Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision (SCSvsSG)

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera - Universitaria di Modena
ClinicalTrials.gov Identifier:
NCT00754182
First received: September 16, 2008
Last updated: May 3, 2010
Last verified: March 2009

September 16, 2008
May 3, 2010
September 2008
May 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00754182 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Goiter
  • Thyroid Neoplasms
  • Parathyroid Pathologies
  • Device: Octylcyanoacrylate (Dermabond)
    Synthetic glue for surgical use (skin closure)
    Other Name: Dermabond
  • Device: Subcuticular reabsorbable suture (Caprosyn)
    Every stitch is positioned in the subcuticular tissue by a continuous technique
    Other Name: Caprosyn
  • Experimental: A
    Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with synthetic glue
    Intervention: Device: Octylcyanoacrylate (Dermabond)
  • Active Comparator: B
    Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with subcuticular suture
    Intervention: Device: Subcuticular reabsorbable suture (Caprosyn)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2010
May 2010   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00754182
2454/C.E.
No
Matteo Alicandri-Ciufelli, U.O.C. Otorinolaringoiatria Azienda Ospedaliero-Univeritaria di Modena
Azienda Ospedaliera - Universitaria di Modena
Not Provided
Principal Investigator: Matteo Alicandri-Ciufelli, MD Otorinolaringoiatria, Policlinico di Modena
Azienda Ospedaliera - Universitaria di Modena
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP