NCT06485011

Brief Summary

Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing in terms of wound scar and pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 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

January 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 26, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

Thyroid surgeryscarvisual analog scale

Outcome Measures

Primary Outcomes (1)

  • Post operative Pain

    Pain assessed on visual analogue scale. higher the VAS score means more pain and lower score mean less pain

    48 hours

Study Arms (2)

With Platysma suturing

EXPERIMENTAL

platysma muscle was sutured in this group

Procedure: Paltysma suturing

Without Platysma suturing

EXPERIMENTAL

platysma muscle was not sutured in this group

Procedure: Without Platysma suturing

Interventions

platysma muscle was sutured in this group with vicryl

With Platysma suturing

platysma muscle was not sutured in this group

Without Platysma suturing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • : Both men and women patients in the age range (20-70 years) undergoing primary thyroid surgery were included.

You may not qualify if:

  • Patients with disorders of wound healing, diabetes mellitus, Pre-operative known malignant condition, history of neck surgery or not willing to participate in the study were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children Hospital

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Conditions

Pain, PostoperativeCicatrix

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFibrosis

Study Officials

  • Adeel Ashiq, MS

    The Children Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups included
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

January 1, 2021

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

No plan of sharing

Locations