Efficacy of Negative Pressure with Simultaneous Irrigation
in Treating Infected Wounds
Clinical Best Practices Track
Sandra J. Berriman, Ph.D.
Vice President, Clinical Affairs
Cardinal Health Wound Management
Pompano Beach, FL
Kathryn E. Davis, Ph.D.
Adjunct Assistant Professor
University of Texas, Southwestern
Dallas, TX
Disclosures
• The presenter has no financial relationships to disclose.
• This continuing education activity is managed and accredited by Professional
Education Services Group in cooperation with AMSUS.
• Neither PESG,AMSUS, nor any accrediting organization support or endorse any
product or service mentioned in this activity.
• PESG and AMSUS staff has no financial interest to disclose.
• Commercial support was not received for this activity.
Learning Objectives:
At the conclusion of this activity, the participant will be able to:
1. Understand the wound healing benefits of Negative Pressure Wound
Therapy
2. Understand the benefits of wound irrigation during NPWT
3. Understand the fluid dynamics of wound irrigation while applying Negative
Pressure
Efficacy of Negative Pressure with
Simultaneous Irrigation in Treating
Infected Wounds
Presentation Overview
Overview of Irrigation with Negative Pressure Wound Therapy (NPWT)
• Clinical Use of Negative Pressure
• Description of Intermittent and Simultaneous Irrigation
Simultaneous Irrigation with NPWT: Science
• Wound Bioburden
• Distribution of Irrigant Across the Wound Bed
Practical Application of Irrigation with NPWT
• Case Study Discussions
Summary and Conclusions
Clinical Steps Necessary to Promote Wound
Healing
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Maintain a moist wound environment (desiccation is toxic to wound healing)
Removal of necrotic and/or infected tissue
Manage edema
Ensure adequate local blood supply
Enhance:
• Wound contraction
• Granulation tissue formation
• Epithelialization
Negative Pressure: Mechanism of Action
Macro and Micro Tissue Deformation
• Cellular stretch stimulates cellular proliferation and inflammation
• Local perfusion
• Granulation tissue development
• Edema reduction
Why NPWT Alone Is Not Always Enough
Challenges with NPWT:
• Wounds are difficult to cleanse at time of dressing change
• Wound environments are often polymorphic
• Wounds are often suboptimal when you initiate NPWT
• Wounds may be highly colonized despite their appearance
• Removing foam from the wound may be painful
• Wounds can stall during the healing process
Benefits of NPWT with Irrigation
• Wound is cleansed of slough and
debris
• Reduction of bioburden
• Reduced pain at dressing change
• Moisture balance in wound bed
How Is Irrigation Delivered With NPWT
Simultaneous Irrigation
Intermittent Instillation
There are no studies -- bench top or clinical -- that compare simultaneous
irrigation versus instillation therapy using the appropriate devices
A Look At NPWT With Intermittent Instillation
• Set up requires a special foam dressing kit
• User determines and sets fluid volume needed to fill the wound with
irrigant
• Device instills irrigant solution while Negative Pressure is OFF
• User must determine dwell time of fluid instilled
• User must determine how often the cycle will be repeated
• Irrigant delivery port is the same as exudate exit port
Simultaneous Irrigation
• Requires one additional
SpeedConnect and irrigation bag
• Irrigant flows throughout the wound
without interrupting Negative
Pressure
• No special foam dressing kit required
• Set up takes less than 1 minute
• Irrigant travels anywhere that foam is
placed in the wound
• Separate ports prevent contamination
Simultaneous Irrigation continued
• Can use very low flow rates
• Does not require calculation of fill volumes or additional
programming of the device
• Never sacrifice negative pressure for wound irrigation
• Negative pressure is maintained at all times and therefore can help
maintain dressing seal integrity
NPWT
IRRIGATION
Irrigation Solution Options
Possible Solutions to be used as Irrigation
Hypochlorite-based solutions (eg. Hypochlorous acid, Sodium
Hypochlorite Dakin's Solutions (0.25 or 0.50 strength), Dermacyn,
Microcyn
No device-related considerations
Silver nitrate (0.5%)
Silver nitrate is light sensitive
Sulfur-based solutions (Sulfonamides) Mafenide acetate
Contraindicated in sulfa allergies
Biguanides (Polyhexanide) Prontosan
Cationic solutions (Odenidine, Benzalkonium Chloride Odenilin,
Zephiran)
Isotonic Saline, Lactated Ringers
Antibiotic solutions: Doxycycline
No device-related considerations
Acetic Acid (0.025%)
No device-related considerations
No device-related considerations
No device-related considerations
No device-related considerations
Innovative Therapies Clinical Guidelines for Simultaneous Irrigation,
Development of NPWT with Simultaneous
Irrigation
Dr Pal Svedman, MD, PhD
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•
•
•
•
•
Swedish Plastic & Reconstructive Surgeon/ Professor
of Medicine at Lund University.
First physician/inventor to propose combining
Negative Pressure Wound Therapy (NPWT) with
Simultaneous Irrigation.
Began experiments with NPWT & irrigation in 1976
Papers published in IRSC Medical Science, Scan J.
Plastic Reconstructive Surgery, and the Lancet in the
late 1970s.
Key patent - 4,382,441, issued in 1983.
First products put into clinical use in the early 1980’s.
Dr Pal Svedman, MD, PhD
“Two-Port Irrigation Dressing”
Svedman, et al. Fluid Supply and Suction Drainage Used for Continuous or Intermittent Irrigation. Ann Plastic Surg 17(2):125-133, 1986.
NPWT and Simultaneous
Irrigation: Science
Controlled Trials of Irrigation Therapy
• There are few published reports on the use of Instillation Therapy
• Case Series
• Retrospective Analyses
• No prospective randomized clinical trails have been published using either
method of irrigation therapy
• The efficacy parameters for irrigation therapy have yet to be determined and are
actively being studied
Gabriel, A., et al.,. Int Wound J, 2008. 5(3): p. 399-413.
Timmers, M.S., et al., Wound Repair Regen, 2009. 17(2): p. 278-86.
Schintler, M.V.P., E. C.; Kreuzwirt, G.; Grohmann, M. R.; Spendel, S.; Scharnagl, E. ,Infection
2009 Vol. 37 No. Supplement 1 pp. 31-36 2009. Raad, W., et al., Int Wound J, 2010. 7(2): p.
81-5.
NPWT With Polyvinyl Alcohol Foam and Polyhexanide
Antiseptic Solution Instillation in Posttraumatic Osteomyelitis.
A retrospective, cohort study of 30
patients diagnosed with
osteomyelitis of the pelvis or
lower extremity
Control patients (n=94) received
standard care
Instillation solution was
polyhexanide.
Irrigation 10-15 minutes
300 mmHg to 600 mmHg negative
pressure (wall suction)
Mean duration of therapy was
19.0-22.4 days
Fewer Infection 10% vs. 58.5%
p<0.0001.
Shorter hospital stay shorter 36 vs
73 days
Fewer surgical procedures 2 vs 5
(p<0.0001)
Timmers, M.S., et al., Wound Repair Regen, 2009. 17(2): p. 278-86.
The Impact of NPWT with Instillation
Compared to NPWT: A Retrospective Study
NPWT
N=74
NPWTi
N=34
6 min
OR VISITS
3.0 ± 0.9
LENGTH OF STAY
TIME TO FINAL SURGICAL
PROC
PRECENT CLOSED
QUAL CULTURE
IMPROVEMENT
QUAL CULT IMP IF
Exclude GN, C, Y
p Value
NPWTi
N=34
20 min
p Value
2.4 ± 0.9
0.04
2.6±0.9
0.003
14.9 ± 9.2
11.9 ± 7.8
0.10
11.4 ±5.1
0.03
9.23 ± 5.2
7. 8 ± 5.2
0.04
7.5 ±3.1
0.002
62%
94%
0.001
80%
0.08
38%
59%
0.06
50%
0.30
63%
90%
0.0001
65%
0.77
Science of Simultaneous Irrigation
Novel Delivery of Established Therapies
Choice of Irrigation Solution
• Coupled with NPWT, irrigation therapy allows for administration of fluids
including antiseptics, antibiotics, or drugs
• There are a number of solutions that may be appropriate for use
• Animal studies report contradictory findings regarding the wound healing
effectiveness of various irrigation solutions
• There are no data to date that indicate optimum
• Irrigation solution
• Rate of infusion
Anna Drosou, MD, Anna Falabella, MD, Robert S. Kirsner, MD Antiseptics on Wounds: An Area of Controversy Wounds. 2003;15(5)
Testing Therapies in a Porcine Model
Davis K, Bills J, Barker J, Kim P, Lavery L. Simultaneous irrigation and negative pressure wound therapy
enhances wound healing and reduces wound bioburden in a porcine model. Wound Repair Regen. 2013 Vol
21(6):869-875.
Preclinical Trial: “The Davis Bioburden Study”
Objectives
• To determine if the NPWT with
and without Simultaneous
Irrigation accelerates wound
healing
• To determine if simultaneous
irrigation with Saline or the
antimicrobial, Prontosan,
reduces wound bioburden
Control
NPWT
Saline Low
~500 CFU
Saline High
Pront Low
Pront High
3 days
Davis K, Bills J, Barker J, Kim P, Lavery L. Simultaneous irrigation and negative pressure wound therapy
enhances wound healing and reduces wound bioburden in a porcine model. Wound Repair Regen. 2013 Vol
21(6):869-875.
Wound Healing and Bioburden Study:
Methods
EXPERIMENTAL DESIGN:
• 21 days of therapy
• Dressing changes 2x/week
• Monitored every 12 hours
• Canister volume
• Infusion bag volume
• Patch integrity
• Pump alarms etc
STUDY ENDPOINTS:
• Wound Healing Rates
• Bacterial Analysis at each
dressing change utilizing
qPCR
• Normal Saline versus
Prontosan
• Fast versus Slow
Irrigation Rates
Davis K, Bills J, Barker J, Kim P, Lavery L. Simultaneous irrigation and negative pressure wound therapy
enhances wound healing and reduces wound bioburden in a porcine model. Wound Repair Regen. 2013 Vol
21(6):869-875.
Daily Infusion Volumes
Daily Infusion Volume
Volume (cc)
1500
41cc
38cc
Low flow = 5-15cc/hr
High flow = 30-40cc/hr
1000
15cc
12cc
500
0cc
0cc
0
i
T
T
o
o
Hi
H
L
L
N
W
l
l
Sa HMB
CO
MB
NP
Sa
H
P
P
Davis K, Bills J, Barker J, Kim P, Lavery L. Simultaneous irrigation and negative pressure wound therapy
enhances wound healing and reduces wound bioburden in a porcine model. Wound Repair Regen. 2013 Vol
21(6):869-875.
NPWT With or Without Irrigation Reduces
Wound Area
Wound Closure
Cont
NPWT
Sal Lo
Sal Hi
PHMB Lo
PHMB Hi
Wound Area % Day 0
150
*
*
100
*
*
*
50
0
0
5
10
15
*
20
25
Time (days)
Davis K, Bills J, Barker J, Kim P, Lavery L. Simultaneous irrigation and negative pressure wound therapy
enhances wound healing and reduces wound bioburden in a porcine model. Wound Repair Regen. 2013 Vol
21(6):869-875.
Simultaneous Irrigation with both Saline and
Prontosan Significantly Reduces Bioburden over
NPWT Alone or Control
% of Day 0
Pseudomonas
8×107
7×107
6×107
5×107
4×107
8000
*
6000
4000
*
p=0.068
*#
2000
0
n
o
C
t
N
T
PW
*#
*#
i
o
H
Hi
L
Lo
l
l
S a HM B
MB
Sa
H
P
P
Davis K, Bills J, Barker J, Kim P, Lavery L. Simultaneous irrigation and negative pressure wound therapy
enhances wound healing and reduces wound bioburden in a porcine model. Wound Repair Regen. 2013 Vol
21(6):869-875.
Conclusions
• In an acute wound healing model:
• Both NPWT alone and NPWT with simultaneous irrigation reduced wound
volume
• NPWT reduces bioburden (measured by qPCR) compared with control
therapy
• Simultaneous irrigation, whether with saline or the antimicrobial, Prontosan,
significantly reduces bioburden over NPWT and control dressings alone
• Improvement in bioburden does not correlate with accelerated wound
healing over NPWT alone in a porcine model
• The effects of irrigation therapy may be more likely to be correlated with
wound healing in a clinical setting
How is Irrigation Distributed
Across the Wound Bed
Fluid Dynamics of Simultaneous Irrigation
• 3-dimensional wound models were created using clear ballistic gel
• Distribution of fluid across the wound beds was assessed using simultaneous
irrigation visualized in real time.
• The fluid dynamics of simultaneous irrigation was observed in simple and
complex wound models.
• Displacement of fluid was visualized during continuous irrigation
Clear synthetic ballistic gel (Clear Ballistics, Fort Smith, Arkansas).
Davis KE, Moquin KJ, Lavery LA. The fluid dynamics of simultaneous irrigation with negative
pressure wound therapy. Int Wound J. 2015 May 12. doi: 10.1111/iwj.12456. PMID: 25968404
Experimental Model
Davis KE, Moquin KJ, Lavery LA. The fluid dynamics of simultaneous irrigation with negative
pressure wound therapy. Int Wound J. 2015 May 12. doi: 10.1111/iwj.12456. PMID: 25968404
Experimental Model
• Wounds (3) were carved at varying areas, depths and volumes into the ballistic gel with
varying characteristics
• Hydrophilic white polyurethane foam was applied against the wound bed to allow
visualization of the irrigation solution. Wounds were then dressed with black
polyurethane foam
• Wounds were covered with drape and speed connects placed on the dressing and
connected to the NPWT device and irrigation fluid bag
Davis KE, Moquin KJ, Lavery LA. The fluid dynamics of simultaneous irrigation with negative
pressure wound therapy. Int Wound J. 2015 May 12. doi: 10.1111/iwj.12456. PMID: 25968404
Simultaneous Irrigation is Effective in Distributing
Solution to all Parts of the Wound Bed
Davis KE, Moquin KJ, Lavery LA. The fluid dynamics of simultaneous irrigation with negative
pressure wound therapy. Int Wound J. 2015 May 12. doi: 10.1111/iwj.12456. PMID: 25968404
Bridged 3-Dimensional
Wound Model
Simultaneous irrigation
effectively distributes the
irrigation solution throughout the
wound bed of bridged wounds.
Davis KE, Moquin KJ, Lavery LA. The fluid dynamics of simultaneous irrigation with negative
pressure wound therapy. Int Wound J. 2015 May 12. doi: 10.1111/iwj.12456. PMID: 25968404
Complex 3-Dimensional Wound Model
Undermining
Tunneling
Tunneling
Undermining
Davis KE, Moquin KJ, Lavery LA. The fluid dynamics of simultaneous irrigation with negative
pressure wound therapy. Int Wound J. 2015 May 12. doi: 10.1111/iwj.12456. PMID: 25968404
Displacement of
Irrigation Solution
Irrigation fluid moves
continuously across the
wound bed
Davis KE, Moquin KJ, Lavery LA. The fluid dynamics of simultaneous irrigation with negative
pressure wound therapy. Int Wound J. 2015 May 12. doi: 10.1111/iwj.12456. PMID: 25968404
NPWT with Simultaneous
Irrigation: Case Studies
Chronic Wound – Skin Graft Donor Site Treated with
NPWT and Simultaneous Irrigation with Saline
• 64 year old female with history of craniotomy requiring flap closure and skin
grafting.
• Thigh skin graft donor site failed to heal after 8 months of multi-modal therapy.
• Following 7 days of NPWT with simultaneous irrigation, donor site wound
initiated healing
NPWT and Necrotizing Fasciitis
• 32 year old otherwise healthy male, presented with necrotizing fasciitis of the left lower
extremity
• In addition to growing group A streptococcus, he also grew MDR Acinetobacter bumanii
• Large open wound led to severe hyponatremia
Simultaneous Irrigation Applied . . . .
• Following placement of pig skin on upper third and skin graft on lower two-thirds
• White hydrophilic foam was placed as contact layer followed by black hydrophobic foam
• Simultaneous irrigation with acetic acid (0.25) was initiated on entire graft site for 7 days
7 Days Post Simultaneous Irrigation Bolstering
...
35 Days Post Simultaneous Irrigation
Bolstering . . .
Final Skin Grafting with Negative Pressure
Alone as Graft and Donor Site Bolster
Healthy Skin Graft Appearance Following
NPWT Bolster Removal
Complete Wound Closure
Necrotizing Fasciitis Case: Scrotal Graft Before
and After Quantum with Simultaneous Irrigation
43 year old male, with history of uncontrolled diabetes who experienced one
week of pain, swelling, and drainage from his perineum.
Summary and Conclusions
• NPWT is one of the well-accepted standard advanced wound healing
methodologies
• The Davis study showed that both NPWT and NPWT with simultaneous irrigation
enhances wound healing over control therapy. In addition, NPWT with
simultaneous irrigation reduces wound bioburden over NPWT
• Simultaneous irrigation with saline is as effective as the antimicrobial, Prontosan,
in reducing wound bacteria
• Fluid dynamics studies with 3-D wound models demonstrate that simultaneous
irrigation delivered with NPWT reaches all areas of the wound bed and
continually exchanges irrigation solution
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