Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision

Thyroid Neoplasms Clinical Trial

— SCSvsSG  

Official title:

Comparison of Esthetic Results Between Subcuticular Suture and Synthetic Glue in Thyroidectomy Incision: a RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754182
• Other study ID #: 2454/C.E.
• Status: Completed
• Phase: N/A
• First received: September 16, 2008
• Last updated: May 3, 2010
• Start date: September 2008
• Est. completion date: May 2010

Study information

• Verified date: March 2009
• Source: Azienda Ospedaliera - Universitaria di Modena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Goiter
• Parathyroid Pathologies
• Thyroid Neoplasms

Intervention

Device:
• Octylcyanoacrylate (Dermabond)
Synthetic glue for surgical use (skin closure)
• Subcuticular reabsorbable suture (Caprosyn)
Every stitch is positioned in the subcuticular tissue by a continuous technique

Locations

Country	Name	City	State
Italy	Policlinico di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera - Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)		10 days	No
Secondary	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)		3 months	No