioperatively.

Studies with more people or longer follow up are included.

Weber CM, Schmidtmayer U, Stolle SRO et al. (2019) The novel Propel mini stent - Indications, surgical technique and first clinical experience. Laryngo- Rhino- Otologie 98: 408–12

Prospective case series

n=21

Follow up: 6 months

There were no complications and complete stent degradation. The follow-up examinations showed satisfactory results over 6 months.

Studies with more people or longer follow up are included.

Wu AW, Sharma D, Illing EA et al. (2023) Ostial patency measurements after endoscopic sphenoidotomies and frontal sinusotomies. The Annals of Otology, Rhinology, and Laryngology 132: 1584–89

Prospective cohort study

n=50

(78 sphenoid sinuses and 71 frontal sinuses with 39 SES)

Follow up: 6 months

Both the sphenoid and frontal sinus ostia had a significant decrease in size over the initial postoperative period of 3 months by 42% and 40%, respectively; however, there was no significant change in ostial size from 3 to 6 months postoperatively.

The ostial patency of the frontal sinus can be improved with the use of SES, particularly in patients with history of prior sinus surgery.

Small cohort study focusing on the patency of the sphenoid and frontal sinus ostia after FESS.

Xu JJ, Busato G-M, McKnight C et al. (2016) Absorbable steroid-impregnated spacer after endoscopic sinus surgery to reduce synechiae formation. The Annals of Otology, Rhinology, and Laryngology 125: 195–8

Retrospective cohort study

n=146

Follow up: 1 month

Synechiae formed in 2% of cavities with an absorbable spacer and 6% of cavities with a non-absorbable spacer, but this difference was not statistically significant (OR=0.34, p=0.052).

More recent studies with more people or longer follow up are included.

Xu J, Park SJ, Park HS et al. (2016) Effects of triamcinolone-impregnated nasal dressing on subjective and objective outcomes following endoscopic sinus surgery. European Archives of Oto-rhino-laryngology 273: 4351–57

Randomised controlled trial

n=58 (28 steroid-soaked and 30 saline-soaked dressing)

Follow up: 3 months

Steroid-impregnated biodegradable nasal dressing was not related to the improvement of subjective symptoms compared to saline- soaked dressing. However, it had a statistically significant advantage regarding postoperative wound healing and improvement of olfactory function during the short follow-up.

Small trial, which is included in the systematic by Zhang et al. (2021).

Zhao X, Grewal A, Briel M et al. (2013) A systematic review of nonabsorbable, absorbable, and steroid-impregnated spacers following endoscopic sinus surgery. International Forum of Allergy and Rhinology 3: 896–904

Systematic review

11 RCTs (5 steroid versus plain spacer; 6 nonabsorbable versus absorbable)

Comparison between nonabsorbable spacers and absorbable spacers showed that there was no significant difference in adhesion rates if nonabsorbable spacers are used for at least 48 hours after surgery. Corticosteroid spacers may reduce adhesions, but more consistent data reporting is required for meta-analysis.

A more recent systematic review and meta-analysis is included.

Zhao K-Q, Yu Y-Q, Yu H-M (2018) Effects of mometasone furoate-impregnated biodegradable nasal dressing on endoscopic appearance in healing process following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study. International Forum of Allergy and Rhinology 8: 1233–41

Randomised controlled trial

n=64

Follow up: 3 months

Mometasone furoate-impregnated biodegradable nasal dressings improve the endoscopic appearance in the healing process of CRS with nasal polyposis after ESS.

Small trial, which is included in the systematic by Zhang et al. (2021).

Zheng L, Chen Z, Jin J et al. (2023) The efficacy of steroid-eluting stents on the local inflammation of chronic rhinosinusitis with nasal polyposis after endoscopic sinus surgery: a multicenter prospective longitudinal study. European Archives of Oto-rhino-laryngology 280: 5417–31

Prospective cohort study

n=57 (30 with SES, 27 without)

Follow up: 12 weeks

Nasal obstruction, nasal discharge, loss of smell, and total VAS scores decreased at 12 weeks postoperatively compared to preoperatively (p<0.01) and POSE score outcomes were also lower at 8 and 12 weeks postoperatively compared to 2 weeks postoperatively (p<0.05). SES played a crucial role in ameliorating postoperative local inflammation levels, accelerating wound recovery, and promoting epithelialisation in CRS with nasal polyposis. Larger trials with longer duration are needed to validate the effect of SES on the local inflammation after ESS.

Studies with more people or longer follow up are included.