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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03108742
Enrollment
37
Registered
2017-04-11
Start date
2016-10-01
Completion date
2019-01-28
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy, Pain, Esthetic, Dermal Stapler

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.

Interventions

DEVICEINSORB

dermal stapler for skin closure

PROCEDUREclassic intradermal suture

intradermal suture for skin closure

Sponsors

Inje University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Manchester Scar Scale (MSS)Change from Baseline scar at 6 monthsEvaluate scar
Visual Analogue Scale (VAS)Change from Baseline pain at 6 monthsEvaluate pain
Modified Stony Brook Scar Evaluation Scale (SBES)Change from Baseline scar at 6 monthsEvaluate scar

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026