Fibrin Sealant in Eyelid Surgery

Phase 2

• Conditions: Ecchymosis; Eyelid; Blepharoptosis
• Interventions: Biological: Tisseel

• Registration Number: NCT05358977
• Lead Sponsor: University of Calgary

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 Unpublished work suggests that it is effective in decreasing postoperative bruising.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

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-19
• Study Start: 2022-05
• Study First Submitted QC: 2022-05-02
• Last Update Submitted: 2022-05-02
• Study First Posted: 2022-05-03
• Last Update Posted: 2022-05-03
• Primary Completion: 2023-05
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tisseel	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.

Primary Outcome Measures

Name	Time	Method
Bruising as defined by masked observers using a 10-point Likert scale.	1 week	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.