WINVIVO Wound Ointment in the Treatment of Difficult-to-Heal Wounds
The following clinical study is published in the journal of
"Advances in Skin & Wound Care" December 2012 - Volume 25 - Issue 12 - p 557-560
Here are some excerpts of this paper:
Authors: Alexander M. Reyzelman, DPM (Co-Director of UCSF's Center for Limb Preservation & Associate Professor at California School of Podiatric Medicine at Samuel Merritt University) & Irina Bazarov, MS (California School of Podiatric Medicine at Samuel Merritt University)
Abstract: Chronic wounds are characterized by prolonged inflammation, bacterial bioburden, and ischemia. These factors represent the barriers to wound healing that need to be addressed in order to achieve wound closure. The authors performed the initial clinical testing of WinVivo Wound Ointment (“WinVivo”), a novel topical ointment containing several botanicals that have been previously shown to promote favorable wound environment and advance wound healing. In this series of 13 patients with difficult-to-heal lower-extremity wounds, WinVivo was well tolerated and demonstrated the ability to simultaneously support granulation tissue formation; decrease the amount of exudate, edema, and malodor; and reduce pain. The ulcers included in this study have been present for a minimum of 3 weeks and a maximum of 5 years prior to the start of treatment with WinVivo. Eight of 13 wounds have previously been treated with at least 1 type of advanced wound healing modality, such as dermal substitutes or negative-pressure wound therapy. Treatment with WinVivo lasted for 3 to 12 weeks and resulted in a mean 88% wound closure, with 4 wounds healing completely. In addition to significant reduction in wound size, all patients have exhibited other clinical benefits, suggesting overall improvement in wound conditions. Future studies in a larger population, as well as case-control studies comparing WinVivo with a standard of care, are therefore warranted to further evaluate the efficacy of this new treatment.
Figure 1: Wound closure in patients treated with WINVIVO
Figure 3: Wound conditions change during WINVIVO treatment
Table 1: Characteristics of difficult-to-heal lower extremity wounds treated with WINVIVO
Discussion: Majority of chronic wounds share four common characteristics: excessive inflammation, hypoxia, ongoing oxidative damage and bacterial bioburden2‐4. In vivo studies of wound models demonstrate the roles that these factors play in delaying wound closure, and suggest that the reversal of these factors dramatically improves healing of chronic wounds4. To the authors’ knowledge, few, if any, currently available treatment modalities offer the multifunctional benefits of anti‐inflammatory, anti‐oxidative, antibacterial and analgesic properties simultaneously. Owning to its unique composition, WinVivo helps the wounds overcome several barriers to healing, apparently without triggering adverse reactions. WinVivo appeared to lower inflammation and bacterial contamination of the wound site, as evidenced by decreased amount of exudate, periulcer erythema, biofilm and malodor. Increase in granulation tissue formation and epithelialization following WinVivo treatment suggests that this ointment restores healthy wound microenvironment, which is necessary for successful wound closure. While the small patient population size and short duration of the study prevent the authors from drawing any conclusions about the product’s efficacy in treating difficult‐to‐heal lower extremity wounds, it has been nevertheless observed that WinVivo is well tolerated and easy to use in the clinical setting. Future studies in larger populations with longer follow‐up periods are necessary to establish the product’s effectiveness in treating chronic non‐healing wounds.