Clinical case series describes a contraindication for SerenoCem Granules™ in mastoid obliteration: Our experience in sixty‐four patients

Harrison, Laura; Kumar, Santosh; Bull, Matthew; Hatton, Paul V.; Bottrill, Ian; Aldren, C.

doi:10.1111/coa.12886

Cited by 8 publications

(18 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…• With MHRA guidance, the granules were removed from the market and clinical advice was issued regarding the appropriate management and follow-up of these patients • Interval CT scanning after 2 years has now shown that there is no evidence of progression in bone resorption when the granules are left in situ F I G U R E 1 A flowchart summarising the outcomes of the 55 implanted patients | 1155 CORRESPONDENCE: OUR EXPERIENCE progression on interval scans in this study supports the authors'initial theory that the bone erosion occurs early after implantation. It is postulated that the erosive effect seen after implantation of the granules is due to a local inflammatory process, in keeping with histological analysis reported in the initial study 1.…”

supporting

confidence: 81%

“…Although Serenocem granules were withdrawn from market in 2016 due to the findings of our group in the prequel to this study, we felt it was important to evaluate for any progression in bone erosion to guide clinical follow‐up in the over 1000 patients implanted with the material during its use in mastoid obliteration surgery. The authors suggest that patients previously implanted with SerneoCem™ granules who are asymptomatic do not require any additional further intervention or monitoring.…”

Section: Discussionmentioning

confidence: 99%

“…SerenoCem™ granules (Corinthian Medical Ltd) are a pre‐set version of SerenoCem™ ionomeric cement, which is a bone‐bonding and bioactive material marketed since 1999, and have been used in mastoid obliteration surgery. Our previous work had revealed a propensity for the granules to cause resorption of bone adjacent to the site of implantation, leading to the Medicines and Healthcare products Regulatory Agency (MHRA) issuing an instruction to terminate the use of these granules . The manufacturer voluntarily removed them from the market.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

SerenoCem™ granules in mastoid obliteration surgery: A 2‐year follow‐up case series of 55 patients to determine the risk of progressive bone resorption

Cherko

Harrison

Chawdhary

et al. 2019

Clinical Otolaryngology

Self Cite

View full text Add to dashboard Cite

supporting

confidence: 81%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

SerenoCem™ granules in mastoid obliteration surgery: A 2‐year follow‐up case series of 55 patients to determine the risk of progressive bone resorption

Cherko

Harrison

Chawdhary

et al. 2019

Clinical Otolaryngology

Self Cite

View full text Add to dashboard Cite

“…[1][2][3][4][5] Mastoid reconstruction principle had been described to overcome these problems and different materials were used; these materials can be classified into: (1) free grafts (biologic and nonbiologic) and (2) local flaps. [4][5][6][7][8][9][10] All of these techniques have their advantages and disadvantages but nonbiologic materials seem to be less preferred. 1,2,6 Platelet-rich plasma (PRP) is a simple laboratory method to obtain a high concentrates of autologous growth factors.…”

Section: Introductionmentioning

confidence: 99%

“…Unfortunately, such a perfect solution is yet to show up. [1][2][3][4][5][6] The chosen surgical procedure should be tailored to the patient's condition, size of mastoid cavity, and surgeon's experience. 1,2,4 Materials for Mastoid Reconstruction Different materials were used; they can be classified into 2 main categories: (1) free grafts (biologic and nonbiologic) and (2) local flaps.…”

Section: Introductionmentioning

confidence: 99%

Mastoid Reconstruction With Platelet-Rich Plasma and Bone Pate After Canal Wall Down Mastoidectomy: A Preliminary Report

2019

View full text Add to dashboard Cite

Objectives: Mastoid reconstruction principle had been described to overcome problems of chronic discharging cavity. Different materials were used; nonbiologic materials seem to be less preferred. Platelet-rich plasma (PRP) could promote the regeneration of mineralized tissues. In this work, the authors present a simple and easy technique for mastoid reconstruction with PRP and cortical bone pate. Methods: The study design is a case series. Patients had mastoid reconstruction after canal wall down mastoidectomy using PRP and cortical bone pate. Results: This study included 21 patients: 9 males, and 12 females. Sixteen patients had left side disease. All surgical procedures were conducted smoothly within 90 to 135 minutes with no stressful events had been reported. At 12 to 16 months of follow-up, external canal stenosis and mastoid fistulas were not reported. Good healing of the tympanic membrane was seen in 18 patients. No radiological signs suggestive of recurrence were detected and the reconstructed mastoid cavity was smooth and well aerated. Residual tympanic membrane perforations were detected in 3 patients. Conclusion: Autologous materials (PRP and bone pate pate) after canal wall down mastoidectomy appear to be a reliable and effective choice for mastoid reconstruction.

show abstract

Antibiotics in mastoid and epitympanic obliteration withS53P4bioactive glass: A retrospective study

Alciato¹,

Bernardeschi²,

Pourcher

et al. 2022

Laryngoscope Investig Oto

View full text Add to dashboard Cite

Objective The role of antibiotics in ear surgery is still controversial. The aim of this study was to assess their need in cholesteatoma surgery when performing obliteration with S53P4 bioactive glass, a biocompatible material with antibacterial properties. Methods This retrospective cohort study was conducted in a tertiary referral center between January 2017 and May 2019. Sixty‐nine consecutive patients, who underwent surgery for cholesteatoma removal and/or rehabilitation of canal‐wall‐down mastoidectomy with mastoid and epitympanic obliteration using S53P4 granules were included. Before 2019, antibiotics were routinely used (group “w/AB”). Patients received intravenous antibiotics during surgery, oral treatment was continued for 7 days and topical antibiotics for 1 month. After 2019, no antibiotics were administered (group “w/oAB”). The primary outcome was the occurrence of early surgical site infection. Secondary outcomes were late infection, anatomic and functional results at 3 and 12 months. Results Twenty‐three patients were included in group “w/oAB” and 46 in group “w/AB”, with no significant differences in demographics, medical history or follow‐up. Five ears (22%) in group “w/oAB” developed an early infection compared with 2 (4%) in group “w/AB” ( p = .03). The relative risk was 6.11, 95CI%[1.09;31.96]. Infections were successfully treated with antibiotics, and no patient underwent surgical removal of the granules. No late infections or complications were observed. There was no difference in graft failure or air‐bone gap closure at 1 year. Conclusion Peri‐/post‐operative antibiotics prevent early infection in obliteration surgery with S53P4 granules. Infections can be treated medically without complications or require removal of the implanted material. Level of evidence 4.

show abstract

Clinical case series describes a contraindication for SerenoCem Granules™ in mastoid obliteration: Our experience in sixty‐four patients

Abstract: Article type : Our Experience Clinical case series describes a contraindication for SerenoCem Granules TM in mastoid obliteration: Our experience in sixty-four patients.

Cited by 8 publications

References 8 publications

SerenoCem™ granules in mastoid obliteration surgery: A 2‐year follow‐up case series of 55 patients to determine the risk of progressive bone resorption

SerenoCem™ granules in mastoid obliteration surgery: A 2‐year follow‐up case series of 55 patients to determine the risk of progressive bone resorption

Mastoid Reconstruction With Platelet-Rich Plasma and Bone Pate After Canal Wall Down Mastoidectomy: A Preliminary Report

Antibiotics in mastoid and epitympanic obliteration withS53P4bioactive glass: A retrospective study

Contact Info

Product

Resources

About