Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2022-05-31
2023-06-30
Brief Summary
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Detailed Description
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Postoperatively, patients will take photographs on postoperative days 1, 3, 7. Photographs with poor quality not allowing accurate assessment will not be scored and that visit will not be included in the study. The photographs will be assessed by two masked ophthalmic surgeons who will rate the degree of postoperative bruising. Upper and lower eyelids of each patient will be evaluated separately. Observers will assess each side for ecchymosis using a 10-point Likert scale (1, none; 10, severe) on postoperative days 1, 3 and 7.
Given a blepharoplasty costs the healthcare system approximately $950 Canadian dollars, a vial of Tisseel ($160) would add approximately 17% to the cost (160/942.43 = 16.97%). Therefore, a 17% percent margin of superiority was used in power calculations to determine statistical efficacy of the intervention.
A power calculation for a randomized control superiority trial was performed. A 17% percent margin of superiority was used in power calculations. These variable were used to calculate for a dichotomous outcome superiority trial. The calculated sample size was calculated to be 27 in each group.
Tisseel is made from human plasma and may therefore contain infectious agents, such as viruses, that can cause disease. With over two decades of use, there has never been a reported case of hepatitis (HAV, HBV, HCV) or human immunodeficiency virus (HIV) transmission. However, Tisseel used during thoracic surgery has been associated with increased seropositivity for parvovirus B19. Although there were no complications associations with the parvovirus B19 infection observed, infection with parvo B19 can theoretically cause anemia or arthralgias, fifth disease in children, miscarriage, or rash. All patients who would be at risk of complications from such an infection were excluded.
Research is ongoing, despite the continuation of the COVID-19 pandemic. Postoperative photographs taken by the patients are used to minimize contact during care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Tisseel
Patients are undergoing bilateral blepharoplasty. In this arm (Tisseel), the patient with undergo blepharoplasty with topical Tisseel placed in the incision prior to standard closure. 1 minute of pressure will be exerted to both eyelids after closure to mask the patient as to which eyelid received the Tisseel.
Tisseel
Intraoperatively, the intervention side will receive topical administration of Tisseel to the blepharoplasty incision. A 2mL syringe of Tisseel product will be used as per the product monograph for an area of \< 8cm2. There will be no variation in surgical counselling or technique, with the exception of the use of Tisseel in one eyelid closure. Both eyelids will otherwise receive standard blepharoplasty surgical techniques. There will be no monitoring of compliance necessary, given the Tisseel will be utilized intraoperatively.
Control
Patients are undergoing bilateral blepharoplasty. In this arm (Control), the patient with undergo blepharoplasty with standard closure along. 1 minute of pressure will be exerted to both eyelids after closure to mask the patient as to which eyelid received the Tisseel.
No interventions assigned to this group
Interventions
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Tisseel
Intraoperatively, the intervention side will receive topical administration of Tisseel to the blepharoplasty incision. A 2mL syringe of Tisseel product will be used as per the product monograph for an area of \< 8cm2. There will be no variation in surgical counselling or technique, with the exception of the use of Tisseel in one eyelid closure. Both eyelids will otherwise receive standard blepharoplasty surgical techniques. There will be no monitoring of compliance necessary, given the Tisseel will be utilized intraoperatively.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Religious belief prohibiting the use of blood products
* Pregnancy
* Immunodeficiency
* Age ≤18 years of age
* Breastfeeding women
19 Years
ALL
Yes
Sponsors
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University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Karim Punja, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Central Contacts
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References
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Thompson DF, Letassy NA, Thompson GD. Fibrin glue: a review of its preparation, efficacy, and adverse effects as a topical hemostat. Drug Intell Clin Pharm. 1988 Dec;22(12):946-52. doi: 10.1177/106002808802201203.
Sowerby L, Kim LM, Chow W, Moore C. Intra-operative nasal compression after lateral osteotomy to minimize post-operative Peri-orbital ecchymosis and edema. J Otolaryngol Head Neck Surg. 2019 Oct 16;48(1):50. doi: 10.1186/s40463-019-0370-7.
Zoumalan R, Rizk SS. Hematoma rates in drainless deep-plane face-lift surgery with and without the use of fibrin glue. Arch Facial Plast Surg. 2008 Mar-Apr;10(2):103-7. doi: 10.1001/archfaci.10.2.103.
Marchac D, Greensmith AL. Early postoperative efficacy of fibrin glue in face lifts: a prospective randomized trial. Plast Reconstr Surg. 2005 Mar;115(3):911-6; discussion 917-8. doi: 10.1097/01.prs.0000153219.32665.d5.
Panda A, Kumar S, Kumar A, Bansal R, Bhartiya S. Fibrin glue in ophthalmology. Indian J Ophthalmol. 2009 Sep-Oct;57(5):371-9. doi: 10.4103/0301-4738.55079.
Horowitz B, Busch M. Estimating the pathogen safety of manufactured human plasma products: application to fibrin sealants and to thrombin. Transfusion. 2008 Aug;48(8):1739-53. doi: 10.1111/j.1537-2995.2008.01717.x. Epub 2008 May 7.
Kawamura M, Sawafuji M, Watanabe M, Horinouchi H, Kobayashi K. Frequency of transmission of human parvovirus B19 infection by fibrin sealant used during thoracic surgery. Ann Thorac Surg. 2002 Apr;73(4):1098-100. doi: 10.1016/s0003-4975(02)03415-x.
Other Identifiers
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REB21-0341
Identifier Type: -
Identifier Source: org_study_id
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