Safety and Effectiveness of a Fixed-Dose Combination of Trypsin, Bromelain, and Rutoside in Wound Management: A Randomized Clinical Trial.

Background Wound healing following tissue injury is a precisely programmed biological process, typically occurring in a proper sequence and timeframe. While healing is perceived as inevitable, it heavily depends on tissue perfusion, which ensures oxygen and nutrient delivery, removal of waste, and promotion of cellular repair mechanisms. However, complications such as vascular occlusion due to fibrin or cellular debris, microbial contamination leading to infection, ischemic tissue necrosis, and dysregulated inflammation can impair healing. Proper care and repair are crucial to maintaining tissue perfusion and supporting the normal wound healing phases: reaction, regeneration, and remodeling. The use of oral enzymatic agents like trypsin, bromelain, and rutin offers a faster and more reliable method to support wound healing by reducing inflammation and enhancing tissue regeneration. This study was designed to assess the safety and effectiveness of treatment with Tibrolin (a fixed-dose combination of trypsin 48 mg, bromelain 90 mg, and rutoside 100 mg tablet) in improving wound healing and alleviating acute pain in patients following uncontaminated surgeries. Methods A phase-IV, open-label, prospective, multi-center clinical study was conducted on 200 patients after elective, clean, uncontaminated surgery. Patients were randomized (1:1) to receive either Tibrolin or Chymoral Forte (trypsin-chymotrypsin) tablets, administered as two tablets to be taken orally thrice a day for seven days postoperatively. The primary outcome measure was the percentage of patients reporting incidences of adverse events, while secondary outcome measures were the mean change in the individual and total score of surgical wounds and the Numerical Pain Rating Scale (NPRS) score from baseline (day 0) to day 7. Results Tibrolin was well-tolerated in the study, with no observed adverse or treatment-related adverse events. At the end of the treatment regimen, all wound healing parameters, including erythema, edema, discharge, induration, local irritation, and tenderness, showed a highly significant improvement (p < 0.001) in both treatment groups. Additionally, there was more than an 85% reduction in NPRS scores reported in both groups. A non-significant difference between groups in pain reduction (p = 0.737) and wound healing symptoms (p = 0.554) confirms that Tibrolin is as efficacious as trypsin-chymotrypsin when evaluated on days 3, 5, and 7 of treatment. Tibrolin tablets were regarded as good to excellent for treating wound symptoms by 87% of patients and 94% of investigators. Conclusion Our results suggest that Tibrolin administration favors wound healing and improves wound symptoms, such as edema, inflammation, and pain in the management of elective clean, uncontaminated surgical wounds.