NCT03321201

Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: University of Split, School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pterygium is a noncancerous growth of the conjunctival tissue over the cornea. It is a progressive disease that may lead to visual impairment in advanced stages, as well as restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. In this randomized controlled cauterization will be compared with fibrin glue for conjunctival autografting in primary pterygium surgery.

Conditions

• Pterygium of Conjunctiva and Cornea

Interventions

Type	Name	Description
PROCEDURE	Cauterization	To ensure the stability of the graft during cuttings, four sealing wraps will be installed, which will be removed after cauterisation is completed. Autograft and conjunctiva will be approximated by surgical forceps and will be cauterized using a bipolar cutter (Erbe ICC 50) with a force 1-3 / 20. Forceps will be released slowly to prevent elevation of the graft. The same procedure will be performed 10 times until graft is well firmed. Graft stability will be checked up with a sponge and additional cauterization will be preformed if needed.
PROCEDURE	Fibrin glue	Fiber adhesive (Tissel 1 mL kit4-iu) will be prepared according to manufacturer's instructions. Preparation time will be approximately 10-15 min per kit. Once mixed the fibrin glue is usable up to 4 h. For the purpose of the study preparation of the fibrin glue will be performed by a nurse.

Timeline

• Start date: 2018-05-08
• Primary completion: 2025-05-01
• Completion: 2026-12-31
• First posted: 2017-10-25
• Last updated: 2022-11-02

Locations

1 site across 1 country: Croatia