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

Hot Topics in Wound Care

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Topical vs Transdermal

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Topical / Transdermal Oxygen

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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

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Literature Review Topical / Transdermal Oxygen

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➢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

OxyBand

Sustained Transdermal Oxygen System

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➢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.

OxyBand How Does it Work?

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➢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

OxyBand Research & Evidence

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Does OxyBand Increase Dissolved Wound Oxygen?

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➢2 pigs (HBOT and control) ➢8 standardized full thickness wounds per pig ➢Wounds covered with thin film or OxyBand dressing

Methods

• Harriet W. Hopf, MD1, Gerit Mulder, DPM2, Jay Duchnick, CHT3, Scott Barnhill, AS, SRS, RLA
• TG. An Oxygen

Reservoir Dressing Sustains Elevated Wound pO2 After Hyperbaric Oxygen Treatment 11

➢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

Methods

• Harriet W. Hopf, MD1, Gerit Mulder, DPM2, Jay Duchnick, CHT3, Scott Barnhill, AS, SRS, RLA
• TG. An Oxygen

Reservoir Dressing Sustains Elevated Wound pO2 After Hyperbaric Oxygen Treatment 12

Results

• Harriet W. Hopf, MD1, Gerit Mulder, DPM2, Jay Duchnick, CHT3, Scott Barnhill, AS, SRS, RLA
• TG. An Oxygen

Reservoir Dressing Sustains Elevated Wound pO2 After Hyperbaric Oxygen Treatment 13

➢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

Conclusion

• Harriet W. Hopf, MD1, Gerit Mulder, DPM2, Jay Duchnick, CHT3, 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)

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OxyBand Vs. Placebo

(Air Filled Dressing)

Results showed a significant difference in healing time of 30%

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OxyBand Vs. Placebo

(Air Filled Dressing)

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OxyBand Vs. Placebo

(Air Filled Dressing)

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USAISR RCT – STSG Donor Sites

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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

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➢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

• xygen levels.

➢OxyBand also evaluated increased % O2 on PMN bactericidal killing of Acinetobacter

Objective of the DOD Research

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Results

Outcome OxyBand Xeroform

Healing Time (Blinded Evaluation of Photographic Evidence) (p<0.01) 9.4±1.7 days (range 6- 12 days) No Infection Significantly Faster Healing w/ OxyBand 12.4±2.7 days (range 8-20 days) No Infection Pain (0-10 Scale on Day 4,8,10,12) (p<0.05)

Day 4, 0.6 Day 8, O.4 Day 10, 0.3 Day 12, 0.2

Significantly Less Pain with OxyBand

Vs 1.6 (~ 3x more pain) Vs 1.4, (> 3x more pain) Vs 0.8, (> 2x more pain Vs 0.5 (> 2x more pain) Significantly

More Pain with Xeroform

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

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

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In vitro characterization of pressure redistribution among commercially available wound dressings

Jeffrey A Niezgoda MD, FACHM, MAPWCA, CHWS1* Sandeep Gopalakrishnan MS, PhD, DAPWCA2, Jonathan A Niezgoda MA1 and Amie Franklin, PhD3

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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 100 200 300 400

Commerical Dressing Materials Average Pressure (mmHg)

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

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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 10 20 30

Commerical Dressing Materials Contact Area (cm2)

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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 200 400 600 800 1000

Commerical Dressing Materials Peak Pressure (mmHg)

**** **** **** **** ****

***p<0.0001, significantly different from Coontrol

Dunnett's multiple comparisons test Mean Diff. 95.00% CI of diff. Significant? Summary Adjusted P Value 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

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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 200 400 600 800 1000

Commerical Dressing Materials Peak Pressure (mmHg)

**** **** **** **** ****

***p<0.0001, significantly different from Control #p<0.05, significantly different from Tielle Plus Sacrum @p<0.05, significantly different from Allevyn Life(AL), AL Sacrum, Oxyband Foam

# # # #

@

Tielle Plus Sacrum vs. Allevyn Life 226 151.9 to 300.1 Yes **** <0.0001 Tielle Plus Sacrum vs. Allevyn Life Sacrum 241.7 167.5 to 315.8 Yes **** <0.0001 Tielle Plus Sacrum vs. OxyBand PR 398.7 324.5 to 472.8 Yes **** <0.0001 Tielle Plus Sacrum vs. OxyBand Foam 81.33 7.217 to 155.5 Yes * 0.0318 Allevyn Life vs. Allevyn Life Sacrum 15.67

• 58.45 to 89.78

No ns 0.9433 Allevyn Life vs. OxyBand PR 172.7 98.55 to 246.8 Yes *** 0.0003 Allevyn Life vs. OxyBand Foam

• 144.7
• 218.8 to -70.55

Yes *** 0.001 Allevyn Life Sacrum vs. OxyBand PR 157 82.88 to 231.1 Yes *** 0.0006 Allevyn Life Sacrum vs. OxyBand Foam

• 160.3
• 234.5 to -86.22

Yes *** 0.0005 OxyBand PR vs. OxyBand Foam

• 317.3
• 391.5 to -243.2

Yes **** <0.0001

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10 20 30 100 200 300 400

Contact Area (cm2) Average Pressure (mmHg) R2=0.73 p<0.0001

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Chronic Wound after 2 Y ear of Ineffective Treatment Concrete Chemical Burn

Chronic 2 Y ear Wound OxyBand- 30 Day OxyBand- 90 Day

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Case Studies

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➢Surgical Wounds

Post operative, Donor Sites, SSSI

➢Venous Insufficiency ➢Diabetic Foot Ulcers ➢Pressure Ulcers

Specific Wound Types

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Thank You…

Questions

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