Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Surgical Site Infection
Study Overview
Brief Summary
Total 70 participants meeting selection criteria will be enrolled in the study from operational theatre. They will be randomly divided in two groups by using lottery method. In group A, Negative Pressure Wound Therapy will be applied at end of procedure. In group B, no Negative Pressure Wound Therapy will be placed. They will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics and will be followed-up in OPD for 30 days. If patient will develop surgical site wound infection, then it will be noted. If infection will not be cured with antibiotics course, then re-operation will be done. Patients complications will be managed as per hospital protocol. All this information will be recorded in proforma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of age between 20 to 70 years, both genders
- •Undergoing laparotomy under general anaesthesia
Exclusion Criteria
- •Patients who did not complete the follow up instructions
- •Pregnant patients
- •Patients already undergone a relook laparotomy, if their abdomen is left open or if unable to adhere
Arms & Interventions
Participants with Negative Pressure Wound Therapy
In group A, Negative Pressure Wound Therapy will be applied at end of laparotomy. Participants will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics course. Patients will be followed-up in OPD for 30 days and will be assessed in terms of surgical site infection and re operation.
Intervention: Negative Pressure Wound Therapy (Other)
Participants with Negative Pressure Wound Therapy
In group A, Negative Pressure Wound Therapy will be applied at end of laparotomy. Participants will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics course. Patients will be followed-up in OPD for 30 days and will be assessed in terms of surgical site infection and re operation.
Intervention: Standard Antibiotic Treatment (Drug)
Participants without Negative Pressure Wound Therapy
In group B, Negative Pressure Wound Therapy will be applied at end of laparotomy. Participants will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics course. Patients will be followed-up in OPD for 30 days and will be assessed in terms of surgical site infection and re operation.
Intervention: Standard Antibiotic Treatment (Drug)
Outcomes
Primary Outcomes
Surgical Site Infection
Time Frame: 03 Months
It will be labelled if there will be presence of pus and pus discharge from wound site, confirmation of presence of pathogen through culture along with presence of pain, swelling, tenderness at wound site on physical examination during 15-30 days of surgery.
Secondary Outcomes
- Re Operation(03 Months)
Investigators
Dr Hamail Khanum
Head of Department Surgery
Gulab Devi Hospital