Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

June 14, 2017

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed

23 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed

Last Updated

December 19, 2018

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

November 26, 2018

Last Update Submit

December 17, 2018

Conditions

Peripheral Nerve Injuries

Keywords

scaffoldPeripheral nerve injuresrepairsafetyeffectiveness

Outcome Measures

Primary Outcomes (50)

Observing the condition of the healing of local wound with the naked eye at 2 weeks after operation，including redness, exudation and ulceration.
The condition of the healing of local wound will be observed by the designated doctor with the naked eye to see if there is redness, exudation or ulceration. And then the condition will be recorded.
2 weeks after operation
Learning about patients' systemic reactions by asking them at 2 weeks after operation, including fever, nausea, vomiting and skin itching.
The patients will be asked if there is systemic discomfort or any other bad reactions during the 2 weeks, including fever, nausea, vomiting and skin itching. And then the condition will be recorded.
2 weeks after operation
Test of white blood cell count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
2 weeks after operation
Test of lymphocyte count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
2 weeks after operation
Test of red blood cell count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
2 weeks after operation
Test of hemoglobin concentration at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
2 weeks after operation
Test of platelet count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
2 weeks after operation
Test of alanine aminotransferase at 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
2 weeks after operation
Test of aspartate aminotransferase at 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
2 weeks after operation
Test of serum creatinine at 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
2 weeks after operation
Test of blood urea nitrogen at 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
2 weeks after operation
Test of prothrombin time at 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
2 weeks after operation
Test of activated partial thromboplastin time at 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
2 weeks after operation
Test of thrombin time at 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
2 weeks after operation
Examination of the position sense at 3 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
3 months after operation
Examination of the movement sense at 3 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
3 months after operation
Examination of the sense of light touch at 3 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
3 months after operation
Examination of the sense of pain at 3 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
3 months after operation
Examination of the sense of temperature at 3 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
3 months after operation
Examination of static two-point discrimination at 3 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
3 months after operation
Test of white blood cell count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
3 months after operation
Test of lymphocyte count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
3 months after operation
Test of red blood cell count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
3 months after operation
Test of hemoglobin concentration at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
3 months after operation
Test of platelet count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
3 months after operation
Test of alanine aminotransferase at 3 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
3 months after operation
Test of aspartate aminotransferase at 3 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
3 months after operation
Test of serum creatinine at 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
3 months after operation
Test of blood urea nitrogen at 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
3 months after operation
Test of prothrombin time at 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
3 months after operation
Test of activated partial thromboplastin time at 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
3 months after operation
Test of thrombin time at 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
3 months after operation
Examination of the position sense at 6 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
6 months after operation
Examination of the movement sense at 6 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
6 months after operation
Examination of the sense of light touch at 6 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
6 months after operation
Examination of the sense of pain at 6 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
6 months after operation
Examination of the sense of temperature at 6 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
6 months after operation
Examination of static two-point discrimination at 6 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
6 months after operation
Test of white blood cell count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
6 months after operation
Test of lymphocyte count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
6 months after operation
Test of red blood cell count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
6 months after operation
Test of hemoglobin concentration at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
6 months after operation
Test of platelet count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
6 months after operation
Test of alanine aminotransferase at 6 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
6 months after operation
Test of aspartate aminotransferase at 6 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
6 months after operation
Test of serum creatinine at 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
6 months after operation
Test of blood urea nitrogen at 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
6 months after operation
Test of prothrombin time at 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
6 months after operation
Test of activated partial thromboplastin time at 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
6 months after operation
Test of thrombin time at 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
6 months after operation

Study Arms (2)

nerve scaffold group

EXPERIMENTAL

the experimental group of cases with peripheral sensory nerve injuries will be treated with nerve scaffold.

Device: nerve scaffold

non-nerve scaffold group

NO INTERVENTION

the control group of cases will be treated without nerve scaffold.

Interventions

nerve scaffoldDEVICE

It is a new kind of nerve scaffold with the microstructure of longitudinally oriented microchannels. It's made of collagen as the main raw material.

nerve scaffold group

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Xijing Hospitallead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

Zhuo j Luo, MD
Xijing Hospital
STUDY CHAIR
Rui Cong, MD
Xijing Hospital
STUDY DIRECTOR

Central Study Contacts

Jing h Huang, MD

CONTACT

13572066464 huangjh@fmmu.edu.cn

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

December 19, 2018

Study Start

June 14, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 19, 2018

Record last verified: 2017-12

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (50)

Study Arms (2)

nerve scaffold group

non-nerve scaffold group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations