ThyroidectomyNCT03108742
Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy
A study testing INSORB and classic intradermal suture in people with Thyroidectomy and Pain, run by Inje University at 1 site in South Korea.
Trial summary
In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroidectomy, Pain, Esthetic
- What is being tested?
- INSORB and classic intradermal suture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2016to 28 Jan 2019
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who will have thyroid surgery
Who cannot join
- done thyroid surgery before
- done any radiotherapy on neck
- who needs neck dissection
- laparoscopic ot robotic surgery
- under 18 years old or over 70 years old
- bad general condition, high American Society of Anesthesiologists (ASA) score (over 3)
Show all 9Show fewer
- who used immunosuppressive drugs in 6 months
- breast feeder or pregnancy
- who disagrees to do this trial
Trial locations and contacts
1 site in 1 country.
About this study
In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. This is a study to see if there is any difference in pain and esthetics in scar formation of these groups.
- Conditions
- Thyroidectomy, Pain, Esthetic, Dermal Stapler
- Being tested
- INSORB, classic intradermal suture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSORBDevice
dermal stapler for skin closure
classic intradermal sutureProcedure or surgery
intradermal suture for skin closure
| Study group | Role | What they receive |
|---|---|---|
| dermal stapler | Experimental | Not described Receives: Device: INSORB |
| classic intradermal suture | Active comparator | Not described Receives: Procedure: classic intradermal suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Stony Brook Scar Evaluation Scale (SBES)
Evaluate scar
Measured: Change from Baseline scar at 6 months
Manchester Scar Scale (MSS)
Evaluate scar
Measured: Change from Baseline scar at 6 months
Visual Analogue Scale (VAS)
Evaluate pain
Measured: Change from Baseline pain at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Oct 2016
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongsik Bae, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108742
- Sponsor's protocol ID
- 2016-12-010-001
- Status last verified
- Feb 2019
- First submitted
- 20 Mar 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy
- ClinicalTrials.gov ID
- NCT03108742
- Acronym / sponsor ID
- 2016-12-010-001
- Conditions
- Thyroidectomy, Pain, Esthetic, Dermal Stapler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 11 Apr 2017 (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.
In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. This is a study to see if there is any difference in pain and esthetics in scar formation of these groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dermal stapler | Experimental | Device: INSORB |
| classic intradermal suture | Active comparator | Procedure: classic intradermal suture |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who will have thyroid surgery
Key exclusion criteria (9 listed)
- done thyroid surgery before
- done any radiotherapy on neck
- who needs neck dissection
- laparoscopic ot robotic surgery
- under 18 years old or over 70 years old
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 |
|---|---|---|
| INSORBdermal stapler for skin closure | Device | dermal stapler |
| classic intradermal sutureintradermal suture for skin closure | Procedure or surgery | classic intradermal suture |
Primary outcome
Modified Stony Brook Scar Evaluation Scale (SBES)
Time frame: Change from Baseline scar at 6 months
Evaluate scar
Manchester Scar Scale (MSS)
Time frame: Change from Baseline scar at 6 months
Evaluate scar
Visual Analogue Scale (VAS)
Time frame: Change from Baseline pain at 6 months
Evaluate pain
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 25 Feb 2019.
Related trials for Thyroidectomy
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
RecruitingPhase 4
Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
Tracheal Extubation, Cough
Enrolling by invitation
Effect of Cold Water Spray on Swallowing Difficulty, Pain, and Thirst After Thyroid Surgery
Swallowing Difficulties, Thirst
RecruitingPhase 2
Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients
Head and Neck Disorder, Head and Neck Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSORB and classic intradermal suture in people with Thyroidectomy and Pain, run by Inje University at 1 site in South Korea.
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 1 inclusion and 9 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 25 Feb 2019. 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 South Korea. 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.
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?
Modified Stony Brook Scar Evaluation Scale (SBES) (time frame: Change from Baseline scar at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2019.