NCT05851560CompletedPhase 1
Prospective Comparison of the Effect on Antiadhesive Barriers During Thyroid Surgery
Post-thyroid Surgery Adhesion Prevention Using Oxidized Regenerated Cellulose and Hyaluronic Acid: Prospective, Single-blinded, Randomized Study
Source: ClinicalTrials.gov · Last updated 19 Sept 2025
Brief summary (registry, in English)
Despite use of meticulous surgical techniques and regardless of surgical access via conventional open or endoscopy, postoperative adhesions develop in the vast majority of patients undergoing neck surgery. Such adhesions represent not only adhesion reformation at sites of adhesiolysis, but also de novo adhesion formation at sites of surgical procedures. Improved understanding of the pathophysiology of adhesion development and distinguishing variations in the molecular biologic mechanisms represent future opportunities to improve the reduction of postoperative adhesions. After surgical tissue injury, there were local release of histamine, cytokines, and growth factors that lead to adhesion development. Other than survival or safety issues, cosmetics concerns and quality of life are the motifs after thyroid surgeries currently. Pos-thyroidectomy adhesions include various symptoms such as neck discomfort, neck tightness, skin adhesion to the trachea, skin scarring from adhesive reaction, and vocal cord palsy or impairment of laryngeal vertical movement. Relief of the adhesion through wound massage or anti-adhesion agents could reduce neck discomfort and voice changes.Although oxidized regenerated cellulose (ORC) and hyaluronic acid (HA) appeared to be safe and effective to decrease the incidence of adhesions, to improve adhesion-related neck discomfort, and to prevent skin adhesion to the trachea after neck surgery. The application of antiadhesive barriers after neck surgery is safe but the effect is still uncertain. Thus, we aim to confirm the antiadhesive effect of multiple antiadhesive barriers in thyroid/parathyroid surgery.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 17 Apr 2023
- Start date
- 24 May 2023
- Primary completion date
- 13 Sept 2023
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Thyroid cancer
- NCT number
- NCT05851560
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 45
- From 24 May 2023 to the primary completion date, 13 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent diseases/conditions which will be unable to evaluate the outcomes.
- Patients with previous neck radiotherapy within 1 year.
- Patients receiving any adhesion prevention adjuvant.
- Previous history of Keloid or hypertrophic scar.
- Participate have drug or alcohol abuse.
Other illness
- Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy.
- Patients' presence of surgical site infection or uncontrolled bleeding.
Other
- Pregnant or lactating female patients.
- Participate are hypersensitive to anti-adhesion agents.
- Participate in another clinical trial within 1 month.
- Anticoagulant used within a week from surger
Who the study is looking for
- Age more than 20 years of age.
- Patients diagnosed with benign goiter or thyroid cancer that will undergo open thyroidectomy (either unilateral or bilateral total thyroidectomy with or without central lymph node dissection).
- Naïve patients to thyroid surgery.
- Subjects are willing to comply with all aspects of the study and have signed informed consent form.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.