Comparison Of Outcome Of Wound Closure After Thyroid Surg... | NCT06485011

Studies
Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing

NCT06485011

Sponsor

Children Hospital and Institute of Child Health, Lahore

Status

Completed

Last Update Posted

Jul 3, 2024Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Pain, Acute Postoperative

Interventions

Paltysma suturing
Without Platysma suturing

Countries

Pakistan

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

Jun 2024

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

Jan 1, 2021Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Jun 26, 2024

First Submission Date that Met QC Criteria

Jun 26, 2024

First Posted Date

Jul 3, 2024Actual

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

Jun 26, 2024

Last Update Posted Date

Jul 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Muhammad Adeel Ashiq, Principal Investigator, Children Hospital and Institute of Child Health, LahorePrincipal Investigator

Lead Sponsor

Children Hospital and Institute of Child Health, LahoreOTHER

Collaborators

Not provided

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

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

Detailed Description

This randomized controlled trail was conducted at Surgical Ward from January 2021 to July 2021.

Materials and Methods Total 72 patients (indicated for thyroid surgery) who were fulfilling the inclusion criteria were enrolled. Patients were divided randomly into two groups by using lottery method. In Group A patients wound closure was done without Platysma Suturing and in Group-B patients wound closure was done with Platysma Suturing. Pain assessment was done with the help of VAS after surgery (6, Hours, 24 hours, 48 hours). Scar assessment was carried out with the help of POSAS. All this information was noted by the researcher himself and noted on a well-designed questionnaire.

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

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Paltysma suturing	Procedure	platysma muscle was sutured in this group with vicryl	With Platysma suturing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post operative Pain	Pain assessed on visual analogue scale. higher the VAS score means more pain and lower score mean less pain	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adeel Ashiq, MS	The Children Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children Hospital		Lahore	Punjab Province	42000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan of sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D002921	Cicatrix

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided