A prospective randomized trial of Kotase® (Bromelain + Trypsin) in the management of post-operative abdominal wounds at the University of Nigeria Teaching Hospital Enugu, Nigeria

Abstract

Background : Kotase ® is a combination systemic enzyme therapy that contains bromelain and trypsin. Bromelain is a crude extract of pineapple plant that contains mainly plant proteases. A multitude of actions have been ascribed to it including anti inflammatory properties. Aim : To evaluate the efficacy of bromelain/trypsin combination (Kotase ® ) in resolution of post laparotomy wound inflammation. Materials and Methods : The study is an open labeled study in which 111 patients were randomized in a 1:1 ratio to receive either Kotase ® or no kotase in their post op treatment. All the patients had major laparotomy wounds and were able to resume oral intake within 72 hours of surgery. The two groups of patients received all treatment necessary for their condition except with regards to analgesic and anti-inflammatory treatment. After commencement of oral intake, patients for Kotase treatment had two tablet of Kotase ® qid added to their post op drugs for a maximum of ten days or until the patient was discharged. Patients were assessed every day for operative wound pain, and inflammatory oedema. Also, the analgesic requirements and wound failure rates were assessed. Results : The two groups were matched with respect to demographic characteristics and case distribution. In the no treatment arm, the average post op inflammatory oedema decreased from 1.969mm on commencement of oral intake to 1.827mm on the 5 th day of measurement and 1.631mm by the time the patients were discharged. In the Kotase ® treatment group, the inflammatory oedema decreased from 1.959mm on the first day of drug treatment to 1.389mm by the 5 th day and 1.018mm by the time the patients were discharged. There was significant difference in the size of the oedema of the two groups on the 5 th day and by the time of discharge. The average visual analogue pain score of patients without Kotase ® decreased from 6.27 on the first day of oral intake to 3.65 by the 5 th day and 1.84 by the time the patients were discharged. The patients that had Kotase ® had an average pain score of 6.32 on the 1 st day and 2.45 on the 5 th day and 0.68 by the time of discharge. Again the drop in pain score was significantly more in the patients that had Kotase ® . Ten patients in the no Kotase ® arm needed extra doses of dipyrone in addition to the set down analgesics to control their pain while only one in the Kotase ® arm needed extra doses of analgesics to control his pain. There were 6 minor wound infections in each treatment arm and one wound breakdown in the no Kotase ® treatment group. There was no unexpected adverse reaction due to the use of Kotase ® . Conclusion : The results show the effectiveness of combination of bromelain and trypsin in reducing post operative inflammatory oedema and operation wound pain that accompany major laparotomy wounds. Keywords : bromelain, trypsin, post op inflammation, systemic enzyme therapy (SET) Journal of College of Medicine Vol. 10(2) 2005: 61-66