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Pulsatile Lavage for Pressure Ulcer
Management in Spinal Cord Injury:
A Retrospective Clinical Safety Review
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Kath M. Bogie, DPhil; and Chester H. Ho, MD
Abstract
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Pressure ulcers are major complications of reduced mobility and/or sensation. Pulsatile lavage therapy delivers localized
hydrotherapy directly to the wound utilizing a pulsatile pressurized stream of normal saline. The purpose of this study was
to evaluate the clinical safety of pulsatile lavage therapy, provided daily at the bedside, in routine management of Stage
III and Stage IV pressure ulcers. Charts from 28 male patients with Stage III and Stage IV pressure ulcers and spinal cord
injury (SCI) or spinal cord disorders (SCD) were retrospectively reviewed for documentation of adverse events/safety
concerns. Mean therapy duration was 46 days (SD 37 days, range 6–152 days). Treatment was interrupted for 6 days in
one patient due to minor wound bleeding. No other adverse events, including backsplash injuries, were documented.
The results of this chart review suggest pulsatile lavage therapy can be administered at the patient’s bedside without
adverse events if appropriate protocols are followed. Additional research to confirm the efficacy and effectiveness of this
treatment modality in a broader subject population is warranted.
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Keywords: pressure ulcer, hydrotherapy, pelvic, clinical safety, spinal cord injury
Index: Ostomy Wound Management 2013;59(3):35–38
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Potential Conflicts of Interest: none disclosed
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ressure ulcers (PUs) remain a major medical complication for many individuals with reduced mobility and/
or sensation. Treatment costs for an individual PU can vary
greatly depending on factors such as prolonged hospitalization and surgery. A 2010 cost-analysis1 of 12 Canadian community dwelling individuals with spinal cord injury (SCI)
found an average monthly cost of $4,745 (the total cost per
PU was not defined). A 2010 retrospective chart review2 of inpatient (N = 19) costs associated with the care of Stage IV PUs
found average costs to be more than $120,000 per ulcer. PUs
are the main cause for readmission in the SCI and SCI disorders (SCI/D) population,3 leading to reduced independence
and decreased quality of life. In the general field of rehabilitation, it is well established that the development of a PU will
increase both medical costs and length of stay.4 Timely and
effective treatment of PUs is a central requirement for suc-
cessful care outcomes, and many different treatment options
are available. The National Pressure Ulcer Advisory Panel
(NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP)
Clinical Guidelines5 indicate only two specialized treatment
modalities can be recommended to enhance wound healing,
one of which is hydrotherapy. Hydrotherapy was previously
implemented as whirlpool therapy and has been found to be
effective in a case-controlled study design,6 where the control
group (n = 18) received conservative treatment alone (maximization of pressure relief and twice-daily wet-to-wet dressing with normal saline) and the intervention group (n = 24)
received conservative treatment plus whirlpool therapy for
20 minutes daily. Wound dimension measurement indicated
that wounds in the intervention group improved significantly faster than those in the control group. However, whirlpool
has become less popular due to its labor- and time-intensive
Dr. Bogie is a Senior Research Scientist and Assistant Professor, Advanced Platform Technology Center, a VA Research Center of Excellence, Louis Stokes
Cleveland Department of Veterans Affairs Medical Center; and Assistant Professor, Departments of Orthopedics and Biomedical Engineering, Case Western
Reserve University, Cleveland, OH. Dr. Ho is an Associate Professor and Head of the Division, Division of Physical Medicine and Rehabilitation, Department of
Clinical Neurosciences, Foothills Hospital, Calgary, Alberta, Canada; and at the time of manuscript preparation, Chief, SCI/D Service at the Spinal Cord Injury
Unit, Louis Stokes Cleveland Department of Veterans Affairs Medical Center. Please address correspondence to: Kath M. Bogie, DPhil, Louis Stokes Cleveland
VA Medical Center, APT Center of Excellence, 151 vAW/APTLSCDVAMC, 10701 East Boulevard, Cleveland, OH; email: kmb3@case.edu.
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Feature
Ostomy Wound Management 2013;59(3):35–38
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Key Points
• Historically, the use of hydrotherapy through whirlpool
treatments was recommended for the management of
a variety of chronic wounds, including pressure ulcers.
• Because cross-contamination is an important concern, hydrotherapy methods have been replaced by
the use of single-patient equipment to administer
pulsatile lavage.
• Clinical studies documenting the outcomes of this
treatment modality in pressure ulcers are limited;
safety concerns remain.
• Researchers did not find evidence of serious adverse
reactions in the charts of 28 patients who underwent
pulsatile lavage therapy for their Stage III and Stage
IV pressure ulcers.
• Additional safety studies, as well as evidence to support the efficacy and effectiveness of this treatment
modality, are warranted.
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mode of delivery combined with an unacceptable potential
for complications, as reported in two infection control studies.7,8 A case study9 reported bilateral amputations in a paraplegic patient due to hydrotherapy burns.
Pulsatile lavage therapy delivers localized hydrotherapy
directly to the wound area utilizing a pulsatile pressurized
stream of normal saline. The treatment is delivered through
a single-patient use device with a disposable tip. This technique has been used for many years for intra-operative joint
cleansing in the field of orthopedic surgery.10 A trained nurse
can administer pulsatile lavage. The use of pulsatile lavage
has been less widespread in the field of wound care and mostly focused on the debridement of necrotic wounds. In a double-blind study11 conducted among 28 persons with SCI/D,
the effects of pulsatile lavage were assessed in clinically clean
ulcers that did not require debridement. In this study, persons with SCD and a Stage III or Stage IV pelvic PU were
randomized to a treatment (n = 14) and a control group (n =
14) of dressing changes and maintenance of a moist wound
environment. Wound dimensions decreased more rapidly in
the pulsatile lavage group, leading to statistically significant
differences in healing rate between the treatment and control
groups for wound length and width (P <0.0001) and depth
and volume (P <0.001). Even though the clinical impression
of therapy recipients was that pulsatile lavage was a safe treatment modality, to date, a literature review has shown no published systematic review of the clinical safety aspects of this
treatment modality.
No adverse effects were seen in the previous study11;
however, a study12 of clinical practice at the Johns Hopkins
Hospital described an outbreak of multidrug-resistant Acinetobacter baumannii (MDR-Ab) associated with pulsatile
lavage wound treatment during inpatient hospitalization. An
outbreak, case-control investigation of seven patients identified as infected or colonized with MDR-Ab were compared
to 28 controls without MDR-Ab infection. It was suggested
that extensive environmental contamination occurred during pulsatile lavage, which led to transmission of a multi-resistant strain of Acinetobacter from patient to patient.
In addition to systemic infection or sepsis, patientcentered adverse event parameters that could occur due to
the biophysical nature of pulsatile lavage therapy should
be examined in order to determine clinical safety. Thus,
in addition to de novo wound infection as a result of the
therapy and presence of sepsis, potential adverse events that
could occur due to pulsatile lavage therapy include pain
and bleeding. Pulsatile lavage therapy is delivered directly
to the wound area with concurrent suction to remove the
contaminated lavage fluid. The concurrent application of
suction, albeit at a relatively low level, has the potential to
cause pain and/or bleeding.
Autonomic dysreflexia is a potentially serious outcome in
persons with SCI/D with a neurologic level of injury at or
above T6, secondary to unopposed sympathetic output of
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the autonomic nervous system when a noxious stimulus is
detected by the sensory system. It could lead to hypertensive
crisis, which could then result in myocardial infarction or
cerebrovascular accident.13,14
The purpose of this study was to evaluate the clinical safety of pulsatile lavage therapy in routine management of Stage
III and Stage IV PUs.
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Methods
A retrospective chart review was conducted of individuals with SCI/D who had pelvic region PUs treated by pulsatile lavage at the authors’ facility over the same time frame
as persons studied concurrently in a blinded clinical study.11
During the 3-week study, pulsatile lavage was administered
daily in the patient’s room, with the patient in his/her own
bed, for 10 to 20 minutes by trained nursing staff using the
Food and Drug Administration (FDA)-approved Stryker
Interpulse system (Stryker Instruments, Kalamazoo MI).
This system consists of a battery-powered pump device that
produces the water spray effect for the lavage. Pulsatile lavage therapy is delivered directly over the PU at a distance of
0.5–2 inches from the wound bed. The pump device provides
a water spray pressure of 11 lb per square inch (psi) — ie,
within the recommended low pressure range of 4–15 psi.5 A
1-L bag of sterile normal saline was used as the source of the
water spray, and the pump device was attached to it during
the lavage. The water spray was delivered through a detachable fan shower spray. Concurrently, water suction was provided at the tip of the fan spray. The shape of the fan spray
and the concurrent water suction ensured that contaminated
lavage fluid was immediately removed from the wound area
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Pulsatile lavage safety
Table 1. Pulsatile lavage treatment adverse event
outcomes abstracted
Measurement
Y/N
Development of systemic infection (sepsis)
Y/N
Pain
Y/N
Bleeding from the ulcer
Y/N
Presence of autonomic dysreflexia
Y/N
Discontinuation of treatment due to
adverse event
Y/N
A
Development of pressure ulcer infection
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Patient-centered
Clinician safety
Splash injury
Y/N
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and collected in a disposable canister, preventing accidental
splashing of the lavage fluid during the procedure. The system is single-patient use only, and a new lavage tip is used for
each treatment. Clinical personnel wore protective garments
and goggles while administering the treatment. Protective
drapes were placed on the bed and around the wound area.
Chart review procedure. The study protocol was deemed
exempt by the Louis Stokes Cleveland Department of Veterans Affairs Medical Center Institutional Review Board. In
addition to patient demographic and PU information, both
patient-centered and clinician safety variables were reviewed
and abstracted. Charts were initially reviewed for documentation of all adverse events during the time frame during
which pulsatile lavage treatment was administered; specifically, PU depth (stage), wound area, location, infection status, and presence/absence of necrotic tissue were abstracted.
A secondary detailed chart review then was performed to determine if the adverse event had any association with delivery
of pulsatile lavage treatment. For example, a report of autonomic dysreflexia during bowel care would initially be listed
as an adverse event, but on secondary review it would be determined it was unrelated to lavage therapy. Patient-centered
safety variables abstracted included development of PU-related infection, development of systemic infection (sepsis),
pain, bleeding from the ulcer, and/or presence of autonomic
dysreflexia using a yes/no notation (see Table 1). A clinical
safety review was carried out of adverse events occurring related to the therapeutic intervention for both the treatment
cohort and the clinicians providing pulsatile lavage therapy.
The occurrence of adverse events reported by the administering clinical provider, specifically splash injury, was abstracted
as a clinical safety variable.
A Quality Improvement nurse familiar with this patient
population and PU treatment completed the chart review.
Data collection. Data were extracted from the medical
chart in the computerized patient record system (CPRS) and
stored in a de-identified Excel spreadsheet.
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Parameter
Results
The treatment cohort comprised 28 men, several of whom
had multiple ulcers; a total of 38 Stage III and Stage IV pelvic region PUs were provided pulsatile lavage. Within this
cohort, 28 individuals had one, nine had two, and one had
three PUs, for which therapy was provided. Twelve patients
were tetraplegic and 17 were level A status per American Spinal Cord Injury Impairment Status (AIS) — ie, no motor or
sensory function is preserved in the sacral segments S4-S5
(see Table 2). The majority of PUs were in the sacral (47%) or
ischial (45%) regions. Mean pulsatile lavage therapy duration
was 46 days (SD 37 days, range 6–152 days). Treatment was
temporarily discontinued in one patient due to mild bleeding from the wound and resumed 6 days later without any
further problem. Treatment was discontinued in one patient
due to rapid improvement in the wound size and in another
due to a concurrent fever of unknown origin. No splash injury to any clinical care provider administering pulsatile lavage therapy was documented, and no other adverse events
or treatment discontinuations were documented.
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Discussion
Although whirlpool therapy is effective,6 its limitations for
PU care — especially the risk of cross-contamination — have
made clinical usage obsolete. Pulsatile lavage utilizes a singlepatient system and was found to be well-accepted when used
to treat Stage III and Stage IV PUs.11 Not only has the authors’
research previously shown that pulsatile lavage was clinically
efficacious, but it has also demonstrated that given the appropriate infection control precautions as described in the
current methodology, low-pressure pulsatile lavage is not associated with an increased rate of environmental contamination.15 The current study is first to report on the clinical safety
of pulsatile lavage and did not identify any serious patient- or
clinicial-related adverse events, such as splashing.
Although environmental contamination was not evaluated in this retrospective chart review, it is important to note
that a previous report of an outbreak among inpatients who
received pulsatile lavage therapy in clinical practice at the
Johns Hopkins Hospital was attributed by the authors mainly
to two practices that negatively affected infection control12:
the use of a common wound care treatment area for pulsatile
lavage and use of the same suction canister for all the patients.
A safe treatment protocol must incorporate infection control
practices, including single-patient use systems. In addition,
a new lavage tip is required for each treatment. Clinical personnel must wear personal protection equipment, including
protective garments and goggles, during delivery of pulsatile
lavage treatment, and the wound area must be draped. The
results of this chart review suggest that pulsatile lavage therapy can be administered at the patient’s bedside without adverse events if appropriate protocols are followed. Additional
research to confirm the safety and establish the efficacy and
effectiveness of this treatment modality is warranted.
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Feature
Table 2. Patient demographic characteristics
Level of injury
AIS status
a
a
Mean
55
Tetraplegic
12
A
17
SD
10
B
3
Minimum
37
Maximum
74
Paraplegic
12
MS
4
C
3
D
0
Four individuals had a primary diagnosis of multiple sclerosis; AIS = American Spinal Cord Injury Impairment Status
Sacral
18
Ischial
17
Stage (n)
III
8
IV
30
Size (n)a
<10 cm2
10
10 to <50 cm2 18
Pre-existing clinical wound Yes
infection (n)a
7
No
31
Pre-existing wound tissue
necrosis (n)a
13
No
25
5
3
50 to <100 cm2
7
>100 cm2
3
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a
Yes
Trochanteric
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Location (n)
A
Table 3: Pressure ulcer characteristics
N/A
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Age (years)
Surface area
References
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The average cost of pressure ulcer management in a community dwelling spinal cord injury population. Int Wound J. 2012;doi: 10.1111/j.1742481X.2012.01002.x. PMID: 22715990.
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cost of Stage IV pressure ulcers. Am J Surg. 2010(4):473–477.
3. Chen D, Apple DF Jr, Hudson LM, Bode R. Medical complications during
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ulcers, hospital complications, and disease severity: impact on hospital
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treatment of pressure ulcers: clinical practice guideline. Washington (DC):
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11. Ho CH, Bensitel T, Wang X, Bogie KM. Pulsatile lavage for the enhancement of pressure ulcer healing: a randomized controlled trial. Phys Ther.
2012;92(1):38–48.
12. Maragakis LL, Cosgrove SE, Song X, Kim D, Rosenbaum P, Ciesla N, et
al. An outbreak of multidrug-resistant Acinetobacter baumannii associated
with pulsatile lavage wound treatment. JAMA. 2004;292(24):3006–3011.
13. Dolinak D, Balraj E. Autonomic dysflexia and sudden death in people with
traumatic spinal cord injury. Am J Forensic Med Pathos. 2007;28(2):95–98.
14.Karlsson AK. Autonomic dysfunction in spinal cord injury: clinical presentation of symptoms and signs. Prog Brain Res. 2006;152:1–8.
15. Ho CH, Johnson T, Miklacic J, Donskey CJ. Is the use of pulsatile lavage for pressure ulcer management associated with environmental
contamination with Acinetobacter baumannii? Arch Phys Med Rehabil.
2009;90(10):1723–1726.
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Limitations
The most important limitation of this study is the retrospective design, which introduces risks of charting omissions,
errors, and clinician bias. In addition, the sample size was
small and treatment duration varied.
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Conclusion
Aretrospectivechart review was conducted to evaluate the
clinical safety of pulsatile lavage for the treatment of Stage III
and Stage IV PUs in individuals with SCI/D in routine clinical management. An interruption in treatment was documented for one of 28 patients due to minor wound bleeding.
No other adverse events, including autonomic dysreflexia
and splash injury, were recorded.
In this small study, pulsatile lavage provided a safe form
of hydrotherapy for the treatment of Stage III and Stage IV
pressure ulcers in persons with SCI/D. n
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Acknowledgments
The authors acknowledge the VA for indirect support
provided through access to VA resources. Identifiers were removed for blinding of reviewers. The authors are grateful to
Robin Blake, RN, MSN, DNP, CNS, who carried out the retrospective chart review.
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