Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy

NCT ID: NCT03108742

Last Updated: 2019-02-25

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2019-01-28

Brief Summary

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In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. This is a study to see if there is any difference in pain and esthetics in scar formation of these groups.

Detailed Description

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Conditions

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Thyroidectomy Pain Esthetic Dermal Stapler

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dermal stapler

Group Type EXPERIMENTAL

INSORB

Intervention Type DEVICE

dermal stapler for skin closure

classic intradermal suture

Group Type ACTIVE_COMPARATOR

classic intradermal suture

Intervention Type PROCEDURE

intradermal suture for skin closure

Interventions

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INSORB

dermal stapler for skin closure

Intervention Type DEVICE

classic intradermal suture

intradermal suture for skin closure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient who will have thyroid surgery

Exclusion Criteria

1. done thyroid surgery before
2. done any radiotherapy on neck
3. who needs neck dissection
4. laparoscopic ot robotic surgery
5. under 18 years old or over 70 years old
6. bad general condition, high American Society of Anesthesiologists (ASA) score (over 3)
7. who used immunosuppressive drugs in 6 months
8. breast feeder or pregnancy
9. who disagrees to do this trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Dongsik Bae

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dongsik Bae

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2016-12-010-001

Identifier Type: -

Identifier Source: org_study_id

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