Actively Recruiting
Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial
Led by Dr Hamail Khanum · Updated on 2025-05-06
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Negative Pressure Wound Therapy (NPWT) to prevent infections in patients undergoing laparotomy surgery. This randomized clinical trial will compare the effects of NPWT combined with standard antibiotic treatment against standard antibiotics alone in patients aged 20 to 70 years. The study aims to determine if applying NPWT at the end of surgery reduces surgical site infections and the need for further operations. Participants will be randomly assigned to one of two groups. Group A will receive Negative Pressure Wound Therapy applied immediately after laparotomy, followed by a 72-hour stay in the post-surgical ward and a course of standard antibiotics. Group B will receive standard antibiotics without NPWT but undergo the same post-surgical care and follow-up. Both groups will be monitored for 30 days after discharge to assess surgical site infections and any need for re-operation. During the study, participants will be closely observed in the hospital for the first 72 hours post-surgery and then followed regularly in outpatient visits for 30 days. Researchers will document any surgical site infections and whether additional surgery is needed. All complications will be treated according to hospital protocols. The main outcome measured is the occurrence of surgical site infections within three months, with secondary assessment of re-operations during the same period.
CONDITIONS
Brief Title
Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 20 to 70 years, any gender
- Undergoing laparotomy under general anaesthesia
- Classified as ASA physical status I or II
You will not qualify if you...
- Patients who do not complete follow-up instructions
- Pregnant patients
- Patients who have had a relook laparotomy with an open abdomen or cannot adhere to study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 days
Participants undergo laparotomy surgery and receive either Negative Pressure Wound Therapy or standard antibiotic treatment. They stay in the post-surgical ward for 72 hours after surgery.
1 hospital stay (in-person)
Duration - 30 days
Participants are followed up in the outpatient department for 30 days to assess surgical site infection and the need for re-operation.
Outpatient visits during 30-day follow-up
Trial Site Locations
Total: 1 location
1
Gulab Devi Hospital Lahore
Lahore, Punjab Province, Pakistan, 05307
Actively Recruiting
Research Team
D
Dr Hamail Khanum, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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