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A prospective consecutive study of demineralized bone matrix and fibrin glue sandwich method to orbital bone reconstruction with absorbable mesh

A prospective consecutive study of demineralized bone matrix and fibrin glue sandwich method to orbital bone reconstruction with absorbable mesh

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0001557
Enrollment
20
Registered
2015-07-06
Start date
2015-04-20
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : A total of 20 patients who are getting surgery with absorbable mesh are involved in the study and separated into two groups, comprised of 10 patients each. DBM(1cc) is applied in one group, and

Sponsors

Hallym University Medical Center-Kangnam
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have following conditions are included in the study: bone defect less than 2cm2, age over 18, at least partially intact visual fields in both eyes prior to the orbital floor fracture, less than 2 weeks after trauma date, confirmed schedule for surgery, and written consent for participating in the study. In case of eyeball injury, confirmation of availability of the surgery from at least one ophthalmologist is needed.

Exclusion criteria

Exclusion criteria: Patients who have at least one of the following conditions are excluded from the study: both orbital floor fracture, prior fracture in the candidate site for surgery, orbital roof fracture, eyeball injury(without confirmation of availability of the surgery from at least one ophthalmologist), visual defect due to neurologic disorder, malignant neoplasm, alcohol or drug abuse, under enforcement of law, short life expectancy due to severe medical condition, disability to read consent form(e.g. illiterate or foreigner), or expected difficulty under decision of principal investigator.

Design outcomes

Primary

MeasureTime frame
Allergic reaction due to application of DBM

Secondary

MeasureTime frame
Other side effects due to application of DBM

Countries

Korea, Republic of

Contacts

Public ContactJooHyun Kim

Hallym University Medical Center-Kangnam

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026