Randomized Control Study of Dermal Staples vs Subcuticula... | NCT03108742

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

NCT03108742

Sponsor

Inje University

Status

Completed

Last Update Posted

Feb 25, 2019Actual

Enrollment

37Actual

Phase

Not Applicable

Conditions

Thyroidectomy
Pain
Esthetic
Dermal Stapler

Interventions

INSORB
classic intradermal suture

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016Actual

Primary Completion Date

Jan 28, 2019Actual

Completion Date

Jan 28, 2019Actual

First Submitted Date

Mar 20, 2017

First Submission Date that Met QC Criteria

Apr 5, 2017

First Posted Date

Apr 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2019

Last Update Posted Date

Feb 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dermal stapler	Experimental		Device: INSORB
classic intradermal suture	Active Comparator		Procedure: classic intradermal suture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INSORB	Device	dermal stapler for skin closure	dermal stapler
classic intradermal suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient who will have thyroid surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided