Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.

NCT ID: NCT04733846

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-18

Study Completion Date

2021-12-05

Brief Summary

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Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic.

This has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. The aim of this study is to evaluate the Vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic Nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.

Detailed Description

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Conditions

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Eye Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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corneal trauma sutured with Vicryl 10-0 monofilament

corneal trauma sutured with Vicryl 10-0 monofilament will be included. They will have data collection of medical records.

data collection

Intervention Type OTHER

Collection of clinical and paraclinical data during preoperative consultation Collection of clinical and paraclinical data during post-operative consultations Tele-consultation to determine if criteria for good healing / adherence, treatment tolerance / response to questions Remote follow-up 6 and 12 months after the trauma

Interventions

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data collection

Collection of clinical and paraclinical data during preoperative consultation Collection of clinical and paraclinical data during post-operative consultations Tele-consultation to determine if criteria for good healing / adherence, treatment tolerance / response to questions Remote follow-up 6 and 12 months after the trauma

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Corneal penetrating injury and/or lamellar laceration

Exclusion Criteria

* Corneal Penetrating injury trauma requiring necessarily ONLY Nylon 10-0
* Traumatism requiring necessarily a cryopreserved human amniotic membrane (for example)
* Traumatism eligible for biological glue (long-axis wound \< 2 mm)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thibaut GARCIN, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN202021/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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