Hypericum and neem oil for dehisced post-surgical wounds: a randomised, controlled, single-blinded phase Ill study
Arena et al. Journal of Wound Care, vol 31, No 6, June 2022
Objective: To evaluate the clinical efficacy of a hypericum and neem oil dressing, Primary Wound Dressing (ONE) (1PWD) (WOUND) (Kerecis AG, Switzerland), in a patient population with dehiscence of surgical wounds with critical colonisation / infection.
Method: a randomised, controlled, single-blinded, parallel arms phase III study was conducted comparing the experimental medication (WOUND) to silver based dressings (silver-based polyurethane foam or alginate dressings). All patients were evaluated at enrolment, on days 7, 14, 21 and 28. Improvement of inflammatory / infective symptoms was measured by detecting seven items of the Bates-Jensen Wound Assessment Tool (BWAT). Pain was assessed using the Numeric Rating Scale (NRS).
Results: The study enrolled 99 patients. Follow-up was completed in 49 patients in the experimental group (WOUND) and 48 patients in the control group (Silver-based dressings). Overall BWAT evaluation demonstrated similar outcomes between the groups; t=0.23, p-value=0.81, 95% confidence interval (CI): -13.3-10.8. Furthermore, when evaluating the seven items of the BWAT relating to inflammatory signs, there was not a significant difference between the groups: t=0.38, p=0.35, 95% CI: -2.8-2.7. However, when an analysis using the NRS pain scale was performed a statistically significant pain reduction was demonstrated in favor of the experimental group
(WOUND): t=7.8, p<0.0001, 95% CI: 2.918-4.8819.
Conclusion: This randomised controlled trial confirmed the efficacy of 1PWD (WOUND), an investigational product, in the management of surgical dehiscence with critical colonisation or infection, with the added benefit of significant pain reduction when compared with a silver-based dressing (silver-based polyurethane foam or alginate dressings).
Additional Information from the article
It is specifically mentioned in the article on page 499: that this study showed that the use of 1PWD (WOUND) was non-inferior in the treatment of critical colonisation / infection and contributed to significant pain reduction as compared with silver based-dressings. This confirmed data from observational studies on the anti-inflammatory activity of this formulation, comprising neem and hypericum oils.
