A Prospective, Double-Centre, Randomized, Evaluator/Subject-blinded, Control Clinical Study: to Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Trigger Finger Release Surgery

SciVision Biotech Inc.2 sites in 1 country5 target enrollmentMay 5, 2022

ConditionsTrigger Finger Hyaluronic Acid

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Trigger Finger
Sponsor: SciVision Biotech Inc.
Enrollment: 5
Locations: 2
Primary Endpoint: The percentage of Total Active Motion (TAM) score for target finger.
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To Evaluate the Effectiveness of the use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Trigger Finger Release Surgery

Detailed Description

The medical device is a bioabsorbable, extensible, crosslinked, 6% hyaluronic acid gel using fermentation sourced hyaluronic acid as a major component. This product could perfectly attach to the tissue surface, creating anti-adhesion layer which avoids post-surgical adhesion and is completely resorbed over time. This study is aimed to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after trigger finger release surgery.

Registry

clinicaltrials.gov

Start Date

May 5, 2022

End Date

April 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SciVision Biotech Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Agree to participate in this study and sign informed consent form
•Age 20 to 65 years of male or female
•The trigger finger, except thumb, classified as 3 to 4 points and plan to conduct trigger finger release surgery;
•The trigger finger, except thumb, classified as 2 points with the symptom of flexion contracture and plan to conduct trigger finger release surgery;
•Agree to comply with the follow-up schedule of this study

Exclusion Criteria

•Target finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, compression injury or other disease;
•Other fingers in the same hand as the target finger have other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
•Contralateral finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
•The operation site was conducted tendon transplantation or any surgery in past 6 months;
•Receiving orthopedic-related treatment which may affect the evaluation of the study;
•The skin of the operation site with infection, deficiency, or needing skin transplantation;
•With poorly controlled chronic diseases, such as diabetes mellitus;
•Patient with autoimmune disease (such as rheumatoid arthritis), malignant tumors, coagulation diseases, heart diseases, mental diseases, etc., may cause patients to participate in the trial at higher risk;
•Patient who has taken cortisol within the past 6 months, systemic corticosteroids within the past 2 months, immunosuppressive drugs within past 3 months, or non-steroidal anti-inflammatory drugs (NSAIDs) everyday within 1 week or NSAIDs within 8 hours occasionally. (subjects who have received inhaled/intranasal corticosteroids could be considered to include.);
•With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or taking blood circulation promotion and blood stasis removement medications within the past 10 days;

Outcomes

Primary Outcomes

The percentage of Total Active Motion (TAM) score for target finger.

Time Frame: 30 days post-operation

The percentage of Total Active Motion (TAM) score for target finger at 30 days post-operation.

Secondary Outcomes

The percentage of TAM score of target finger.(baseline, 14, 60, 90, and 180 days post-operation)
The grade of TAM score of target finger and contralateral finger.(baseline, 14, 30, 60, 90, and 180 days post-operation)
The evaluation of tendon by sonography.(baseline, 14, 30, 60, 90, and 180 days post-operation)
TAM score of target finger.(baseline, 14, 30, 60, 90, and 180 days post-operation)
Subjects self-evaluating Visual Analogue Scale (VAS) in pain of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.(baseline, 14, 30, 60, 90, and 180 days post-operation)
Subjects self-evaluating Visual Analogue Scale (VAS) in satisfaction(14, 30, 60, 90, and 180 days post-operation)
Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash).(baseline, 14, 30, 60, 90, and 180 days post-operation)
The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).(baseline, 14, 30, 60, 90, and 180 days post-operation)