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CTRI Number  CTRI/2025/01/079098 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To know the appearance of postoperative scars following the use of electrocautery versus scalpel in elective mid line abdominal skin incisions 
Scientific Title of Study   Comparison of the appearance of postoperative scars following the use of electrocautery versus scalpel in elective mid line abdominal skin incisions a randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Toufiq Hassan K 
Designation  junior resident 
Affiliation  all india institute of medical sciences patna  
Address  department of general surgery all india institute of medical sciences patna aurangabad road phulwari sharif patna bari khagaul bihar 801507

Patna
BIHAR
801507
India 
Phone  9444126747  
Fax    
Email  toufiqqqq2222@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Toufiq Hassan K 
Designation  junior resident 
Affiliation  all india institute of medical sciences patna  
Address  department of general surgery all india institute of medical sciences patna aurangabad road phulwari sharif patna bari khagaul bihar 801507

Tirunelveli
BIHAR
801507
India 
Phone  9444126747  
Fax    
Email  toufiqqqq2222@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashesh Kumar Jha 
Designation  additional professor 
Affiliation  all india institute of medical sciences patna 
Address  department of general surgery opd aiims patna bihar 801507

Patna
BIHAR
801507
India 
Phone  9582199341  
Fax    
Email  drasheshjha@aiimspatna.org  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  All India Institute of Medical Sciences Patna Aurangabad road Phulwari Sharif Patna Bari Khagaul Bihar 801507 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr toufiq hassan k  All India Institute of Medical Sciences Patna  Department of General Surgery Third floor Aurangabad road Phulwari Sharif Patna Bari Khagaul Bihar 801507
Patna
BIHAR 
9444126747

toufiqqqq2222@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee AIIMS Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Electrocautery  In Group A patients will receive skin incisions using a 35 W electrocautery in cut mode Erbe VIO 300 S which will also be used for incising the subcutaneous tissue and linea alba Haemostasis will be achieved as necessary using the coagulation mode of the device Key intraoperative parameters such as incision time measured in seconds wound dimensions length and depth to calculate area in cm² and blood loss determined by gauze weight difference and reported per unit area will be systematically documented Patients will receive preoperative prophylactic antibiotics and postoperative pain management will involve diclofenac with additional analgesics provided if needed Pain will be monitored daily using a Visual Analogue Scale from postoperative day 1 to day 5 Follow up assessments will include surgical site infection evaluations on day 30 following CDC guidelines and scar quality assessments at four months using the Vancouver Scar Scale and Patient and Observer Scar Assessment Scale  
Comparator Agent  Scalpel  In Group B patients will receive skin incisions using a scalpel and 35 W electrocautery Erbe VIO 300 S used for incising the subcutaneous tissue and linea alba Haemostasis will be achieved as necessary using the coagulation mode of the device Key intraoperative parameters such as incision time measured in seconds wound dimensions length and depth to calculate area in cm² and blood loss determined by gauze weight difference and reported per unit area will be systematically documented Patients will receive preoperative prophylactic antibiotics and postoperative pain management will involve diclofenac with additional analgesics provided if needed Pain will be monitored daily using a Visual Analogue Scale from postoperative day 1 to day 5 Follow up assessments will include surgical site infection evaluations on day 30 following CDC guidelines and scar quality assessments at four months using the Vancouver Scar Scale and Patient and Observer Scar Assessment Scale  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age group 18 to 70 years
Willing to participate
Incision length 5 to 10 cm
ASA class I and II
Clean or clean contaminated surgical wounds as classified by the American College of Surgeons Committee on Control of Surgical Infections
 
 
ExclusionCriteria 
Details  Patients with a preexisting scar at the planned surgical incision site
Patient who has a known predilection for hypertrophic or keloid scars
Known case of connective tissue disorders
BMI greater than 30
On immunosuppressive therapy
History of chemotherapy within the last 2 weeks before surgery and or radiotherapy of the abdomen within last 8 weeks before surgery
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the post operative wound scar appearance following the use of electrocautery versus scalpel in mid line abdominal skin incision based on a structured and validated Vancouver scar scale scoring system  4 months 
 
Secondary Outcome  
Outcome  TimePoints 
To measure and compare the mean incision time per unit wound area in seconds per square centimeter following the use of electrocautery versus scalpel in mid line abdominal skin incision  intra operative period 
To measure and compare the blood loss during incision time following the use of electrocautery as opposed to scalpel in mid line abdominal skin incision by utilizing weighing in gram mes the sterile gauze pieces before and after the usage of electrocautery versus scalpel  intraoperative period 
To score the postoperative pain utilizing the Visual Analogue Scale on postoperative days 1 to 5  postoperative days 1 to 5 
To assess and compare the 30 day postoperative wound infection rates using the CDC guidelines for Surgical Site Infections following the use of electrocautery versus scalpel in mid line abdominal skin incision  1 month 
To compare the postoperative wound scar appearance both subjectively and objectively following the use of electrocautery versus scalpel in mid line abdominal skin incision based on a structured and validated The Patient and Observer Scar Assessment Scale  4 months 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study targets patients scheduled for elective midline abdominal incisions ranging from 5 to 10 cm in length who meet the specified inclusion criteria and voluntarily provide informed consent For cases where the incision length exceeds 10 cm data will still be included in the intention to treat  analysis but such cases will be excluded from the per protocol analysis Prior to the procedure all patients will undergo thorough health assessments to evaluate their fitness for surgery They will also receive detailed information about the two incision methods including the associated benefits and risks  ensuring they can make an informed decision Once consent is obtained each patients demographic and clinical details will be recorded in a pre designed data collection form

To ensure randomization patients will be allocated to one of two groups using sealed envelopes opened only after the induction of anesthesia by a non-study staff member to maintain blinding Participants in Group A will have their skin incision performed using a 35 W electrocautery device in cut mode Erbe VIO 300 S 2018 while those in Group B will have their incision made with a scalpel For both groups the subcutaneous tissue and linea alba will be incised using electrocautery in cutting mode with coagulation mode employed as needed for haemostasis  All patients will receive standardized preoperative antibiotics to minimize infection risk  and skin closure will be carried out uniformly using 3 0 nylon sutures

Blinding measures are integral to the study design Both the patients and the follow up surgeon will remain unaware of the incision method used The follow up surgeon who is independent of the surgical team will be responsible for assessing outcomes to eliminate bias The study will evaluate several key parameters including intra operative metrics like incision time and blood loss per unit wound area Postoperative outcomes will focus on pain levels measured daily using the Visual Analogue Scale  from day 1 to day 5 and surgical site infection rates assessed on the 30th postoperative day in accordance with CDC guidelines If required wound cultures will be performed to identify any infectious agents At four months scar quality will be examined using two standardized tools the Vancouver Scar Scale  for physical appearance and the Patient and Observer Scar Assessment Scale  for comprehensive quality assessment

Follow up visits are scheduled for day 30 and four months post-surgery For patients discharged earlier remote evaluations will be conducted via photographs or teleconsultations with in person visits arranged for cases requiring closer examination At the four month follow up scars will be thoroughly assessed during an outpatient appointment by the blinded follow up surgeon

 
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