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

NCT04733846 | Completed

• 1 other identifier: IRBN202021/CHUSTE
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eye Trauma

Keywords

Corneal; penetrating injury; lamellar laceration; COVID; polyglactin; Vicryl

Outcome Measures

Primary Outcomes (2)

• change visual acuity (Snellen scale) from baseline and 2, 6, 12 and 18 months after the intervention

  Collected in the medical record.

  Months: 0, 2, 6, 12, 18

• change Visual acuity (Parinaud scale) from baseline and 2, 6, 12 and 18 months after the intervention

  Collected in the medical record.

  Months: 0, 2, 6, 12, 18

Secondary Outcomes (3)

• Astigmatism (diopter)

  Months: 0, 2, 6, 12, 18

• Number of postoperative external consultations

  Months: 0, 2, 6, 12, 18

• Adverse events

  Months: 0, 2, 6, 12, 18

Study Arms (1)

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.

Other: data collection

Interventions

data collection 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

corneal trauma sutured with Vicryl 10-0 monofilament

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had an emergency eye surgery in the Saint-Etienne University Hospital from 18/03/2020 to 05/12/2020

You may qualify if:

• Corneal penetrating injury and/or lamellar laceration

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Eye Injuries; Wounds, Penetrating

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Eye Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Thibaut GARCIN, MD PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 2, 2021
• Study Start: March 18, 2020
• Primary Completion: December 5, 2020
• Study Completion: December 5, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)