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Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman...

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Negative pressure wound therapy with hard-to-heal wounds Dr Caroline Dowsett Nurse Consultant Tissue Viability
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Page 1: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Negative pressure wound therapy with hard-to-heal wounds

Dr Caroline Dowsett

Nurse Consultant

Tissue Viability

Page 2: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Disclaimer

The information presented is solely for informational and educational purposes. Smith & Nephew does not provide medical advice. The presentation is not intended to serve as medical advice. The presentation reflects the views of the presenter and does not necessarily represent the view of Smith & Nephew. It is the treating health care provider's responsibility to determine

the best course of treatment for their patients based upon their professional medical judgement. Responsibility for obtaining permission to use images contained in this presentation is that of the

presenter, not Smith & Nephew.

For detailed product information, including indications for use, contraindications, effects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use. The presentation and the information presented may not be appropriate for all jurisdictions.Products may not be available in all markets because product availability is subject to the

regulatory and/or medical practices in individual markets.

Page 3: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Learning objectives

1. To understand what a hard-to-heal wound is and the impact on the patient, clinician and health economy

2. Discuss factors that contribute to hard-to-heal wounds

3. To understand the role of NPWT and sNPWT in improving outcomes in patients with hard-to-heal wounds

Page 4: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

What is a hard-to-heal wound?

• A hard-to-heal wound has been defined as one that fails to heal with standard therapy in an orderly and timely manner1

Page 5: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Hard-to-heal wounds

• Have a significant impact on patients and their quality of life

• Place a significant burden on our healthcare systems globally

Page 6: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Hard-to-heal wounds

• 1.5-2million people in Europe suffer from acute or chronic wounds2

• Average duration is 9-12 months and 29% remain unhealed at 1 year3

• 17.8% of patients have their wound for 1-5 years4

Page 7: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Patients with hard-to-heal wounds: complexity of our patients

• 76% of patients with a chronic wound have three or more co-morbidities5

• 46% have diabetes5

• 52% of the adult population across Europe are overweight and 17% are obese6

Page 9: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Challenge for clinicians

• Healthcare professionals time to treat —79% treated in the community2

• Knowledge, skills and competencies• Preventing and managing complications• Timely referrals for advanced therapies

Page 10: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Challenge for the healthcare provider

• Increasing cost of care• Multiple demands on limited resources• Drive for efficiencies and reducing waste• Improving outcomes for patients

Page 11: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Recognition and early intervention

• Delayed healing appears to be common• It is frequently not recognised early enough • Increases clinical workloads and cost• More pro-active approach to early assessment and

intervention for these patients

Page 12: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Assessment: factors that contribute to hard-to-heal wounds

• Patient-related factors• Wound-related factors• Clinical competency factors• Resources and treatment-related factors

Page 13: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Management of hard-to-heal wounds

• Correct diagnosis of wound aetiology and treatment of the underlying cause

• Manage underlying co-morbidities and factors impact on wound healing

• Applying the principles of wound bed preparation• Targeted use of advanced wound care products e.g.

negative pressure wound therapy (NPWT)• Ongoing reassessment and evaluation

Page 14: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Introduction to NPWT

TraumaticHard-to-

heal & chronic

Flaps and grafts

Acute

Closed surgical incisions

Subacute & dehisced

wounds

Ulcers

Partial-thickness

burns

Examples of wound types

• The controlled application of sub-atmospheric pressure to the local wound environment, using a sealed wound dressing which is connected to a vacuum pump

Page 15: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Mechanism of action (MOA)

Promotes granulation tissue formation10,11 and epithelialisation9*

Increases blood flow12

Reduces oedema13,15

Removes wound fluid12,15,16 and reduces the risk of maceration9,14

Protects from external contamination in vitro8

NPWT may work by multiple mechanisms of action7

*as demostarted in vivo

Page 16: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Study of sNPWT in hard-to-heal wounds3*

• Multi-centre and economic evaluation study: N = 52 patients

• Developed and implemented a pathway for use of sNPWT to ‘kick start hard-to-heal wounds’

• Evaluated the impact on clinical outcomes and cost

*Single use negative pressure wound therapy (sNPWT)

Page 17: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Study results3

In a multi-cente clinical + economic evaluation based on a pathway for use of sNPWT over 12 weeks

Costs

total cost savings

vs predicted standard care over 26 weeks

33.1%

(£50,000 over a 26 week period)

Wound healing

94.1%

Time to care

119 days

(143 days saved based on projected healing)

Wound size

of wounds <3 months

duration healed or projected to heal within 12

weeks

Released over 26 weeks

Intention-to-treat population

(n=52)Significant improvement in

wound area reduction

Wound area reduced by 13.4% more than

the pre-PICO rate (p=0.006)

Page 18: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Hard-to-heal wounds and sNPWT17

healing rate for wounds

84.6%of <3 months in duration

Dressing changes significantly reducedduring and after sNPWT use

(p<0.001 vs standard care)

Wou

nd h

ealin

g (%

)

100

84.6%

Predicted savings with PICO sNPWT versus standard care

80 71.4% 59% 21–25%

for nursing for total cost cost resource

60

40 33.3%

20 14.3%

0 <3 months 3-6 months 6-12 months >12 months

Figure. Wound healing by durat ion of wound at baseline and predicted cost savings with use of PICO sNPWT

1 of 7 wounds

3 of 9 wounds

5 of 7 wounds

11 of 13 wounds

Wou

nd h

ealin

g (%

)

Saving estimates based on economic modelling (n=36)

Page 19: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

NPWT compared to sNPWT18

Wound depth

greater reduction 32.5%

(45.6 vs 13.2%; p=0.014)

Wound closure

relative increase 51.0%

in patients achieving wound closure

Wound volume

greaterimprovement

91.1%

(48.6 reduction vs 42.5% increase;

p=0.013)

Wound area

greater reduction

39.1%

(90.2 vs 51.0%; p<0.001)

In a multi-cente randomised, controlled study, use of sNPWT helped to significantly reduce wound area, depth and volume compared with tNPWT in patients with lower extremity wounds (venous leg ulcers and diabetic foot ulcers) over 12 weeks

Intention-to-treat population

(n=161)

Page 20: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

PICO◊ sNPWT delivers NPWT across the dressing to surrounding tissue*

PICO sNPWT delivers compressive forces across and beyond the wound spanning the entire dressing

(within 60mm of wound centre line)19

PICOsNPWT

24h post application

tNPWT delivers localised therapy to the wound itself

(within 35mm of wound centre line)19

24h post application

tNPWT

*A benchtop model using metallic markers inserted into porcine tissue at 10mm intervals (total 150mm). Tissue displacement was analysed at the wound bed, edge of dressing and outside the dressing using computed tomography.19

Page 21: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Advances in sNPWT technology

NEW PICO◊ 14Designed to challenge hard-to-heal wounds

•Pump duration of up to 14 days20

•Designed for use on deeperwounds21**

•Enhanced pump to aid use in large wounds with less userintervention22*

Footnote: *Compared with previous versions; **19 case studies; wound depths 2-7cm

Page 22: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Technology and innovation: PICO◊ 14

• 44-year-old patient• Diabetes, MI• Incision and drainage of an abscess• No infection• On referral 8cm X 2cm and 0.5cm deep• tNPWT• Dressing changed twice a week

Results will vary

Page 23: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Progress

• Week 1. 5cm X 1cm and superficial• Week 2. 4.5cm X 1cm• Week 4 Healed• Reduction in dressing change – 1 a week• Patient reported satisfaction score 10

Results will vary

Footnote: The PICO Dressing has a wear time of up to 7 days, depending on exudate levels

Page 24: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Early intervention

• 36-year old patient• Body mass index (BMI) 40• Hypertension• Hyperlipidaemia• Hernia repair• Post-op infection• Surgical dehiscence • Dressings X 3 week

Results will vary

Page 25: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Progress

• Static wound• 4cm X 1cm and 3cm deep• High levels of exudate• PICO◊ 14 applied• Week 1. 2cmX 0.5cm and 0.5 deep• Week 2. 1.5cm X 0.4cm and 0.3cm deep• Healed at week 3• Patient reported satisfaction score 10

Results will vary

*PICO◊ 14 is indicated for patients who would benefit from a suction device (NPWT) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials.

Page 26: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Conclusion

• Hard to heal wounds are challenging for patients, clinicians & the health economy

• Need to identify patients who are likely to be hard to heal early

• Use evidence based interventions to help reduce time to healing & improve patient outcomes

Page 27: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

References

1. Troxler M, Vowden K, Vowden P. Integrating adjunctive therapy into practice: the importance of recognising ‘hard-to-heal’ wounds. World wide wounds 2006. Available from: http://www. worldwidewounds.com/2006/december/ Troxler/Integrating-Adjunctive-Therapy-IntoPractice.html

2. Lindholm C, Searle R. Wound management for the 21st century: combining effectiveness and efficiency. International Wound Journal. 2016;13 (suppl. S2):5–15

3. Dowsett et al. Use of PICO◊ to improve clinical and economic outcomes in hard-to-heal wounds. Wounds International. 2017;8, p53–58.

4. Ousey K, Stephenson J, Barrett S et al. Wound care in five English NHS Trusts. Results of a survey. Wounds UK. 2012;9(4): 20–8

5. Dowsett et al. Reducing the burden of chronic wounds in the community with single-use NPWT. JCN supplement. 2015;29(5)

6. OECD. Overweight and obesity among adults. In: Health at a Glance: Europe 2012, OECD Publishing, 2012.

7. Karlakki S, Brem M, Giannini S, Khanduja V, Stannard J, Martin R. Negative pressure wound therapy for management of the surgical incision in orthopaedic surgery: A review of evidence and mechanisms for an emerging indication. Bone Joint Res. 2013;2(12):276-84.

8. Smith & Nephew February 2011. Bacterial Barrier Testing (wet-wet) of PICO dressing with a 7 day test duration against S. marcescens. Internal Report. 1102010.

9. Brownhill R. Pre-clinical assessment of Single-use negative pressure wound therapy during in vivo porcine wound healing. Data on file report. August 2019. DS/19/313/R.

10. Dunn R, Hurd T, Chadwick P, et al. Factors associated with positive outcomes in 131 patients treated with gauze-based negative pressure wound therapy. Int J Surg. 2011;9(3):258-262.

11. Young SR, Hampton S, Martin R. Non-invasive assessment of negative pressure wound therapy using high frequency diagnostic ultrasound: oedema reduction and new tissue accumulation. Int Wound J. 2013;10(4):383-388.

12. Malmsjö M, Huddleston E, Martin R. Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty. 2014;14:e15.

13. Canonico S, Campitiello F, Della Corte A, et al. Therapeutic possibilities of portable NPWT. Initial multidisciplinary observation with the negative pressure therapy device. Acta Vulnologica. 2012;10:57-66.

14. Smith & Nephew May 2015. A prospective, open, non-comparative, multi-centre study to evaluate the functionality and dressing performance of a new negative pressure enhanced dressing (NPED)in acute wounds (CT09/02). Internal Report. ST865 CT09/02.

15. Smith & Nephew June 2018. Summary Wound Model Report for PICO 7Y. Internal Report. DS/18/219/R V2.

Page 28: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

References

16. Lalezari S, Lee CJ, Borovikova AA, et al. Deconstructing negative pressure wound therapy. Int Wound J. 2017;14:649-657.

17. McCluskey P, Brennan K, Mullan J, et al. Impact of a single-use negative pressure wound therapy system on healing. JCN. 2020;34:36–43.

18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities. Wound Repair and Regeneration. May 2019. https:// doi.org/10.1111/wrr.12727.

19. Brownhill R. PICO◊ Biomechanical Study. Data on file report. August 2019. DS/19/211/R.

20. Smith & Nephew December 2018. PICO 14 Service Life Testing: 14 Day Device Lifespan. Internal Report. RD/18/132.

21. Smith & nephew 2018. The review of evidence supporting the use of PICO in wounds ≥2cm in depth. Internal report EO AWM. PCS230.001 v2.

22. Smith & Nephew 2019. Research & Development Report. PICO 14 and PICO 7 Initial Pump Down and Maintenance Pump Down Time Outs RD/19/084.

◊ Trademark of Smith+Nephew. All Trademarks acknowledged. © June 2020 Smith+Nephew 25947

Page 29: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Hard to Heal Resources

Kirsner et al., 2019 Evidence in Focus

PICO 14 Hard to Heal eDetailer

Dowsett et al., 2017 Evidence in Focus

McCluskey et al., 2020 Evidence in Focus

Page 30: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

Hard to Heal Resources

For further information on PICO◊ or the evidence presented please contact us by

Email : [email protected]

Or

Visit: www.smith-nephew.com/PICO

Page 31: Negative pressure wound therapy with hard-to-heal wounds€¦ · 18. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the

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