Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision - Full Text View

Sponsor:	Azienda Ospedaliera - Universitaria di Modena
Information provided by:	Azienda Ospedaliera - Universitaria di Modena
ClinicalTrials.gov Identifier:	NCT00754182

Purpose

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	Intervention
Goiter Thyroid Neoplasms Parathyroid Pathologies	Device: Octylcyanoacrylate (Dermabond) Device: Subcuticular reabsorbable suture (Caprosyn)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	Comparison of Esthetic Results Between Subcuticular Suture and Synthetic Glue in Thyroidectomy Incision: a RCT

Resource links provided by NLM:

MedlinePlus related topics: Cancer Scars Thyroid Cancer Thyroid Diseases

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera - Universitaria di Modena:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	September 2008
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754182

Locations

Italy
Policlinico di Modena
Modena, Italy, 41100

Sponsors and Collaborators

Azienda Ospedaliera - Universitaria di Modena

Investigators

Principal Investigator:

Matteo Alicandri-Ciufelli, MD

Otorinolaringoiatria, Policlinico di Modena

More Information

No publications provided

Responsible Party:	Matteo Alicandri-Ciufelli, U.O.C. Otorinolaringoiatria Azienda Ospedaliero-Univeritaria di Modena
ClinicalTrials.gov Identifier:	NCT00754182 History of Changes
Other Study ID Numbers:	2454/C.E.
Study First Received:	September 16, 2008
Last Updated:	May 3, 2010
Health Authority:	Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera - Universitaria di Modena:

thyroidectomy
surgery
synthetic glue
subcuticular suture

Additional relevant MeSH terms:

Neoplasms
Thyroid Neoplasms
Goiter
Endocrine Gland Neoplasms

Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on February 09, 2012