- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06485011
Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 42000
- The Children Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: With Platysma suturing
platysma muscle was sutured in this group
|
platysma muscle was sutured in this group with vicryl
|
|
Experimental: Without Platysma suturing
platysma muscle was not sutured in this group
|
platysma muscle was not sutured in this group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative Pain
Time Frame: 48 hours
|
Pain assessed on visual analogue scale.
higher the VAS score means more pain and lower score mean less pain
|
48 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Adeel Ashiq, MS, The Children Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adeel7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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