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

Sponsored by:	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 vs 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)

MedlinePlus related topics: Cancer Scars Thyroid Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Esthetic Results Between Subcuticular Suture and Synthetic Glue in Thyroidectomy Incision: a RCT

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

Primary 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: 1 ] [ 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: 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with synthetic glue	Device: Octylcyanoacrylate (Dermabond) Synthetic glue for surgical use (skin closure)
B: Active Comparator 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

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

Contacts

Contact: Matteo Alicandri-Ciufelli, MD

+393470585750

matteo.alicandri@hotmail.it

Locations

Italy
Policlinico di Modena	Recruiting
Modena, Italy, 41100
Contact: Matteo Alicandri-Ciufelli, MD +393470585750 matteo.alicandri@hotmail.it
Contact: Matteo Alicandri-Ciufelli, MD +393470585750 matteo.alicandri@hotmail.it
Principal Investigator: Matteo Alicandri-Ciufelli, MD
Sub-Investigator: Gabriele Molteni, MD
Sub-Investigator: Alessia Piccinini, MD
Sub-Investigator: Francesco Mattioli, MD
Sub-Investigator: Alberto Grammatica, MD

Sponsors and Collaborators

Azienda Ospedaliera - Universitaria di Modena

Investigators

Principal Investigator:

Matteo Alicandri-Ciufelli, MD

Otorinolaringoiatria, Policlinico di Modena

More Information

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

Keywords provided by Azienda Ospedaliera - Universitaria di Modena:

thyroidectomy
surgery
synthetic glue
subcuticular suture

Study placed in the following topic categories:

Goiter
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009