Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorDr Hamail Khanum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of age between 20 to 70 years, both genders
Undergoing laparotomy under general anaesthesia
ASA I-II
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Negative Pressure Wound Therapy
Other interventionNegative Pressure Wound Therapy is an intervention in which a suction is applied at applied thus creating a negative pressure which not only removes any exudate but also aids in formation of granulation tissue. NPWT is provided along with empirical prophylactic antibiotics
Standard Antibiotic Treatment
DrugAccording to hospital antibiogram, empirical antibiotics are given prophylactically
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Participants with Negative Pressure Wound TherapyExperimental treatment 2 interventions
Group B: Participants without Negative Pressure Wound TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Surgical Site Infection
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.
Time frame
03 MonthsSecondary outcomes
1
Re Operation
It will be labelled if patient will undergo surgery due to severe surgical site wound infection that develop during 15-30 days of surgery and not healed with antibiotics course.
Time frame
03 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr Hamail Khanum
Lead sponsor
Gulab Devi Hospital
Sponsor institution
Source ClinicalTrials.gov