| CTRI Number |
CTRI/2024/10/074609 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| 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
|
Comparison of scalpel and electrocautery usage for incision in abdominal surgeries |
|
Scientific Title of Study
|
To Assess the Outcome of Scalpel Incision and Electrocautery Incision in Abdominal Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashna Nagpal |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department Of General Surgery, AVBRH Hospital,Jawaharlal Nehru Medical College,DMIHER, Sawangi, Wardha
Jawaharlal Nehru Medical College, Sawangi, Wardha
Wardha
MAHARASHTRA
442004
India |
| Phone |
8825055095 |
| Fax |
|
| Email |
anagpal770@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PANKAJ GHARDE |
| Designation |
PROFESSOR, DEPARTMENT OF GENERAL SURGERY |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF GENERAL SURGERY, AVBRH HOSPITAL,JAWAHARLAL NEHRU MEDICAL COLLEGE, DMIHER, SAWANGI, WARDHA
JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI, WARDHA
Wardha
MAHARASHTRA
442004
India |
| Phone |
9372717775 |
| Fax |
|
| Email |
pankaj_nandini75@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PANKAJ GHARDE |
| Designation |
PROFESSOR, DEPARTMENT OF GENERAL SURGERY |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF GENERAL SURGERY, AVBRH HOSPITAL,JAWAHARLAL NEHRU MEDICAL COLLEGE, DMIHER, SAWANGI, WARDHA
JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI, WARDHA
Wardha
MAHARASHTRA
442004
India |
| Phone |
9372717775 |
| Fax |
|
| Email |
pankaj_nandini75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, SAWANGI, WARDHA, MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
ASHNA NAGPAL |
| Address |
DEPARTMENT OF GENERAL SURGERY, JAWAHARLAL NEHRU MEDICAL COLLEGE, DMIHER, WARDHA, SAWANGI, MAHARASHTRA 442004 |
| Type of Sponsor |
Other [SELF] |
|
|
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 ASHNA NAGPAL |
ACHARYA VINOBA BHAVE RURAL HOSPITAL, DMIHER, WARDHA, SAWANGI, MAHARASHTRA |
DEPARTMENT OF GENERAL SURGERY, AVBRH HOSPITAL, JAWAHARLAL NEHRU MEDICAL COLLEGE, DMIHER, SAWANGI, WARDHA, MAHARASHTRA
Wardha
MAHARASHTRA |
8825055095
anagpal770@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients willing to give consent for the research.
2 Patients posted for surgeries with incision within 10cm in length.
3 All the males and females posted for routine and emergency surgeries.
4 Patients between the age of 18 to 60 years. |
|
| ExclusionCriteria |
| Details |
1.Patients with previous midline laparotomy.
2• Concurrent anticoagulant.
3• Corticosteroid therapy.
4• Factors that could affect wound healing like anemia and hypoproteinemia.
5• Patients with comorbodities
6• Patients with active wound infections anywhere in the body at the time of surgery
were excluded from the study.
7• Patients with high BMI
8• Patients with Psychiatric illness |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood loss during the incison shall be calculted. Wound related pain . Wound infections. presence of erythema, induration and pain. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical assessment of the wound shall be done on POD 3,5 & 7 for surgical site
infection till the patient is discharged & on the first follow-up visit to hospital.
Wound infections shall be considered.
Grade 1 in the presence of erythema, induration & pain.
Grade 2 same findings as grade 1 & with serous fluid.
Grade 3 in the presence of contaminated fluid in less than half wound.
Grade 4 same as grade 3 in more than half wound |
7 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
02/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
THE STUDY WILL BE CONDUCTED AT A TERTIARY CARE HOSPITAL AND TEACHING HOSPITAL IN CENTRAL INDIA ON PATIENTS ADMITTED FOR EMERGENCY AND ELECTIVE SURGICAL PROCEDURES. THE STUDY WILL BE CONDUCTED WITH THE APPROVAL OF THE ETHICS COMMITTEE.
TO STUDY THE OUTCOME OF SCALPEL AND CAUTERY INCISIONS IN ABDOMINAL SURGERIES
THE STUDY WILL BE CONDUCTED FOR A 2 YEAR PERIOD
THE STUDY WILL FOCUS ON FOLLOWING OBJECTIVES : 1. EVALUATION OF TISSUE NECROSIS AND WOUND DEHISCENCE IN INCISION GROUP 2. EVALUATION OF TISSUE NECROSIS AND WOUND DEHISCENCE IN ELECTROCAUTERY GROUP 3. TP EVALUATE THE SURGICAL SITE INFECTION 4. TO EVALUATE PAIN AND INFECTION IN BOTH THE GROUPS
|