research to compare the outcomes of using knife versus heat cutting during cutting skin in abdominal surgery
- Conditions
- Procedure converted to open procedure,
- Registration Number
- CTRI/2022/05/042624
- Lead Sponsor
- Dr Vivek Kumar Roy
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 364
all patients admitted in the surgery department for elective abdominal surgical procedures.
- Age <18 years 2.
- Any malignant disease.
- Chronic medical illness like diabetes, asthma , tuberculosis.
- Gross infection of operative site.
- Unwilling patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound healing as assessed by Southampton grading system on day 7 after surgery
- Secondary Outcome Measures
Name Time Method late wound complications 2nd, 4th, 6th week and 6 months after operation Pain at surgical site day 0, day 1 and day 2 after surgery
Trial Locations
- Locations (1)
Indira Gandhi Institute of Medical Sciences (IGIMS)
🇮🇳Patna, BIHAR, India
Indira Gandhi Institute of Medical Sciences (IGIMS)🇮🇳Patna, BIHAR, IndiaDr Vivek Kumar royPrincipal investigator9801716613roykanu23@gmail.com