PhytoCare®

…PC (PhytoCare Swine Skin Recovery & Care®; Precision Health Technologies, Brookings, SD, USA): Male piglets (n = 31) surgically castrated with topical application of PhytoCare Swine Skin Recovery & Care® at the incision site post…

…PC (PhytoCare Swine Skin Recovery & Care®; Precision Health Technologies, Brookings, SD, USA): Male piglets (n = 31) surgically castrated with topical application of PhytoCare Swine Skin Recovery & Care® at the incision site post…

ry safety and efficacy field trials with the principles of Good Clinical Practice (GCP) as laid down in the Council Directive 2001/82/EC and guideline CVMP/VICH/595/98 VICH Topic GL9 Step 7-Guideline on Good Clinical Practices (CVMP approved July 2000). The animal study was performed, with owner consent, at two commercial pig farms in Germany and Italy dedicated to the management of breeding sows. Together, 173 commercially bred male piglets (Danish and Landrace ×Large White) between 3 and 7 days of age and in good health were confirmed suitable for enrolment in the study. Prior power analysis indicated the requirement for a minimum of 80 animals per group to show a significant reduction at the 5% level. Litters with 6–12 male piglets (7 average) were selected for the study at each site. Piglets within a litter were individually identified by ear tag (applied on study Day −2) and spray/pen mark. Piglets within a litter were randomly allocated to treatment or control groups. All study piglets had standard blue spray-on piglet marker dye applied to the scrotum prior to procedures, to blind post-operative observers to any translucent-blue colouring that may have remained following application of treatment. This method of blinding was used rather than a placebo solution, to allow comparison with standard castration practice, and prevent confounding due to potential impacts (pain/inflammation/infection) from wound instillation of a placebo solution. Hence, the person performing the treatment was unblinded, however, this person did not participate in any trial assessments or data analysis. Study animals were maintained in their normal farrowing pens as per standard farm practice with their dam and litter mates. Piglets had ad lib access to potable water and con- stant

ry safety and efficacy field trials with the principles of Good Clinical Practice (GCP) as laid down in the Council Directive 2001/82/EC and guideline CVMP/VICH/595/98 VICH Topic GL9 Step 7-Guideline on Good Clinical Practices (CVMP approved July 2000). The animal study was performed, with owner consent, at two commercial pig farms in Germany and Italy dedicated to the management of breeding sows. Together, 173 commercially bred male piglets (Danish and Landrace ×Large White) between 3 and 7 days of age and in good health were confirmed suitable for enrolment in the study. Prior power analysis indicated the requirement for a minimum of 80 animals per group to show a significant reduction at the 5% level. Litters with 6–12 male piglets (7 average) were selected for the study at each site. Piglets within a litter were individually identified by ear tag (applied on study Day −2) and spray/pen mark. Piglets within a litter were randomly allocated to treatment or control groups. All study piglets had standard blue spray-on piglet marker dye applied to the scrotum prior to procedures, to blind post-operative observers to any translucent-blue colouring that may have remained following application of treatment. This method of blinding was used rather than a placebo solution, to allow comparison with standard castration practice, and prevent confounding due to potential impacts (pain/inflammation/infection) from wound instillation of a placebo solution. Hence, the person performing the treatment was unblinded, however, this person did not participate in any trial assessments or data analysis. Study animals were maintained in their normal farrowing pens as per standard farm practice with their dam and litter mates. Piglets had ad lib access to potable water and con- stant

ry safety and efficacy field trials with the principles of Good Clinical Practice (GCP) as laid down in the Council Directive 2001/82/EC and guideline CVMP/VICH/595/98 VICH Topic GL9 Step 7-Guideline on Good Clinical Practices (CVMP approved July 2000). The animal study was performed, with owner consent, at two commercial pig farms in Germany and Italy dedicated to the management of breeding sows. Together, 173 commercially bred male piglets (Danish and Landrace ×Large White) between 3 and 7 days of age and in good health were confirmed suitable for enrolment in the study. Prior power analysis indicated the requirement for a minimum of 80 animals per group to show a significant reduction at the 5% level. Litters with 6–12 male piglets (7 average) were selected for the study at each site. Piglets within a litter were individually identified by ear tag (applied on study Day −2) and spray/pen mark. Piglets within a litter were randomly allocated to treatment or control groups. All study piglets had standard blue spray-on piglet marker dye applied to the scrotum prior to procedures, to blind post-operative observers to any translucent-blue colouring that may have remained following application of treatment. This method of blinding was used rather than a placebo solution, to allow comparison with standard castration practice, and prevent confounding due to potential impacts (pain/inflammation/infection) from wound instillation of a placebo solution. Hence, the person performing the treatment was unblinded, however, this person did not participate in any trial assessments or data analysis. Study animals were maintained in their normal farrowing pens as per standard farm practice with their dam and litter mates. Piglets had ad lib access to potable water and con- stant

rrier effect, numbing the pain of lesions, rapidly reducing their infectivity, and hastening healing, potentially reducing the weight loss in affected individuals (Windsor et al., 2020). If made available for purchase and administration by farmers, this product could provide a viable alternative approach for managing FMD in Cameroon, other African countries and developing countries globally. This formulation offers numerous advantages over current therapies as it provides efficacious pain relief and more rapid healing of wounds and lesions (Windsor et al., 2016; Roberts and Windsor, 2019; Windsor et al., 2020). Further, with a pH of ˜2.7, and containing the antiseptic cetrimide, it potentially has viricidal impacts and anti-bacterial properties respectively, avoiding the need for other treatments, including antibiotics (Windsor et al, 2020). In November 2019, TS was provided to the Cameroon research team for trials during FMD outbreaks in cattle. This report describes a field trial in Cameroon aimed at evaluating the efficacy of this therapy for FMD lesion management, particularly for enhancing recovery and wound healing, comparing the clinical responses to the most commonly used and available antimicrobial therapy currently in use. If TS is proven to be as efficacious for FMD in this current study as it appeared to be on first use in Laos as described (Windsor et al., 2020), it is likely that the product could offer an important innovation for improving FMD lesion treatment, potentially globally, with reduced animal welfare burdens, risks of AMR issues and possibly, increased transboundary disease reporting and surveillance. MATERIALS AND METHODS Trial location and design This clinical trial was conducted between the 5th of November and the 5th of December 2019 in

a 11 27.74±5.413b 24.4–32.5 fL B 3 31.50±8.150a 3 28.03±6.550b Mean corpuscular haemoglobin (MCH, pg) A 9 10.62±1.391a 11 9.664±1.097b 8.5–11.8 pg B 3 10.60±1.114a 3 9.533±1.168b Mean corpuscular haemoglobin concentration (MCHC, g/dL) A 9 22.04±2.559 11 35.28±2.734 32.3–42.0 g/dL B 3 34.50±5.112 3 34.63±4.332 For personal use only. Reticulocytes (K/µL) A 9 4.13±4.432 11 2.45±2.987 0.0–15.0 K/μL B 3 1.87±0.153 3 0.77±0.666 Leucocytes (WBC, K/µL) A 7 6.55±1.993a 10 11.06±7.86b 5.06–14.12 K/μL B 3 7.93±3.453a 3 9.17±4.788b Neutrophils (K/µL) A 7 3.66±1.575a 10 7.15±4.403b 1.17–6.11 K/μL B 3 4.83±2.695a 3 5.81±3.999b Lymphocytes (K/µL) A 7 2.73±0.960 10 3.39±1.037 2.54–9.6 K/μL B 3 2.51±0.933 3 2.41±0.925 Monocytes (K/µL) A 7 0.06±0.055a 10 0.32±0.289b 0.1–1.01 K/μL B 3 0.27±0.138a 3 0.90±0.638b Eosinophils (K/µL) A 7 0.01±0.007 10 0.08±0.111B 0.05–0.95 K/μL B 3 0.02±0.011 3 0.01±0.010A Basophil (K/µL) A 7 0.09±0.048 10 0.11±0.081 0–0.12 K/μL B 3 0.03±0.026 3 0.04±0.030 Platelets (K/µL) A 9 531.89±125.926 10 456.60±203.644 301–922 K/μL B 3 758.33±359.433 3 453.67±279.001 Notes: a,bDifferent letters mean significant differences between results in day one and day 11 (p<0.05); A,BDifferent letters mean significant differences between the two groups A and B (p<0.005). virus transmission during outbreaks. Similarly, hypocrellin shown to provide rapid and prolonged wound anaesthesia A antiviral activity seems to be related to a decline in from blockage of nociception,16 with the acidity poten­ pH.15 Low pH has been related to viricidal activity in tially sufficient to destroy virus without causing pain to the multiple models, including Herpes Simplex-1 (HSV-1) in animal. It has also been postulated