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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108742
• Other study ID #: 2016-12-010-001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dermal Stapler
• Esthetic
• Pain
• Thyroidectomy

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