ThyroidectomyPhase 1NCT05851560
Prospective Comparison of the Effect on Antiadhesive Barriers During Thyroid Surgery
A Phase 1 study testing Oxidized regenerated cellulose(ORC) and Hyaluronic acid(HA) in people with Thyroidectomy and Goiter, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroidectomy, Goiter, Thyroid Cancer
- What is being tested?
- Oxidized regenerated cellulose(ORC) and Hyaluronic acid(HA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 May 2023to 11 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating female patients.
- Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy.
- 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.
Show all 11Show fewer
- Participate are hypersensitive to anti-adhesion agents.
- Participate in another clinical trial within 1 month.
- Participate have drug or alcohol abuse.
- Patients' presence of surgical site infection or uncontrolled bleeding.
- Anticoagulant used within a week from surger
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-thyroid Surgery Adhesion Prevention Using Oxidized Regenerated Cellulose and Hyaluronic Acid: Prospective, Single-blinded, Randomized Study
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.
Read the detailed description
The postsurgical adhesions remain a significant cause of morbidity for a large number of patients in thyroid and parathyroid surgeries, despite use of meticulous surgical techniques and regardless of surgical access via conventional open or endoscopy. Such adhesions represent not only adhesion reformation at sites of adhesiolysis, but also de novo adhesion formation at sites of surgical procedures. A number of products, in the form of film or fluid, are used to prevent postoperative adhesion formation. These products normally serve as barriers to separate the contact of the damaged tissue surfaces in many animal models and some clinical practices. However, there are few evidences for surgeons to use or no use, or choose the suitable products in their clinical practice in neck surgeries. 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 . Local tissue inflammation processes initiate capillary leakage of serosanguineous fluid including clotting factors, and recruitment of macrophages and other cells, including fibroblasts. Cutting, fulguration, ligation of the macrovasculature and microvasculature leads to a state of tissue hypoxemia. Along with the accumulation of metabolic byproducts such as lactic acid, the lowering the pH of the injured tissue, and the conversion from aerobic to anaerobic metabolism within the injured tissues. Tissue hypoxia also results in creation of oxidative stress, with production of oxygen and nitrogen free radicals, which can result in DNA mutations, alterations of mitochondrial DNA, and generation of oxidized proteins.
Subsequently induce lipid peroxidation and protein nitration. The known factors involved in the inflammatory-like response that lead to adhesion development, are type 1 collagen, transforming growth factor b1 (TGF-b1), tumor necrosis factor a (TNF-a), interleukin 6 (IL-6), and vascular endothelial growth factor (VEGF). Of note, the scavenging of free radicals such as superoxide by superoxide dismutase can prevent the development of the adhesion phenotype . Other processes affected include plasminogen activator activity (PAA) (a function of tissue plasminogen activator and its inhibitor, plasminogen activator inhibitor-1), metalloproteinase activity, and extracellular matrix deposition (such as collagen 1, collagen 3, and fibronectin). There is also initiation of processes leading to angiogenesis, which can lead to new vessel formation that could resupply oxygen to these tissues as well as remove metabolic byproducts.
- Conditions
- Thyroidectomy, Goiter, Thyroid Cancer
- Being tested
- Oxidized regenerated cellulose(ORC), Hyaluronic acid(HA)
- Medical subject headings
- Goiter, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxidized regenerated cellulose(ORC)Drug
Also called Anti-Adhesion Agent
Investigate the antiadhesive effect of multiple antiadhesive barriers in thyroid surgery
Hyaluronic acid(HA)Drug
Also called Anti-Adhesion Agent
Hyaluronic acid(HA)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | control group that does not use antiadhesive material |
| Oxidized regenerated cellulose(ORC) Group | Experimental | The group that uses Oxidized regenerated cellulose(ORC) as antiadhesive material during thyroid surgery. Receives: Drug: Oxidized regenerated cellulose(ORC) |
| Hyaluronic acid(HA) Group | Experimental | The group that uses Hyaluronic acid(HA) as antiadhesive material during thyroid surgery. Receives: Drug: Hyaluronic acid(HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
Measured: pre-operation
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
Measured: post-operation(week 2)
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
Measured: post-operation( month1)
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
Measured: post-operation(month 6)
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
Measured: post-operation( month12)
Secondary outcomes (4)
Adhesion severity
Evaluate the adhesion severity by using questionnaires
Measured: post-operation(week 2)
Adhesion severity
Evaluate the adhesion severity by using questionnaires
Measured: post-operation(month1)
Adhesion severity
Evaluate the adhesion severity by using questionnaires
Measured: post-operation(month 6)
Adhesion severity
Evaluate the adhesion severity by using questionnaires
Measured: post-operation(month12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start24 May 2023
- Primary completion13 Sep 2023
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Hsun Wu, Study chair, MD，PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851560
- Sponsor's protocol ID
- 202111057DINB
- Other IDs
- NTUH 113-CTC0004
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuo TC, Chen KY, Tsai YJ, Lin MT, Chang CH, Wu MH. Post-thyroid surgery adhesion prevention using oxidized regenerated cellulose and hyaluronic acid: prospective, single-blinded, randomized study. BJS Open. 2025 Jul 1;9(4):zraf079. doi: 10.1093/bjsopen/zraf079.
PubMed 40613790
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-thyroid Surgery Adhesion Prevention Using Oxidized Regenerated Cellulose and Hyaluronic Acid: Prospective, Single-blinded, Randomized Study
- ClinicalTrials.gov ID
- NCT05851560
- Acronym / sponsor ID
- 202111057DINB
- Conditions
- Thyroidectomy, Goiter, Thyroid Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The postsurgical adhesions remain a significant cause of morbidity for a large number of patients in thyroid and parathyroid surgeries, despite use of meticulous surgical techniques and regardless of surgical access via conventional open or endoscopy. Such adhesions represent not only adhesion reformation at sites of adhesiolysis, but also de novo adhesion formation at sites of surgical procedures. A number of products, in the form of film or fluid, are used to prevent postoperative adhesion formation. These products normally serve as barriers to separate the contact of the damaged tissue surfaces in many animal models and some clinical practices. However, there are few evidences for surgeons to use or no use, or choose the suitable products in their clinical practice in neck surgeries. 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 . Local tissue inflammation processes initiate capillary leakage of serosanguineous fluid including clotting factors, and recruitment of macrophages and other cells, including fibroblasts. Cutting, fulguration, ligation of the macrovasculature and microvasculature leads to a state of tissue hypoxemia. Along with the accumulation of metabolic byproducts such as lactic acid, the lowering the pH of the injured tissue, and the conversion from aerobic to anaerobic metabolism within the injured tissues. Tissue hypoxia also results in creation of oxidative stress, with production of oxygen and nitrogen free radicals, which can result in DNA mutations, alterations of mitochondrial DNA, and generation of oxidized proteins.
Subsequently induce lipid peroxidation and protein nitration. The known factors involved in the inflammatory-like response that lead to adhesion development, are type 1 collagen, transforming growth factor b1 (TGF-b1), tumor necrosis factor a (TNF-a), interleukin 6 (IL-6), and vascular endothelial growth factor (VEGF). Of note, the scavenging of free radicals such as superoxide by superoxide dismutase can prevent the development of the adhesion phenotype . Other processes affected include plasminogen activator activity (PAA) (a function of tissue plasminogen activator and its inhibitor, plasminogen activator inhibitor-1), metalloproteinase activity, and extracellular matrix deposition (such as collagen 1, collagen 3, and fibronectin). There is also initiation of processes leading to angiogenesis, which can lead to new vessel formation that could resupply oxygen to these tissues as well as remove metabolic byproducts.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –control group that does not use antiadhesive material |
| Oxidized regenerated cellulose(ORC) Group | Experimental | Drug: Oxidized regenerated cellulose(ORC)The group that uses Oxidized regenerated cellulose(ORC) as antiadhesive material during thyroid surgery. |
| Hyaluronic acid(HA) Group | Experimental | Drug: Hyaluronic acid(HA)The group that uses Hyaluronic acid(HA) as antiadhesive material during thyroid surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Pregnant or lactating female patients.
- Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxidized regenerated cellulose(ORC)Also: Anti-Adhesion AgentInvestigate the antiadhesive effect of multiple antiadhesive barriers in thyroid surgery | Drug | Oxidized regenerated cellulose(ORC) Group |
| Hyaluronic acid(HA)Also: Anti-Adhesion AgentHyaluronic acid(HA) | Drug | Hyaluronic acid(HA) Group |
Primary outcome
Chinese version of Dysphagia Handicap Index(DHI)
Time frame: pre-operation
Evaluate the swallowing difficulty
Chinese version of Dysphagia Handicap Index(DHI)
Time frame: post-operation(week 2)
Evaluate the swallowing difficulty
Chinese version of Dysphagia Handicap Index(DHI)
Time frame: post-operation( month1)
Evaluate the swallowing difficulty
Chinese version of Dysphagia Handicap Index(DHI)
Time frame: post-operation(month 6)
Evaluate the swallowing difficulty
Chinese version of Dysphagia Handicap Index(DHI)
Time frame: post-operation( month12)
Evaluate the swallowing difficulty
4 secondary outcomes
Adhesion severity
Time frame: post-operation(week 2)
Adhesion severity
Time frame: post-operation(month1)
Adhesion severity
Time frame: post-operation(month 6)
Adhesion severity
Time frame: post-operation(month12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 40613790Kuo TC, Chen KY, Tsai YJ, Lin MT, Chang CH, Wu MH. Post-thyroid surgery adhesion prevention using oxidized regenerated cellulose and hyaluronic acid: prospective, single-blinded, randomized study. BJS Open. 2025 Jul 1;9(4):zraf079. doi: 10.1093/bjsopen/zraf079.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Hsun Wu study chair
MD，PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxidized regenerated cellulose(ORC) and Hyaluronic acid(HA) in people with Thyroidectomy and Goiter, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of Dysphagia Handicap Index(DHI) (time frame: pre-operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.