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8 February

© 3M 2023. All Rights Reserved. 3M Confidential. 1


About Assistant Prof. Chew Khong Yik
About Mr Chew Khong Yik

Mr Chew Khong Yik obtained his medical qualification from


National University of Singapore in 2002 and qualified as a plastic
surgeon in 2013. He was awarded the 2012 Health Manpower
Development Program for Reconstructive Microsurgery and
completed his fellowship in head and neck cancer reconstruction
in 2013.

He is a Senior Consultant in Singapore General Hospital and


KK Women’s and Children’s Hospital, as well as the National
Cancer Centre. Dr Chew has an active interest in major burns,
head and neck cancer reconstruction, tissue transplantation and
trauma.

8 February
© 3M 2023. All Rights Reserved. 3M Confidential. 2
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Learning Objectives

• Understanding the basic mechanisms behind NPWTi-d


and Advantages over conventional NPWT

• Evidence for use of NPWTi-d for infected orthopedic


implants

• Clinical perspectives in approaching infected implant


salvage with NPWTi-d

• Case Studies in NPWTi-d for infected orthopedic


implants

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Disclaimer
The presentations contain case studies and clinical reports based upon personal clinical experience and
research. Results may not be typical and individual results may vary. Please refer to the Essential
Prescriber Information for product indications for use .
Users should read and understand all Instructions for Use, including essential prescriber and safety
information, prior to application of any product.
The photographs contained in this slide deck are the presenters unless otherwise indicated.
Proper surgical procedures & techniques are necessarily the responsibility of the medical professional.
Each surgeon must evaluate the appropriateness of the technique based on his or her own medical
training and expertise
Trademarks used herein are trademarks of their respective owners.
3M and the other marks shown are marks and/or registered marks. Unauthorized use
prohibited.

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What is Negative Pressure Wound Therapy?
The V.A.C.® Therapy Unit provides software-controlled
negative pressure wound therapy
Canister: collects the wound exudate
SENSAT.R.A.C.™ Technology pad: monitors and maintains
pressure at the wound site to provide delivery of prescribed
negative pressure settings
Drape: helps provide a moist wound healing environment
Foam: Contract under negative pressure, providing direct
and complete contact with the wound bed
• The 400-600 micron reticulated pores help distribute
pressure through the wound bed
• Polyurethane, hydrophobic (moisture repellant)
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Terminology
• NPWT: Negative Pressure Wound Therapy:
(“V.A.C”)
• NPWTi-d: Negative Pressure Wound Therapy
with installation and dwell time (“Veraflo™”)
• Negative pressure therapy with cyclic delivery, dwell
time and removal of topical solutions
• Solutions commonly used: normal saline, iodine in dilute
concentrations, chlorhexidine, Prontosan, etc
• Purpose:
• Solubilize debris
• Antisepsis
• Moisturize and prevention of desiccation
• Avoiding granulation tissue ingrowth
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Changes in NPWT at Cellular Level


Blood Cells migrate
Vessel into pores
Organized
Protein infiltrate into pores. matrix Blood
Serves as scaffold for cells Granulation
Tissue Vessel
Granulation
Tissue

1 mm
Day 1 Day 2 Day 3 Day 4

M. Morykwas, "Sub-atmospheric Pressure Therapy: Research Evidence," in Topical Negative Pressure (TNP) Therapy
Proceedings, P. Banwell, L. Teot, eds., TMP Communcations, Faringdon, UK, 2004, p 39-45.

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WHY NPWT: MECHANISM OF ACTION
Macrostrain: tissue expansion (wound edges are drawn together)
Microstrain: cell stretch → increased cell activity
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NPWT (ActiV.A.C.™ Therapy System)


vs NPWTi-d (Veraflo™ Therapy)

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NPWTi-d: Benefits over Conventional NPWT

Added Benefits:

• Facilitated removal of
microorganisms (antiseptics)

• Dilution of inflammatory and


cytotoxic macromolecules

• Additional wound hydration

• Enhanced angiogenesis
through intermittent
application of NPWT.

Aycart et al. Mechanisms of Action of Instillation and Dwell Negative Pressure Wound Therapy with Case Reports of Clinical Applications. Cureus 10(9): e3377.
Efficacy of NPWT
Bedside Debridement and regular changes of dressings:
• - ActiV.A.C. Therapy System is still the most effective for removal of slough and promotion of granulation

Before Treatment Day 20 Day 30 Day 45


Efficacy of NPWTi-d
Bedside Debridement and regular changes of dressings:
• - ActiV.A.C. Therapy System is still the most effective for removal of slough and promotion of granulation

Before Treatment Day 20 Day 30 Day 45

Skin Graft Application (Day 45) Day 60


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Effectiveness of NPWTi-d
Infected wound 3 weeks

6 weeks 6 weeks

• Efficacy of NPWTi-d is undisputed


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Orthopedic Implant Infections: Types of Implants & Risk

• Prosthetic joint and or bone replacement


• Joint replacement: Hip, knee, ankle arthroplasty
• Bone replacement: mega-prosthesis/mega implants
• Cancers, osteomyelitis, etc
• Risk of infection:
• Primary Hip/Knee Replacement: 1.5% - 2.5%
• Revision: 3.2 – 5.6%
• Megaprosthesis: Up to 15% (Hanssen et al 1999)

• Trauma related bone fixation:


• Tibial plateau, ankle fractures, etc
• Risk of infection: 0.4% - 16.1% depending on type of fractures (Zimmerli et al 2007)
Management of Orthopedic Implant Infections (Traditional)
1. Debridement + retention of prosthesis
- 30-80% successful retention of implants (Crockarell et al. 1998, JBJSAm(80):1316-1313)
- Suction-irrigation has been described since 1989 for infected implants (Mella-Schmidt et al. Chirug 60(11):791-794)

2. One-stage replacement
- Only successful in very early-stage infections, superficial infections

3. Two-stage replacement
- Removal of implant (Crockarell et al. 1998, JBJSAm(80):1316-1313)
- Placement of antimicrobial carrier
- Replacement of new prosthesis at least 6 weeks later

4. Removal of implant without replacement


Two-stage replacement
- Usually results in significant morbidity, loss of function Yi et al. Surgical Infections 2015: 16(10)
Evidence of NPWTi-d

1. Debridement, systemic antibiotics only


- low chance of successful retention of implants: 30% (Cockarell et al.)

2. Suction-irrigation has been described since 1989 for infected implants


- higher success rate of up to 60% (Mella-Schmidt et al. Chirug 60(11):791-794)

3. Vacuum-instillation system first described in 1998 (Fleishman et al.)

4. Vacuum system described in 1997 (Morykwas et al.)

5. NPWTi-d for bone infection was described in 2009 (Timmers et al.)

6. NPWTi-d for orthopedic implant infection was first reported in 2011 (Lehner et al.)
Evidence of NPWTi-d in Orthopedic Implant Infections
Evidence of NPWTi-d in Orthopedic Implant Infections
(Lehner 2011)

1. Retention of implant as high as 80% for chronically infected implant


2. Retention of implant 86% for acutely infected implant
3. Number of dressing changes: mean 3.5 times (range 1-8)
4. Average hospitalization: 35 days (range 12-97)
Evidence in Literature

Dettmers et. al. Ostomy wound management 2016,62(9):30-40


Evidence in Literature: Trimalleolar fracture
- ankle fixation plate exposure

Dettmers et. al. Ostomy wound management 2016,62(9):30-40


Evidence in Literature: Ankle prosthesis
- valgus correction due to rheumatoid arthritis

Dettmers et. al. Ostomy wound management 2016,62(9):30-40


Evidence in Literature

Dettmers et. al. Ostomy wound management 2016,62(9):30-40


Case Discussion 1: Total Ankle Replacement

69-year-old female
• Comorbidities: Type II diabetes mellitus, hypertension
• Diagnosis: severe OA (viêm khớp nặng)
• Procedure: total ankle replacement

Surgery:
• Total ankle arthroplasty
• Customized 3D printed implant
• Surgery uneventful
• Wound closed primarily
Case Discussion 1: Total Ankle Replacement

69-year-old female
• Comorbidities: Type II diabetes mellitus, hypertension
• Diagnosis: severe OA
• Procedure: total ankle replacement

Day 5
Surgery:
• Total ankle arthroplasty
• Customized 3D printed implant
• Surgery uneventful
• Wound closed primarily

• 5-14 days post-op:


• Skin edge purulent discharge → wound edge ischemia → dehiscence → implant exposed

Day 7
Case Discussion 1: Total Ankle Replacement

Suture Debridement
Removal +
+
Debridement Conventional
+ NPWT
Drain

Day 7 Day 10 Day 14


Debridement and Resuturing
Skin necrosis (Cắt chỉ, cắt lọc da hoại tử, Wound dehiscence
(hoại tử) khâu da) + exposed tendon, implant
Case Discussion 1: Total Ankle Replacement

Acute Infection: Strategies


• Culture: Klebsiella sp
• Systemic Antibiotics

• NPWTi-d: 2 weeks
• Irrigation with dilute iodine

• Multiple debridement
Wound dehiscence → Implant Exposure
• Negative cultures x 3 Failed conservative
management
• Change of PTFE liner
Case Discussion 1: Total Ankle Replacement

Wound dehiscence
Case Discussion 1: Total Ankle Replacement

Wound dehiscence Implant Exposure


Rectus muscle flap
Case Discussion 1: Total Ankle Replacement

Wound dehiscence Rectus muscle flap Flap Closed


(vạt cơ trực tràng)
Case Discussion 1: Total Ankle Replacement

Conventional Pressure
NPWT garment

Flap +skin graft Wound inspection D5 1 year: Implant retained


Full range/weight bearing
Case 2: Infected femur mega-prosthesis

45-year-old female, pre-morbidly well


2010: Ewing’s Sarcoma of left femur diagnosed
- Resection and replacement of proximal femur
+ Chemotherapy
+ Radiation 60 Greys
Case 2: Infected femur mega-prosthesis

45-year-old female, pre-morbidly well


2010: Ewing’s Sarcoma of left femur diagnosed
- Resection and replacement of proximal femur
+ Chemotherapy
+ Radiation 60 Greys

2014: Hip dislocation


- proximal implant removed
- Conversion to total hip arthroplasty
- Post-op: superficial skin infection
2014
Case 2: Infected femur mega-prosthesis

45-year-old female, pre-morbidly well


2010: Ewing’s Sarcoma of left femur diagnosed
- Resection and replacement of proximal femur
+ Chemotherapy
+ Radiation 60 Greys

2014: Hip dislocation


- proximal implant removed
- Conversion to total hip arthroplasty
- Post-op: superficial skin infection
2014: Hip arthroplasty

2015: Progression of infection → Implant communicating with


thigh wound
- 2019: femur osteomyelitis 2019: distal femur osteomyelitis
Case 2: Infected femur mega-prosthesis
Purulent discharge Walled-off abscess cavity
2019 2020

Defaulted
follow-up

On presentation: chronically discharging sinus, declined surgery


- Six months later: infection worsening, sepsis
- Drainage of abscess performed
Case 2: Infected femur mega-prosthesis
- MRI: infected implant with hip abscess, femur OM
2020

On presentation: chronically discharging sinus, declined surgery


- Six months later: infection worsening, sepsis
- Drainage of abscess performed
- MRI confirms abscess collection at proximal femur
Case 2: Infected femur mega-prosthesis
– Removal and antibiotic-infused cement spacer
Exposed infected implant

Mega-implant
removed

On presentation: chronically discharging sinus, declined surgery


- Six months later: infection worsening, sepsis
- Drainage of abscess performed
- MRI confirms abscess collection at proximal femur
- Agreeable for surgery in view of sepsis and metastatic focus in lungs, need to start chemotherapy
Case 2: Infected femur mega-prosthesis
– Removal and antibiotic-infused cement spacer
Exposed infected implant Multiple debridement + NPWTi-d

NPWTi-d
After removal of mega-prosthesis:
- Application of vancomycin-infused cement spacer
- Multiple surgical debridement
- Veraflo (NPWTi-d) with hypochlorous acid solution for 6 weeks
- Gradual closure of wound
Case 2: Infected femur mega-prosthesis
- Closure with NPWT: wound healed over spacer
Application of NPWTi-d over spacer

NPWTi-d
3 weeks

Wound completely
closed (3 week)
After removal of mega-prosthesis:
- Application of vancomycin-infused cement spacer
- Multiple surgical debridement
- Veraflo (NPWTi-d) with hypochlorous acid solution for 6 weeks
- Gradual closure of wound
Case 2: Infected femur mega-prosthesis
- Two-stage replacement

Total femur implant Tibial implant Infected distal femur


Case 2: Infected femur mega-prosthesis
- Two-stage replacement + flap coverage

Post-total femur implant: skin over lateral thigh chronically inflamed and previously irradiated
- Soft tissue deficiency especially proximal thigh due to previous wide resection
- Local flap coverage for vascularized tissue coverage over radiated tissue, Delivery of antibiotics
into cavity (rectus muscle), Allowance for ambulation, range of movement
Case 2: Infected femur mega-prosthesis
- 3 months later: repeat prosthesis with Flap closure: VRAM
Case 2: Infected femur mega-prosthesis
Post-reconstruction: 5 months (NPWTi-d: 3 weeks)

Removal of implant
NPWTi-d x 3 weeks Rectus abdominis muscle Ambulating with aid
Case 3: Trauma related orthopedic implant
- Open degloving foot injury + Exposed hardware
• 24-year-old motorcyclist
• Collision with car, right foot run
over by car
• Multiple metatarsal open fractures
• Bone Loss
• Large surface area skin loss
• K-wire fixation and repair of
extensor tendons
Case 3: Trauma related orthopedic implant
- Open degloving foot injury + Exposed hardware
• Superficial circumflex iliac perforator flap
harvested from left groin

• Environmental biological contamination with


multiple pathogens on culture

• Veraflo Therapy with hypochlorous acid


(HOCl) x 2 weeks
Case 3: Trauma related orthopedic implant
- Open degloving foot injury + Exposed hardware
• After one year:
• Hair bearing area:
• - Good match
with contralateral foot
• Reduced wound
tension from
ActiV.A.C. Therapy
System:
• -Acceptable scar
Case 4: Infected Orthopedic Implant
- Multiple plate exposure with bone loss
• 35-year-old female
• Attempted suicide: fell down3
stories:
- Open fracture, ORIF
- Bone loss and infection
- Large 5 cm bone bone gap
- Bone cement applied

• NPWTi-d 3 weeks
• Systemic antibiotics
• Multiple debridement
• Skin defect
• Bone Defect

Plan: Flap coverage


Case 4: Infected Orthopedic Implant
- Multiple plate exposure with bone loss
After Veraflo Therapy x 3 weeks:
- Irrigation with HOCl
- Multiple surgical debridement
- Negative tissue culture
- Wound clean

Artery: retrograde ETE

Vein: side branch


Case 4: Infected Orthopedic Implant
- Masquelet technique
• 6 months later:
• Bone cement removed and iliac-
crest bone graft applied

After 1 year Flap raised to access cement Bone graft applied


Case 5: Failed salvage of Infected Knee Arthroplasty
- Initial salvage: NPWTi-d x 3 weeks

Infected Knee Implant Pedicled ALT Flap Rotation 180 degrees


Unfit for GA
73-year-old female, diabetic, ischemic heart disease with right heart failure
- Knee replacement 3 years prior to presentation
- Small festering wound → large defect at patella
- Implant deemed clean, referred for coverage
- NPWTi-d x 6 weeks
Case 5: Failed salvage of Infected Knee Arthroplasty
- Flap tip failure

Flap Tip Necrosis, Infection with pseudomonas Debridement:Exposure of Tissue and Implant

Flap tip necrosis:


- Failed coverage resulting in exposed wound and implant
- NPWTi-d x 4 weeks more
Case 5: Failed salvage of Infected Knee Arthroplasty
- Flap tip failure → NPWTi-d x 4 weeks more

Veraflo Therapy x 4 weeks (NaOCl) After 4 weeks


Case 5: Failed salvage of Infected Knee Arthroplasty
- Successful salvage and coverage of wound (NPWTi-d 10 wks)

2 months
NPWT x 7 days with SSG (75mmHg)
Single skin graft procedure under LA
Case 5: Failed salvage of Infected Knee Arthroplasty
- Flap tip failure
Total NPWTi–d: 10 weeks
Case 5: Failed salvage of Infected Knee Arthroplasty
- 1 year later: infrapatellar abscess

Infrapatella abscess Extension into implant Implant removed


Case 5: Failed salvage of Infected Knee Arthroplasty
- Removal of implant + NPWTi-d x 5 weeks + hemisoleus

Joint cavity Cement Spacer Hemisoleus flap


NPWTi-d x 5 weeks and iodine instillation
Case 5: Failed salvage of Infected Knee Arthroplasty
- Total coverage of spacer

Muscle flap coverage Skin graft after 1 week+ NPWT i-d 6 months
Case 5: Failed salvage of Infected Knee Arthroplasty
- Long-stem revision of TKR: healed well (1 year)
Case 6: Hallux Valgus with infected implant

78-year-old female, hypertension


- Severe hallux valgus
- Correction with osteotomy and plate fixation
- Wound broke down after 3 weeks → implant exposed despite debridement and closure
- NPWT i-d x 6 weeks, hyperbaric oxygen
Case 6: Hallux Valgus with infected implant

Before angioplasty After angioplasty


78-year-old female, hypertension
- Wound broke down after 3 weeks → implant exposed despite debridement and closure
- NPWTi-d x 6 weeks, hyperbaric oxygen
- Angioplasty done
Case 6: Hallux Valgus with infected implant

Before angioplasty After angioplasty


78-year-old female, hypertension
- Wound broke down after 3 weeks → implant exposed despite debridement and closure
- NPWTi-d x 6 weeks, hyperbaric oxygen
- Angioplasty done
How Do We Make NPWT Work For Us?
Wound bed preparation Surgical Preparation
• Debridement of devitalized tissue • Curettage of wound bed
• Deep tissue cultures for anaerobic and aerobic • Irrigation with antiseptic and saline
bacteria • Hemostasis
• Preparation of surrounding skin • Excisional debridement of necrotic/infected
tissue
Host factor control
• Immobilization Post-surgical care
• Smoking, Vascularity • Elevation to reduce exudate
• Nutritional Status • Pain relief
• Control blood sugar, hypertension • Regular inspection
• Antiseptic choice
• Pressure and Intensity settings
Veraflo Therapy: Instillation Choices for Infected Implant
Wounds

Acetic Acid Octenidine HCL Chlorhexidine

Polyhexamethylene Biguanide
Hypochlorous solution Povidone-Iodine (PHMB)
V.A.C. Veraflo Dressing Choices
V.A.C. Veraflo Dressing Choices
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What is the Best Antiseptic for NPWTi-d?

Kramer et al. Consensus on Wound Antisepsis: Update 2018. kin Pharmacol Physiol . 2018;31(1):28-58.
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Clinical Evidence for NPWTi and Antiseptics

• NPWTi-d with saline


is significantly better
than NPWT alone
• NPWTi-d with
antiseptic is better
with antiseptic alone
• Significant bacterial
reduction with dilute
antiseptic

Kramer et al. Consensus on Wound Antisepsis: Update 2018. kin Pharmacol Physiol . 2018;31(1):28-58.

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Antiseptic Choice: NPWTi-d: Veraflo™ Therapy

Antiseptic Choice:
• Hypochlorous solution (NaOCl/HOCl) vs Octenidine (OCT) vs Prontosan (PHMB) vs Iodine
(PVP-I)

Kramer et al. Consensus on Wound Antisepsis: Update 2018. kin Pharmacol Physiol . 2018;31(1):28-58.

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Conclusion

• NPWTi-d has revolutionized treatment of infected orthopedic implant


• Increasing use of NPWTi-d has salvaged infected cases
• Previous tenet of implant removal upon infection is no longer always necessary
• Large implants still needs removal
• Choice of antiseptic is important
• Basic concepts of infection control still important:
• Wound bed preparation
• Antibiotics
• Change in liner
• Surgical wound debridement
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