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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03108742
Other study ID # 2016-12-010-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date January 28, 2019

Study information

Verified date February 2019
Source Inje University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date January 28, 2019
Est. primary completion date January 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
INSORB
dermal stapler for skin closure
Procedure:
classic intradermal suture
intradermal suture for skin closure

Locations

Country Name City State
Korea, Republic of Dongsik Bae Busan

Sponsors (1)

Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Stony Brook Scar Evaluation Scale (SBES) Evaluate scar Change from Baseline scar at 6 months
Primary Manchester Scar Scale (MSS) Evaluate scar Change from Baseline scar at 6 months
Primary Visual Analogue Scale (VAS) Evaluate pain Change from Baseline pain at 6 months
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