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Fibrin Glue vs. Suture in Pterygium Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01158014
First received: July 4, 2010
Last updated: July 8, 2010
Last verified: July 2010
History of Changes
  Purpose

The use of Fibrin glue to place conjunctival graft will be as effective as suturing the graft, but will require much less operative time and will be better tolerated by the patients.


Condition Intervention
Conjunctival Autograft
 Procedure: Fibrin Glue, Quixil
Procedure: Suture

Study Type: Interventional
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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Procedure: Suture
vicryl 10/0

Detailed Description:

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$) suffice for 10 cases, while one vicryl suture costs around 34 US$.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary pterygium
  • healthy subject
  • ability to attend follow-up visits

Exclusion Criteria:

  • recurrent pterygium
  • underwent previous surgery / intervention to treat pterygium
  • ocular surface disease 0 minor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158014

Contacts
Contact: Guy J Ben Simon, MD 972509716632 guybensimon@gmail.com
Contact: Mordechai Rosner, MD 972526667242 Mordecai.Rosner@sheba.health.gov.il

Locations
Israel
Sheba_Medical_Center Recruiting
Ramat Gan, Israel, 52621
Contact: Guy J Ben Simon, MD     97235302874     guybensimon@gmail.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            
Sponsors and Collaborators
Sheba Medical Center
  More Information

Publications:

Responsible Party: Guy J. Ben Simon, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01158014     History of Changes
Other Study ID Numbers: SHEBA-09-5033-GB-CTIL
Study First Received: July 4, 2010
Last Updated: July 8, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
pterygium
conjunctival graft
recurrence
primary pterygium

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Fibrin Tissue Adhesive
Hemostatics
 Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013