Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision (SCSvsSG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754182
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : May 5, 2010
Information provided by:
Azienda Ospedaliero-Universitaria di Modena

Brief 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 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.

Condition or disease Intervention/treatment Phase
Goiter Thyroid Neoplasms Parathyroid Pathologies Device: Octylcyanoacrylate (Dermabond) Device: Subcuticular reabsorbable suture (Caprosyn) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Comparison of Esthetic Results Between Subcuticular Suture and Synthetic Glue in Thyroidectomy Incision: a RCT
Study Start Date : September 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: A
Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with synthetic glue
Device: Octylcyanoacrylate (Dermabond)
Synthetic glue for surgical use (skin closure)
Other Name: Dermabond

Active Comparator: B
Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with subcuticular suture
Device: Subcuticular reabsorbable suture (Caprosyn)
Every stitch is positioned in the subcuticular tissue by a continuous technique
Other Name: Caprosyn

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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) [ Time Frame: 3 months ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy

Exclusion Criteria:

  • Former neck operations with external incisions
  • Post-operative bleeding
  • Cervical nodes involvement (with the necessity of widened incisions)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00754182

Policlinico di Modena
Modena, Italy, 41100
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena
Principal Investigator: Matteo Alicandri-Ciufelli, MD Otorinolaringoiatria, Policlinico di Modena

Responsible Party: Matteo Alicandri-Ciufelli, U.O.C. Otorinolaringoiatria Azienda Ospedaliero-Univeritaria di Modena Identifier: NCT00754182     History of Changes
Other Study ID Numbers: 2454/C.E.
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: March 2009

Keywords provided by Azienda Ospedaliero-Universitaria di Modena:
synthetic glue
subcuticular suture

Additional relevant MeSH terms:
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases