| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
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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
|