search
Back to results

Fibrin Sealant in Eyelid Surgery

Primary Purpose

Blepharoptosis, Ecchymosis; Eyelid

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tisseel
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blepharoptosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Patient undergoing bilateral upper eyelid blepharoplasty

Exclusion Criteria:

  • Hypersensitivity to the fibrin adhesive or components of it
  • Religious belief prohibiting the use of blood products
  • Pregnancy
  • Immunodeficiency
  • Age ≤18 years of age
  • Breastfeeding women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Tisseel

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Bruising as defined by masked observers using a 10-point Likert scale.
    Postoperative 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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 19, 2022
    Last Updated
    May 2, 2022
    Sponsor
    University of Calgary
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05358977
    Brief Title
    Fibrin Sealant in Eyelid Surgery
    Official Title
    Fibrin Sealant to Reduce Postoperative Bleeding After Blepharoplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Calgary

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is looking at the effect of Tisseel in eyelid surgery. Fibrin sealants (Tisseel) cause there to be less bleeding during surgery. Surgeons have used Tisseel for over two decades to reduce bruising. Ophthalmologists use it during surgery. Yet, there are no studies confirming the effect of Tisseel during eyelid surgery. Unpublished work suggests that it is effective in decreasing postoperative bruising. This study will confirm the effect of Tisseel on postoperative bruising in blepharoplasty.
    Detailed Description
    The study is designed as a superiority randomized control trial. Tisseel will be used for hemostasis during the closure of one blepharoplasty incision. The side to receive Tisseel will be determined using a random number generator. After application of topical Tisseel, both eyelids will undergo standard blepharoplasty closure techniques. Pressure will be placed on both upper eyelids to mask the patient as to what side received the Tisseel. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blepharoptosis, Ecchymosis; Eyelid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Each participant in the study will receive a topical application of fibrin sealant (Tisseel) in one of their upper eyelid eyelid blepharoplasty closures in addition to standard blepharoplasty closure techniques. The other eyelid will receive standard blepharoplasty closure techniques alone, without fibrin sealant. Both sides will receive 1 minute of pressure, after application of Tisseel, to mask which side received treatment.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    At the end of the intervention, both sides will receive 1 minute of pressure to mask the patient as to which side received treatment. Postoperative 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.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tisseel
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Tisseel
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Bruising as defined by masked observers using a 10-point Likert scale.
    Description
    Postoperative 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.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Patient undergoing bilateral upper eyelid blepharoplasty Exclusion Criteria: Hypersensitivity to the fibrin adhesive or components of it Religious belief prohibiting the use of blood products Pregnancy Immunodeficiency Age ≤18 years of age Breastfeeding women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Plemel, MD
    Phone
    (403) 255-5561
    Email
    dplemel@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karim Punja, MD
    Organizational Affiliation
    University of Calgary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    2468466
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31619274
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18347237
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15731694
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19700876
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18466171
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11996248
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Fibrin Sealant in Eyelid Surgery

    We'll reach out to this number within 24 hrs