Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold

Air Force Military Medical University of People's Liberation Army

Status

Unknown

Conditions

Peripheral Nerve Injuries

Treatments

Device: nerve scaffold

Study type

Interventional

Funder types

Other

Identifiers

NCT03780855

KY20172005-1

Details and patient eligibility

About

The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels. 10 patients with peripheral sensory nerve defects will be involved and divided into 2 groups: the experimental group is treated with the nerve scaffold, and the control group without that. Then follow the cases up and draw conclusion according to the results of observation and examination.

Full description

The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels developed in the Department of Orthopaedics in Xijing hospital in repairing the peripheral nerve defect. According to the inclusion and exclusion criteria, 10 patients with peripheral sensory nerve defects of 1 to 3 cm in size will be involved. Divided them into 2 groups. The experimental group of 5 cases will be treated with the nerve scaffold, and the control group without that. Then follow the cases up at about 2 weeks, 3 months and 6 months after surgery. Observe the condition of the healing of the local wound and the whole body of the 10 patients. Examine the blood routine and biochemical indexes of the experimental group. Sensory recovery of injured nerves will be tested at about 3 months and 6 months after surgery. Record the results in the case report forms. Analyze the data statistically and draw conclusion.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age from 18-50 yeas old, male or female, course of disease is within one year;
good heart, liver and kidney function;
with peripheral sensory nerve defects of 1-3 cm in size, and willing to repair it with the nerve scaffold;
no significant damage existing in the skin and soft tissue in the operative region
have signed the informed consent form
good adherence and willing to return for follow-up visits as required.

Exclusion criteria

with acute or severe infection
suffering from serious primary diseases of heart, brain, liver and kidney, blood system, endocrine system and so on, and can not tolerate surgery
with histories of peripheral vascular disease, immunological disorder chronic alcoholism, and drug abuse and so on
with family history of genetic
allergic to collagen and chitosan
pregnancy and lactating women
serious damage existing in the skin and soft tissue in the operative region
bad adherence and can not return for follow-up visits on time as required