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IRCT20240101060587N1 IRCT 2024-01-28 CMH Lahore Medical College and Institute of Dentistry, Lahore, Pakistan To determine which surgical tool is better for skin incisions in maxillofacial surgeries, whether it's scalpel or diathermy Not applicable Randomised Clinical Trial on scalpel versus diathermy skin incision in maxillofacial surgery. 2024-01-15 anticipated 82 Complete https://irct.ir/trial/74755 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Sample size of 82 (with 41 participants in each group), 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 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. N/A Incision time, intraoperative bleeding from Incision and post surgical pain after Incision using scalpel or diathermy. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is CMH Lahore doesn't allow sharing data of patients
public Dr. Vaffa Shahid Khan
Oral and Maxillofacial Surgery Department, CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Punjab, Pakistan
Lahore Pakistan 54810 +92 321 4481828 vaffasaad@gmail.com CMH LAHORE MEDICAL COLLEGE AND INSTITUTE OF DENTISTRY scientific Dr. Vaffa Shahid Khan
Oral and Maxillofacial Surgery Department, CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Punjab, Pakistan
Lahore Pakistan 54810 +92 321 4481828 vaffasaad@gmail.com CMH LAHORE MEDICAL COLLEGE AND INSTITUTE OF DENTISTRY Pakistan 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 30 years 60 years Both 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 Treatment - Surgery Treatment - Surgery 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. 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. 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. 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. 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. CMH Lahore Medical College and Institute of Dentistry, Lahore, Pakistan Approved 2024-01-12 Ethical Review Committee, CMH Lahore Medical College and Institute of Dentistry CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Pakistan Lahore Punjab Pakistan