poor enrollment

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

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.

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.