Pain, Acute PostoperativeNCT06485011
Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing
A study testing Paltysma suturing and Without Platysma suturing in people with Pain, Acute Postoperative, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
Trial summary
Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing in terms of wound scar and pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute Postoperative
- What is being tested?
- Paltysma suturing and Without Platysma suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- : Both men and women patients in the age range (20-70 years) undergoing primary thyroid surgery were included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing in terms of wound scar and pain.
Read the 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.
- Conditions
- Pain, Acute Postoperative
- Being tested
- Paltysma suturing, Without Platysma suturing
- Keywords
- Thyroid surgery, scar, visual analog scale
- Medical subject headings
- Pain, Postoperative, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paltysma suturingProcedure or surgery
platysma muscle was sutured in this group with vicryl
Without Platysma suturingProcedure or surgery
platysma muscle was not sutured in this group
| Study group | Role | What they receive |
|---|---|---|
| With Platysma suturing | Experimental | platysma muscle was sutured in this group Receives: Procedure: Paltysma suturing |
| Without Platysma suturing | Experimental | platysma muscle was not sutured in this group Receives: Procedure: Without Platysma suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Pain
Pain assessed on visual analogue scale. higher the VAS score means more pain and lower score mean less pain
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2021
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Acute PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups included
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children Hospital and Institute of Child Health, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore
- Investigators
- Adeel Ashiq, MS, Principal investigator, The Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485011
- Sponsor's protocol ID
- Adeel7
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan of sharing
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing
- ClinicalTrials.gov ID
- NCT06485011
- Acronym / sponsor ID
- Adeel7
- Conditions
- Pain, Acute Postoperative
- Keywords
- Thyroid surgery, scar, visual analog scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Children Hospital and Institute of Child Health, LahoreUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups included
| Arm | Type | Receives |
|---|---|---|
| With Platysma suturing | Experimental | Procedure: Paltysma suturingplatysma muscle was sutured in this group |
| Without Platysma suturing | Experimental | Procedure: Without Platysma suturingplatysma muscle was not sutured in this group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- : Both men and women patients in the age range (20-70 years) undergoing primary thyroid surgery were included.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paltysma suturingplatysma muscle was sutured in this group with vicryl | Procedure or surgery | With Platysma suturing |
| Without Platysma suturingplatysma muscle was not sutured in this group | Procedure or surgery | Without Platysma suturing |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No. No plan of sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeel Ashiq, MS principal investigator
The Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paltysma suturing and Without Platysma suturing in people with Pain, Acute Postoperative, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative Pain (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.