Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery

NCT ID: NCT05082480

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2023-04-28

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.

Conditions

Trigger Finger; Hyaluronic Acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Hyaluronic acid (HA)

Hyaluronic acid (HA)

Group Type: EXPERIMENTAL

Hyaluronic acid (HA)

Intervention Type: DEVICE

Hyaluronic acid (HA)

Saline

Saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DEVICE

Saline

Interventions

Hyaluronic acid (HA)

Hyaluronic acid (HA)

Intervention Type: DEVICE

Saline

Saline

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SciVision Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

RDCT-TWDH

Identifier Type: -

Identifier Source: org_study_id