COMPARATIVE STUDY OF DIFFERENT PROCEDURES FOR ELECTIVE LOWER ABDOMEN INCISIONS

Active, not recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/05/042793
• Lead Sponsor: DR REHANA BEGUM

Brief Summary

Patients fulfilling inclusion criteria who are willing to give written informed consent will be included in the study and will be randomly allocated using lottery method in one of the two groups. Patients will be counselled about the merits and demerits of both incisions and informed consent will be obtained for the study.

**Group 1 (Electro-cautery incision):**Incision will be taken using cutting current from an electrocautery device, set to pulse sine wave of 70 watts. Haemostasis will be achieved with forceps coagulation.

**Group 2 (Scalpel incision):**Skin incision will be taken with a conventional surgical blade mounted on a BP handle.

All the patients will be operated under spinal anaesthesia. All the patients undergoing clean procedure will receive 1gram cefotaxime intravenously, clean contaminated procedure will receive 1 gram of cefotaxime and metronidazole 500mg intravenously 30 mins prior to the commencement of procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-28
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Patients admitted under general surgery undergoing elective lower abdomen surgeries 2.
• Subjects Willing to provide the Informed Consent.

Exclusion Criteria

1. Emergency procedures 2) Recurrent surgeries.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Incision procedure assessment parameters (1. Incision time,2. Incisional blood loss,3. Post operative pain and use of analgesics,4. Wound infection rates,5. Cosmesis 6. Thermal injury)	Day 1, Day 2, Day 3, Day 10, Day 30

Secondary Outcome Measures

Name	Time	Method
Overall Safety	Day 1, Day 2, Day 3, Day 10, Day 30

Trial Locations

Locations (1)

BGS Global Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

BGS Global Institute of Medical Sciences

🇮🇳Bangalore, KARNATAKA, India

Dr Rehana Begum

Principal investigator

9052752646

rehanarayan07@gmail.com