Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision

NCT ID: NCT00754182

Last Updated: 2010-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Goiter Thyroid Neoplasms Parathyroid Pathologies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with synthetic glue

Group Type EXPERIMENTAL

Octylcyanoacrylate (Dermabond)

Intervention Type DEVICE

Synthetic glue for surgical use (skin closure)

B

Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with subcuticular suture

Group Type ACTIVE_COMPARATOR

Subcuticular reabsorbable suture (Caprosyn)

Intervention Type DEVICE

Every stitch is positioned in the subcuticular tissue by a continuous technique

Interventions

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Octylcyanoacrylate (Dermabond)

Synthetic glue for surgical use (skin closure)

Intervention Type DEVICE

Subcuticular reabsorbable suture (Caprosyn)

Every stitch is positioned in the subcuticular tissue by a continuous technique

Intervention Type DEVICE

Other Intervention Names

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Dermabond Caprosyn

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role lead

Responsible Party

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U.O.C. Otorinolaringoiatria Azienda Ospedaliero-Univeritaria di Modena

Principal Investigators

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Matteo Alicandri-Ciufelli, MD

Role: PRINCIPAL_INVESTIGATOR

Otorinolaringoiatria, Policlinico di Modena

Locations

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Policlinico di Modena

Modena, Modena, Italy

Site Status

Countries

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Italy

Other Identifiers

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2454/C.E.

Identifier Type: -

Identifier Source: org_study_id

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