NCT03108742

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

March 20, 2017

Last Update Submit

February 21, 2019

Conditions

ThyroidectomyPainEstheticDermal Stapler

Outcome Measures

Primary Outcomes (3)

  • Modified Stony Brook Scar Evaluation Scale (SBES)

    Evaluate scar

    Change from Baseline scar at 6 months

  • Manchester Scar Scale (MSS)

    Evaluate scar

    Change from Baseline scar at 6 months

  • Visual Analogue Scale (VAS)

    Evaluate pain

    Change from Baseline pain at 6 months

Study Arms (2)

dermal stapler

EXPERIMENTAL
Device: INSORB

classic intradermal suture

ACTIVE COMPARATOR
Procedure: classic intradermal suture

Interventions

INSORBDEVICE

dermal stapler for skin closure

dermal stapler
classic intradermal suturePROCEDURE

intradermal suture for skin closure

classic intradermal suture

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who will have thyroid surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongsik Bae

Busan, South Korea

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2017

First Posted

April 11, 2017

Study Start

October 1, 2016

Primary Completion

January 28, 2019

Study Completion

January 28, 2019

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

KR(1)