Clinical trial NCT05082480: Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Trigger Finger
Hyaluronic Acid
Lead sponsor: SciVision Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Target finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, compression injury or other disease;
2. Other fingers in the same hand as the target finger have other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
3. Contralateral finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
4. The operation site was conducted tendon transplantation or any surgery in past 6 months;
5. Receiving orthopedic-related treatment which may affect the evaluation of the study;
6. The skin of the operation site with infection, deficiency, or needing skin transplantation;
7. With poorly controlled chronic diseases, such as diabetes mellitus;
8. 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;
9. 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.);
10. With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or taking blood circulation promotion and blood stasis removement medications within the past 10 days;
11. With history of hypersensitivity or allergy to hyaluronic acid or any component of the device; With history of hypersensitivity or allergy to Gram-positive bacteria or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study;
12. Pregnant, planning pregnancy or in breastfeeding females;
13. Other circumstances which judged to be unsuitable for participating in the study by the investigator.

Primary outcomes:
measure: The percentage of Total Active Motion (TAM) score for target finger.
timeFrame: 30 days post-operation
Secondary outcomes:
measure: The percentage of TAM score of target finger.
timeFrame: baseline, 14, 60, 90, and 180 days post-operation
measure: TAM score of target finger.
timeFrame: baseline, 14, 30, 60, 90, and 180 days post-operation
measure: The grade of TAM score of target finger and contralateral finger.
timeFrame: baseline, 14, 30, 60, 90, and 180 days post-operation
measure: Subjects self-evaluating Visual Analogue Scale (VAS) in pain of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.
timeFrame: baseline, 14, 30, 60, 90, and 180 days post-operation
measure: Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash).
timeFrame: baseline, 14, 30, 60, 90, and 180 days post-operation
measure: The evaluation of tendon by sonography.
timeFrame: baseline, 14, 30, 60, 90, and 180 days post-operation
measure: Subjects self-evaluating Visual Analogue Scale (VAS) in satisfaction
timeFrame: 14, 30, 60, 90, and 180 days post-operation
measure: The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).
timeFrame: baseline, 14, 30, 60, 90, and 180 days post-operation
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Ta-Tung Hospital
Study officials:
References: