GoiterSCSvsSGNCT00754182
Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision
A study testing Octylcyanoacrylate (Dermabond) and Subcuticular reabsorbable suture (Caprosyn) in people with Goiter and Thyroid Neoplasms, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
The aim of this study is to compare aesthetic results of two different type of sutures (subcuticular versus synthetic glue) in post-thyroidectomy incisions. It is a randomized clinical trial (single blinded) designed as a superiority study, since in the authors' hypotheses glue can give better results compared with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Goiter, Thyroid Neoplasms, Parathyroid Pathologies
- What is being tested?
- Octylcyanoacrylate (Dermabond) and Subcuticular reabsorbable suture (Caprosyn)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2008to May 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy
Who cannot join
- Former neck operations with external incisions
- Post-operative bleeding
- Cervical nodes involvement (with the necessity of widened incisions)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Esthetic Results Between Subcuticular Suture and Synthetic Glue in Thyroidectomy Incision: a RCT
The aim of this study is to compare aesthetic results of two different type of sutures (subcuticular versus synthetic glue) in post-thyroidectomy incisions. It is a randomized clinical trial (single blinded) designed as a superiority study, since in the authors' hypotheses glue can give better results compared with subcuticular suture in this particular district. Secondary objective is to investigate if other factors (like the use of cold/warm blade, the sex, the presence of diabetes, the lenght of incision) can influence aesthetic results.
- Conditions
- Goiter, Thyroid Neoplasms, Parathyroid Pathologies
- Being tested
- Octylcyanoacrylate (Dermabond), Subcuticular reabsorbable suture (Caprosyn)
- Keywords
- thyroidectomy, surgery, synthetic glue, subcuticular suture
- 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.
Octylcyanoacrylate (Dermabond)Device
Also called Dermabond
Synthetic glue for surgical use (skin closure)
Subcuticular reabsorbable suture (Caprosyn)Device
Also called Caprosyn
Every stitch is positioned in the subcuticular tissue by a continuous technique
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with synthetic glue Receives: Device: Octylcyanoacrylate (Dermabond) |
| B | Active comparator | Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with subcuticular suture Receives: Device: Subcuticular reabsorbable suture (Caprosyn) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar evaluation scale for short term esthetic results (Hollander, J. E., Singer, A. J., Valentine, S., and Henry, M. C. Wound registry: Development and validation. Ann. Emerg. Med. 25: 675, 1995.)
Measured: 10 days
Secondary outcomes (1)
Scar Evaluation Scale (by Adam J. Singer, M.D. et al. "Development and Validation of a Novel Scar Evaluation Scale" Plastic and Reconstructive Surgery ,December 2007 Volume 120, Number 7 ,1892-1897)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoiterStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Investigators
- Matteo Alicandri-Ciufelli, MD, Principal investigator, Otorinolaringoiatria, Policlinico di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754182
- Sponsor's protocol ID
- 2454/C.E.
- Acronym
- SCSvsSG
- Status last verified
- Mar 2009
- First submitted
- 16 Sep 2008
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Esthetic Results Between Subcuticular Suture and Synthetic Glue in Thyroidectomy Incision: a RCT
- ClinicalTrials.gov ID
- NCT00754182
- Acronym / sponsor ID
- SCSvsSG / 2454/C.E.
- Conditions
- Goiter, Thyroid Neoplasms, Parathyroid Pathologies
- Keywords
- thyroidectomy, surgery, synthetic glue, subcuticular suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Sep 2008 (estimated)
- 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.
The aim of this study is to compare aesthetic results of two different type of sutures (subcuticular versus synthetic glue) in post-thyroidectomy incisions. It is a randomized clinical trial (single blinded) designed as a superiority study, since in the authors' hypotheses glue can give better results compared with subcuticular suture in this particular district. Secondary objective is to investigate if other factors (like the use of cold/warm blade, the sex, the presence of diabetes, the lenght of incision) can influence aesthetic results.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Octylcyanoacrylate (Dermabond)Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with synthetic glue |
| B | Active comparator | Device: Subcuticular reabsorbable suture (Caprosyn)Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with subcuticular suture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy
Key exclusion criteria (3 listed)
- Former neck operations with external incisions
- Post-operative bleeding
- Cervical nodes involvement (with the necessity of widened incisions)
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 |
|---|---|---|
| Octylcyanoacrylate (Dermabond)Also: DermabondSynthetic glue for surgical use (skin closure) | Device | A |
| Subcuticular reabsorbable suture (Caprosyn)Also: CaprosynEvery stitch is positioned in the subcuticular tissue by a continuous technique | Device | B |
Primary outcome
Scar evaluation scale for short term esthetic results (Hollander, J. E., Singer, A. J., Valentine, S., and Henry, M. C. Wound registry: Development and validation. Ann. Emerg. Med. 25: 675, 1995.)
Time frame: 10 days
1 secondary outcome
Scar Evaluation Scale (by Adam J. Singer, M.D. et al. "Development and Validation of a Novel Scar Evaluation Scale" Plastic and Reconstructive Surgery ,December 2007 Volume 120, Number 7 ,1892-1897)
Time frame: 3 months
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 5 May 2010.
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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.
Matteo Alicandri-Ciufelli, MD principal investigator
Otorinolaringoiatria, Policlinico di Modena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octylcyanoacrylate (Dermabond) and Subcuticular reabsorbable suture (Caprosyn) in people with Goiter and Thyroid Neoplasms, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 3 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 5 May 2010. 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 Italy. 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?
Scar evaluation scale for short term esthetic results (Hollander, J. E., Singer, A. J., Valentine, S., and Henry, M. C. Wound registry: Development and validation. Ann. Emerg. Med. 25: 675, 1995.) (time frame: 10 days). 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 5 May 2010.