| CTRI Number |
CTRI/2022/05/042624 [Registered on: 18/05/2022] Trial Registered Prospectively |
| Last Modified On: |
14/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
research to compare the outcomes of using knife versus heat cutting during cutting skin in abdominal surgery |
|
Scientific Title of Study
|
Study of surgical outcome of skin incision by scalpel versus diathermy in elective abdominal procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Kumar Roy |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of General Surgery, IGIMS, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
9801716613 |
| Fax |
|
| Email |
roykanu23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Kumar Roy |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of General Surgery, IGIMS, Sheikhpura, Patna
BIHAR
800014
India |
| Phone |
9801716613 |
| Fax |
|
| Email |
roykanu23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Kumar Roy |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of General Surgery, IGIMS, Sheikhpura, Patna
BIHAR
800014
India |
| Phone |
9801716613 |
| Fax |
|
| Email |
roykanu23@gmail.com |
|
|
Source of Monetary or Material Support
|
| IGIMS, Sheikhpura, Patna, Bihar 800014 |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Kumar Roy |
| Address |
Department of General Surgery, IGIMS, Sheikhpura, Patna, Bihar 800014 |
| Type of Sponsor |
Other [Self (Investigator) Funded] |
|
|
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 Vivek Kumar roy |
Indira Gandhi Institute of Medical Sciences (IGIMS) |
Department of General Surgery, IGIMS, Sheikhpura, Patna, Bihar 800014
Patna
BIHAR |
9801716613
roykanu23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z533||Procedure converted to open procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
incision by scalpel |
Scalpel is an essential dermatological tool used for making skin incisions, tissue dissections, and a variety of surgical approaches since the onset of modern surgery. Scalpel blades come in different sizes, identified by a blade number, and each serving a different purpose.
The intervention is applied during the surgical procedure. |
| Intervention |
Skin incision by diathermy |
Diathermy is the controlled production of "deep heating" beneath the skin in the subcutaneous tissues, deep muscles and joints for therapeutic purposes. Incision made by diathermy is quick, reduces bleeding, and causes less postoperative pain, but produces a burn of variable depth in the tissue, which may affect outcome of surgical wound.
The intervention is applied during the surgical procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
all patients admitted in the surgery department for elective abdominal surgical procedures |
|
| ExclusionCriteria |
| Details |
1. Age <18 years
2. Any malignant disease.
3. Chronic medical illness like diabetes, asthma , tuberculosis.
4. Gross infection of operative site.
5. Unwilling patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound healing as assessed by Southampton grading system |
on day 7 after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain at surgical site |
day 0, day 1 and day 2 after surgery |
| late wound complications |
2nd, 4th, 6th week and 6 months after operation |
|
|
Target Sample Size
|
Total Sample Size="364"
Sample Size from India="364"
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)
|
23/05/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aims and Objectives- To compare the incision time , blood loss during incision, post operative pain, wound healing and wound complications using diathermy versus scalpel for skin incision.
Methodology- Inclusion criteria- all patients admitted in the surgery department for elective abdominal surgical procedures. Exclusion criteria- Age <18 years Any malignant disease. Chronic medical illness like diabetes, asthma , tuberculosis. Gross infection of operative site. Unwilling patients
Method Patient admitted for elective abdominal surgery fulfilling the inclusion and exclusion criteria. Informed consent. Complete medical history, physical examination and routine laboratory tests. A prophylactic dose of one gram of ceftriaxone one hour prior to the incision. The abdominal skin preparation with povidone iodine in the operating room. Document- Incision time, incision length was measured using and blood loss during incision Patients evaluation clinically for pain daily during postoperative period on day 0, day 1 and day 2 using the visual analogue scale which was represented by a straight line measuring 10 divisions, the extremes of which corresponded to no pain at one end and worst pain at the other end. Wound healing will be assessed on day 7 of operation using the Southampton grading system which denote the presence or absence of an infection. G0: normal wound healing, G1: normal healing with mild bruising or erythema, G2: erythema plus other signs of inflammation, G3: clear or serosanguinous discharge, and G4: purulent discharge. Manchester scar scale will be used for assessing wound scar (scar is formed physiologically end of one month), which includes colour, matte or shiny, contour, distortion and texture. All patients will be followed up in 2nd, 4th, 6th week and 6 months after the discharge and any readmission after discharge from the hospital will evaluated to detect the occurrence of late wound complications. Analysis- Using appropriate statical tools • Incision time • Blood loss • Post-operative pain- association between scalpel and cautery (chi square test) • Wound scar- association between scapel and cautery (chi square test) • Wound infection- association between scalpel and cautery (chi square test). • Wound scaring |