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
Qualifiers
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
Treatments tested in this trial
- Negative Pressure Wound Therapy
- Standard Antibiotic Treatment
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dr Hamail Khanum
Lead sponsor
Gulab Devi Hospital
Sponsor institution
Source ClinicalTrials.gov