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Efficacy of Autologous Fibrin Glue in Pterygium

NCT04151017 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-03-14

No results posted yet for this study

Summary

Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Commercially available fibrin glue has been used preferentially for graft fixation due to its benefits compared to sutures; However, its cost and the risk of inflammatory immune reaction limit the its use. There are few studies about autologous fibrin glue.

OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients undergoing pterygium resection surgery. To compare with autologous conjunctival graft fixation with suture.

This is a randomized clinical trial. Two patient groups will undergo pterygium excision surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue and group 2 will have suture graft fixation using 10.0 mononylon. Early and late postoperative surgical results as well as complication rates will be analyzed.

Conditions

  • Pterygium

Interventions

OTHER

Autologous fibrin glue

Conjunctival graft fixation with autologous fibrin glue

OTHER

Suture

Graft fixation using 10.0 mononylon

Sponsors & Collaborators

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    collaborator OTHER

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Diane Marinho · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-12
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • Brazil

Study Locations

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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 NCT04151017 on ClinicalTrials.gov