Fibrin Sealant in Eyelid Surgery

NCT05358977 | Unknown Phase 2 FDA Drug

• 1 other identifier: REB21-0341
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 Unpublished work suggests that it is effective in decreasing postoperative bruising.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.

Conditions

Blepharoptosis; Ecchymosis; Eyelid

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Study Arms (2)

Tisseel

EXPERIMENTAL

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.

Biological: Tisseel

Control

NO INTERVENTION

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.

Interventions

Tisseel BIOLOGICAL

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.

Tisseel

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing bilateral upper eyelid blepharoplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Related Publications (7)

• 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.

  PMID: 2468466 BACKGROUND

• 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.

  PMID: 31619274 BACKGROUND

• 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.

  PMID: 18347237 BACKGROUND

• 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.

  PMID: 15731694 BACKGROUND

• 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.

  PMID: 19700876 BACKGROUND

• 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.

  PMID: 18466171 BACKGROUND

• 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.

  PMID: 11996248 BACKGROUND

MeSH Terms

Conditions

Blepharoptosis; Ecchymosis

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Karim Punja, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Plemel, MD

CONTACT

(403) 255-5561; dplemel@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 3, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share