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SCSvsSG: Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision

Sponsor
Azienda Ospedaliero-Universitaria di Modena (Other)
Overall Status
Completed
CT.gov ID
NCT00754182
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
19.9
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Octylcyanoacrylate (Dermabond)
  • Device: Subcuticular reabsorbable suture (Caprosyn)
 N/A

Study Design

Study Type:
Interventional
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 :
Sep 1, 2008
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

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 Names:
  • 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 Names:
  • Caprosyn

    		•

    Outcome Measures

    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.) [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) [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Policlinico di Modena Modena Italy 41100

    Sponsors and Collaborators

    • Azienda Ospedaliero-Universitaria di Modena

    Investigators

    • Principal Investigator: Matteo Alicandri-Ciufelli, MD, Otorinolaringoiatria, Policlinico di Modena

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00754182
    Other Study ID Numbers:
    • 2454/C.E.
    First Posted:
    Sep 17, 2008
    Last Update Posted:
    May 5, 2010
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    thyroidectomy
    surgery
    synthetic glue
    subcuticular suture
    Additional relevant MeSH terms:
    Thyroid Neoplasms

    Study Results

    No Results Posted as of May 5, 2010