Hot Topics in Wound Care 1 Topical vs Transdermal 2 Topical / - PowerPoint PPT Presentation

Hot Topics in Wound Care 1

Topical vs Transdermal 2

Topical / Transdermal Oxygen 3

Mechanism of Action Topical / Transdermal Oxygen ➢ Full thickness excisional wounds ➢ Seldinger technique to place a probe directly beneath the wound surface ➢ Central wound pO2 increased from a baseline of 5-7 mmHg to levels >40 mmHg Fries et al.; Mutat Res. 2005 4

Mechanism of Action Topical / Transdermal Oxygen ➢ Promotion of VEGF ➢ Increased Angiogenesis Pre Treatment Post Treatment 5

Literature Review Topical / Transdermal Oxygen 6

OxyBand Sustained Transdermal Oxygen System ➢ Transdermal Drug Delivery Patch containing O2 ➢ O2 diffuses across high permeability film, saturates the wound fluid, provides continuous supply ➢ Feel of conventional dressings or transdermal patch 7

OxyBand How Does it Work? ➢ A therapeutic advanced oxygen reservoir device with the capability of delivering sustained oxygen substrate for up to 5 days to enhance the wound microenvironment. ➢ OxyBand is applied over the wound and provides medical grade oxygen from the reservoir to the wound. ➢ Oxygen diffuses across a permeable membrane and is occluded from escaping into the atmosphere. 8

OxyBand Research & Evidence ➢ Delivers Oxygen Up To 5 Days, Oxygen Transfer Study ➢ Delivers Oxygen into wounds (PO2 to 264 mmHg) ➢ Increases Wound O2 After HBOT - Complementary ➢ Versus Standard of Care (Randomized Controlled ) ➢ Versus Placebo (Double Blind Randomized Controlled) ➢ Effective Healing, Diabetic & Venous Ulcers (Case Studies) ➢ Improves Neutrophil killing of Pathogens � Acinetobacter baumannii (In Vitro) ➢ Oxygen increases the efficacy of Silver efficacy � Pseudomonas Aeruginosa & MRSA ➢ Definitive Army USAISR Pre Clinical & Clinical Trial 9

Does OxyBand Increase Dissolved Wound Oxygen? 10

Methods ➢ 2 pigs (HBOT and control) ➢ 8 standardized full thickness wounds per pig ➢ Wounds covered with thin film or OxyBand dressing Harriet W. Hopf, MD 1 , Gerit Mulder, DPM 2 , Jay Duchnick, CHT 3 , Scott Barnhill, AS, SRS, RLA TG . An Oxygen � Reservoir Dressing Sustains Elevated Wound pO2 After Hyperbaric Oxygen Treatment 11

Methods ➢ O2 measured within wound exudate using polarographic micro-electrodes � MI-730 and OM-4 oxygen monitor, Micro-Electrodes, Inc, Bedford NH � Type K thermocouple 5SC-TT-K-36-36 and HH11A monitor, Omega Engineering, Stamford CT ➢ 2-3 mm depth wounds ➢ 2hr / 8hr / 16hr after OxyBand & (control) ➢ 15m / 2hr / 12hr after HBOT – OxyBand & Control � HBOT=90 min at 2 ATA Harriet W. Hopf, MD 1 , Gerit Mulder, DPM 2 , Jay Duchnick, CHT 3 , Scott Barnhill, AS, SRS, RLA TG . An Oxygen � Reservoir Dressing Sustains Elevated Wound pO2 After Hyperbaric Oxygen Treatment 12

Results Harriet W. Hopf, MD 1 , Gerit Mulder, DPM 2 , Jay Duchnick, CHT 3 , Scott Barnhill, AS, SRS, RLA TG . An Oxygen � Reservoir Dressing Sustains Elevated Wound pO2 After Hyperbaric Oxygen Treatment 13

Conclusion ➢ pO2 was higher in OxyBand vs. control at baseline � Even given high inspired O2 ➢ pO2 (control) remained elevated for <2 h after HBOT ➢ pO2 (OxyBand) remained elevated 12 h after HBOT ➢ Synergies of HBOT and prolonged local oxygen Harriet W. Hopf, MD 1 , Gerit Mulder, DPM 2 , Jay Duchnick, CHT 3 , Scott Barnhill, AS, SRS, RLA TG . An Oxygen � Reservoir Dressing Sustains Elevated Wound pO2 After Hyperbaric Oxygen Treatment 14

OxyBand vs Standard Care *All Day 3 and Day 7 primary endpoints demonstrated statistical significant differences (p < .001) 15

OxyBand Vs. Placebo (Air Filled Dressing) Results showed a significant difference in healing time of 30% 16

OxyBand Vs. Placebo (Air Filled Dressing) 17

OxyBand Vs. Placebo (Air Filled Dressing) 18

USAISR RCT – STSG Donor Sites 19

Published Prospective RCT US ARMY (USAISR) Kimberly F. Lairet, MD, Leopoldo C. Cancio, MD, Michelle L. Leas, RN, Chaya Galin, RN, David Baer, PhD, Evan M. Renz, MD Evaluation of an Oxygen Diffusion Dressing for Accelerating Healing of Donor Site Wounds. Journal of Burn Care and Rehabilitation 1997;18(4):353-5 United States Army Institute of Surgical Research, Fort Sam Houston, TX 20

Objective of the DOD Research ➢ Primary objective, determine if autogenous donor sites heal faster with OxyBand than Control � Control Group = Xeroform dressing ➢ Secondary objective, determine whether the antimicrobial efficacy of silver is affected by higher oxygen levels. ➢ OxyBand also evaluated increased % O2 on PMN bactericidal killing of Acinetobacter 21

Results Outcome OxyBand Xeroform 9.4 ± 1.7 days (range 6- 12.4 ± 2.7 days (range 8-20 Healing Time 12 days) days) No Infection (Blinded Evaluation of No Infection Significantly Faster Photographic Evidence) (p<0.01) Healing w/ OxyBand Pain (0-10 Scale on Day Day 4, 0.6 Vs 1.6 (~ 3x more pain) Vs 1.4, (> 3x Day 8, O.4 more pain) Vs 0.8, (> 2x more pain Vs 4,8,10,12) Day 10, 0.3 0.5 (> 2x more pain) Significantly (p<0.05) Day 12, 0.2 More Pain with Xeroform Significantly Less Pain with OxyBand Kimberly F. Lairet, MD, Leopoldo C. Cancio, MD, Michelle L. Leas, RN, Chaya Galin, RN, David Baer, PhD, Evan M. Renz, MD Evaluation of an Oxygen Diffusion Dressing for Accelerating Healing of Donor Site Wounds. Journal of Burn Care and Rehabilitation 1997;18(4):353-5 United States Army Institute of Surgical Research, Fort Sam Houston, TX 22

The Effect of Higher Levels of O2 (80%) on the Efficacy of Silver To Kill Bacteria (in vitro) 23 23

In vitro characterization of pressure redistribution among commercially available wound dressings Jeffrey A Niezgoda MD, FACHM, MAPWCA, CHWS 1* Sandeep Gopalakrishnan MS, PhD, DAPWCA 2 , Jonathan A Niezgoda MA 1 and Amie Franklin, PhD 3 24

400 Average Pressure (mmHg) 300 200 100 0 Control Cutimed Siltec B Eclypse Adherent Optifoam Aquacel Foam Tielle Plus Sacrum Tielle Essential Drawtex Surgical Drawtex Mepilex Border Mepilex Border Heel Allevyn Life Allevyn Life Sacrum OxyBand PR OxyBand Foam Commerical Dressing Materials Dunnett's multiple comparisons test Mean Diff. 95.00% CI of diff. Significant? Summary Adjusted P Value Control vs. Cutimed Siltec B 178 163 to 192 Yes **** <0.0001 Control vs. Eclypse Adherent 25 11 to 40 Yes *** 0.0002 Control vs. Optifoam 157 142 to 171 Yes **** <0.0001 Control vs. Aquacel Foam 157 142 to 171 Yes **** <0.0001 Control vs. Tielle Plus Sacrum 194 180 to 209 Yes **** <0.0001 Control vs. Tielle Essential 184 170 to 199 Yes **** <0.0001 Control vs. Drawtex Surgical 35 21 to 50 Yes **** <0.0001 Control vs. Drawtex 63 49 to 77 Yes **** <0.0001 Control vs. Mepilex Border 156 142 to 171 Yes **** <0.0001 Control vs. Mepilex Border Heel 160 146 to 175 Yes **** <0.0001 Control vs. Allevyn Life 171 157 to 185 Yes **** <0.0001 Control vs. Allevyn Life Sacrum 238 224 to 252 Yes **** <0.0001 Control vs. OxyBand PR 252 238 to 267 Yes **** <0.0001 Control vs. OxyBand Foam 253 238 to 267 Yes **** <0.0001 25

26 Contact Area (cm 2 ) 10 20 30 0 Control Cutimed Siltec B Eclypse Adherent Optifoam Commerical Dressing Materials Aquacel Foam Tielle Plus Sacrum Tielle Essential Drawtex Surgical Drawtex Mepilex Border Mepilex Border Heel Allevyn Life Allevyn Life Sacrum OxyBand PR OxyBand Foam

***p<0.0001, significantly different from Coontrol 1000 800 **** Peak Pressure (mmHg) **** 600 **** **** 400 **** 200 0 Control Cutimed Siltec B Eclypse Adherent Optifoam Aquacel Foam Tielle Plus Sacrum Tielle Essential Drawtex Surgical Drawtex Mepilex Border Mepilex Border Heel Allevyn Life Allevyn Life Sacrum OxyBand PR OxyBand Foam Dunnett's multiple comparisons test Mean Diff. 95.00% CI of diff. Significant? Summary Adjusted P Value Commerical Dressing Materials Control vs. Cutimed Siltec B 0 -37.56 to 37.56 No ns >0.9999 Control vs. Eclypse Adherent 0 -37.56 to 37.56 No ns >0.9999 Control vs. Optifoam 0 -37.56 to 37.56 No ns >0.9999 Control vs. Aquacel Foam 0 -37.56 to 37.56 No ns >0.9999 Control vs. Tielle Plus Sacrum 118 80.44 to 155.6 Yes **** <0.0001 Control vs. Tielle Essential 0 -37.56 to 37.56 No ns >0.9999 Control vs. Drawtex Surgical 0 -37.56 to 37.56 No ns >0.9999 Control vs. Drawtex 0 -37.56 to 37.56 No ns >0.9999 Control vs. Mepilex Border 0 -37.56 to 37.56 No ns >0.9999 Control vs. Mepilex Border Heel 0 -37.56 to 37.56 No ns >0.9999 Control vs. Allevyn Life 344 306.4 to 381.6 Yes **** <0.0001 Control vs. Allevyn Life Sacrum 359.7 322.1 to 397.2 Yes **** <0.0001 Control vs. OxyBand PR 516.7 479.1 to 554.2 Yes **** <0.0001 Control vs. OxyBand Foam 199.3 161.8 to 236.9 Yes **** <0.0001 27