Fibrin Glue vs. Suture in Pterygium Surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Fibrin Glue vs. Vicryl Suture in Pterygium Surgery With Conjunctival Auto-graft|
- Pterygium recurrence [ Time Frame: one year ] [ Designated as safety issue: No ]Recurrence normally occurs 1-6 months after surgery. Success is achieved if ptergium does not recur after one year.
- operation time [ Time Frame: one year ] [ Designated as safety issue: No ]suturing a conjunctival graft takes 15-10 minutes while gluing only 5 minutes, we believe that by lowering OR time, total costs of surgery are less
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Fibrin Glue, surgery
Conjunctival autograft will be glued using fibrin glue to pterygia bed after removal
Procedure: Fibrin Glue, Quixil
quixil 0.1 ml
Active Comparator: Control
Conjunctival autograft will be sutured using 10/0 vicryl sutures to pterygia bed after removal
Pterygium surgery requires removal of the pterygia from cornea and conjunctiva and an additional technique to prevent recurrence which may be as high as 50%.
Suturing a conjunctival auto-graft has become one of the most popular and effective methods in preventing recurrence. However suturing requires long operative time (10-20 minutes with removal alone less than 5 minutes) and requires sutures removal after 1-2 weeks which is very inconvenient to the patient.
Using Fibrin Glue (Quixil) has been used in several places in pterygium surgery and we believe it will be as effective as suturing the graft, will use much less OR time (reduce surgery time from 40 minutes to 20-25 minutes) and will be less expensive since 2 ml glue (around 80US$) suffice for 10 cases, while one vicryl suture costs around 34 US$.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158014
|Contact: Guy J Ben Simon, MDfirstname.lastname@example.org|
|Contact: Mordechai Rosner, MD||972526667242||Mordecai.Rosner@sheba.health.gov.il|
|Ramat Gan, Israel, 52621|
|Contact: Guy J Ben Simon, MD 97235302874 email@example.com|
|Contact: Mordechai Rosner, MD 972526667242 Mordecai.Rosner@sheba.health.gov.il|
|Principal Investigator: Guy J Ben Simon, MD|
|Sub-Investigator: Mordechai Rosner, MD|
|Sub-Investigator: Nachum Rosen, MD|