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Fibrin Sealant in Eyelid Surgery

NCT05358977 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-03

No results posted yet for this study

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 Unpublished work suggests that it is effective in decreasing postoperative bruising.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

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Karim Punja, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-05-31
Completion
2023-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05358977 on ClinicalTrials.gov