This study aims provide evidence about the most suitable tool to be used in oral and maxillofacial surgery for skin incisions in terms of incisional time, intraoperative blood loss due to incision, post-operative skin incision site pain occurring from both methods of skin incision.
Design
Two arm parallel group randomized trial with double blinding.Simple randomisation using a randomisation table created by computer software with allocation using concealed envelopes. A sample size of 82 with 41 in scalpel group and 41 in diathermy group at a tertiary care hospital.
Settings and conduct
At Combined Military Hospital Lahore and CMH Lahore Medical College and IOD
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients of any gender, within the age limit of 30-60 years, who underwent maxillofacial surgery including neck dissections, parotid surgery and maxillofacial trauma. Incision size between 2 to 10 cm will be included.
Exclusion Criteria: patients with signs of active wound infection and anaemia. Patients om anticoagulant or corticosteroid therapy, patients who already have an existing scar on the probable incision site. patients with known connective tissue disorder and predilection of keloid scars
Intervention groups
Incision shall be made using scalpel in scalpel group and diathermy for Incision in the diathermy group. Incision for maxillofacial surgery
Main outcome variables
Incision time during surgery, Perop blood loss measured during surgery, pain using visual analogue scale during patient follow ups for the next 3 months
General information
Reason for update
Acronym
Not applicable
IRCT registration information
IRCT registration number:IRCT20240101060587N1
Registration date:2024-01-28, 1402/11/08
Registration timing:registered_while_recruiting
Last update:2024-01-28, 1402/11/08
Update count:0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
Vaffa Khan
Name of organization / entity
College of Physicians and Surgeons Pakistan
Country
Pakistan
Phone
+92 321 4481828
Email address
vaffasaad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-15, 1402/10/25
Expected recruitment end date
2024-02-15, 1402/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomised Clinical Trial on scalpel versus diathermy skin incision in maxillofacial surgery.
Public title
To determine which surgical tool is better for skin incisions in maxillofacial surgeries, whether it's scalpel or diathermy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 years old to 60 years old
Maxillofacial region surgery including tumor resection, neck dissection, parotid surgery, Maxillofacial trauma surgery
Incision length 2 cm to 10 cm
Patients who give consent
Exclusion criteria:
Patients who have active wound infections, anemia
Patients who are on corticosteroids, anticoagulant, anti platelet medication
Any previous scar or keloid
Patients with known connective tissue and skin disorders
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Method: Simple Randomization
Unit: Individual
Stratified randomization
Computer randomization using software
2 parallel groups (both would be intervention groups)
Allocation will be concealed from the patient and principal investigator (assessor) but not from the primary surgeon (Double Blind)
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will provide consent to be part of the trial. After which they would be randomized using computer software into two parallel intervention groups. Patients won't be aware of the group they belong to. They would be handed sealed envelope of their id number, only the surgeon and his/her operatiom theatre team would know the group to which the patient would belong to and they would record their findings against patients ID number without mentioning the group of the patient (whether scalpel group or diathermy group). The post surgery assessor and ward staff would also be blind to the randomization.
So, in short, Patients will be randomly assigned into two mutually exclusive groups each experiencing a different incision tool. The two groups will be scalpel group and diathermy group. Randomly, a sealed card with either scalpel or diathermy incision option inside, will be drawn, to decide which tool will be applied.
The surgeon performing the incision shall not be blinded, however the patient and the assessor will be blind to the incision tool used.
Placebo
Not used
Assignment
Parallel
Other design features
Sample size of 82 (with 41 participants in each group)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Committee, CMH Lahore Medical College and Institute of Dentistry
Street address
CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Pakistan
City
Lahore
Postal code
54810
Approval date
2024-01-12, 1402/10/22
Ethics committee reference number
.05/ERC/CMH/LMC12-01-24
Health conditions studied
1
Description of health condition studied
Incision time, intraoperative bleeding from Incision and post surgical pain after Incision using scalpel or diathermy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incision Time
Timepoint
Incision Time (time taken from the initial skin incision till end of incision), will be noted and calculated in seconds per unit wound area (sec/cm2).
Method of measurement
Stop watch
2
Description
Intraoperative blood loss
Timepoint
Intraoperative blood loss will be measured from the point when incision begins to the point patient is shifted out of the operation theater to the ward and eventually discharged from the ward. Every 6 hours after the surgery till the patient is discharged from the hospital (day 2 to day 6)
Method of measurement
Intraoperative blood loss will be measured by weighing the total weight of blood-soaked gauze from the patients
3
Description
Pain
Timepoint
Regular follow up with the patients will be carried out, every 6 hours post surgery on day 1 and day 2, daily for the next five days, at one week- for assessment of acute pain if any, 4 weeks, and 3 months- for assessment of chronic pain if any.
Method of measurement
Visual analogue scale for pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Scalpel Incision Group. No. 15 disposable scalpel with no.3 reusable sterilizable handles. Skin incisions, mucosal incisions would be larger than 2 cm in maxillofacial region. incisional time and intraoperative blood loss during incision shall be calculated during the surgery, for post-operative skin incision site pain, regular follow up with patients will be carried out over a period of three months to determine extent of postoperative pain. Prospective data will be collected in quantitative form. post-op visits (upto 3 months). Regular follow up with the patients will be carried out daily for five days, at one week- for assessment of acute pain if any, 4 weeks, and 3 months- for assessment of chronic pain if any.
Category
Treatment - Surgery
2
Description
Intervention group: Diathermy group. Incisions on skin and mucosal layers of maxillofacial region made using diathermy using Monopolar and Bipolar cautery at 0.5 to 3 MHz. incisional time and intraoperative blood loss during incision shall be calculated during the surgery, for post-operative skin incision site pain, regular follow up with patients will be carried out over a period of three months to determine extent of postoperative pain. Prospective data will be collected in quantitative form. post-op visits (upto 3 months). Regular follow up with the patients will be carried out daily for five days, at one week- for assessment of acute pain if any, 4 weeks, and 3 months- for assessment of chronic pain if any.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
CMH Lahore, CMH Lahore Medical College and Institute of Dentistry
Full name of responsible person
Dr. Vaffa Shahid Khan
Street address
Oral and Maxillofacial Surgery Department, CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Punjab, Pakistan
City
Lahore
Postal code
54810
Phone
+92 321 4481828
Email
vaffasaad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Lahore Medical College and Institute of Dentistry, Lahore, Pakistan
Full name of responsible person
Prof. Dr. Asad Aizaz Chatha
Street address
Head of Dept, Oral and Maxillofacial Surgery Department, CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Punjab, Pakistan
City
Lahore
Postal code
54810
Phone
+92 333 4205802
Email
asadchatha@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CMH Lahore Medical College and Institute of Dentistry, Lahore, Pakistan
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
CMH LAHORE MEDICAL COLLEGE AND INSTITUTE OF DENTISTRY
Full name of responsible person
Dr. Vaffa Shahid Khan
Position
Post Graduate Trainee/Resident of College of Physicians and Surgeons Pakistan
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial Surgery Department, CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Punjab, Pakistan
City
Lahore
Province
Punjab
Postal code
54810
Phone
+92 321 4481828
Email
vaffasaad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH LAHORE MEDICAL COLLEGE AND INSTITUTE OF DENTISTRY
Full name of responsible person
Dr. Vaffa Shahid Khan
Position
Post Graduate Trainee/Resident of College of Physicians and Surgeons Pakistan
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial Surgery Department, CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Punjab, Pakistan
City
Lahore
Province
Punjab
Postal code
54810
Phone
+92 321 4481828
Email
vaffasaad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
CMH LAHORE MEDICAL COLLEGE AND INSTITUTE OF DENTISTRY
Full name of responsible person
Dr. Vaffa Shahid Khan
Position
Post Graduate Trainee/Resident of College of Physicians and Surgeons Pakistan
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Oral and Maxillofacial Surgery Department, CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Punjab, Pakistan
City
Lahore
Province
Punjab
Postal code
54810
Phone
+92 321 4481828
Email
vaffasaad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
CMH Lahore doesn't allow sharing data of patients
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Randomised Clinical Trial on scalpel versus diathermy skin incision in maxillofacial surgery
When the data will become available and for how long
3 months after the publication
To whom data/document is available
Principal Investigator and sponsor
Under which criteria data/document could be used
Email to the principal investigator (me)
From where data/document is obtainable
Email to the principal investigator (me)
What processes are involved for a request to access data/document