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Jacqui Laney, Justin Roake, David R Lewis
Topical negative pressure (TNP) is also known as vacuum
assisted closure (VAC), sub-atmospheric pressure dressing (SPD), vacuum sealing
technique (VST), foam suction dressing, sealed surface wound suction (SSS),
vacuum pack therapy, and sealing aspirative
therapy.1–3 It is the application of a
local sub-atmospheric pressure across a wound.4
TNP is used both as primary treatment of chronic and complex
wounds; and as an adjunct for temporary closure and wound bed preparation before
definitive surgical procedures—e.g. wound bed preparation pre skin
grafts.4,5 TNP has been recommended for a
variety of acute and chronic wounds including pressure wounds, diabetic leg
ulcers, lower leg wounds, traumatic wounds, burns, infected wounds, necrotizing
fasciitis, infected sternal wounds, and after skin
grafting.1,3,6
TNP therapy does not replace surgical wound debridement,
measures to improve blood circulation, or relevant treatment of
infection.6 TNP may also be useful to stabilise
wounds in patients not well enough to be considered for
surgery.4,5
It has been proposed that TNP promotes wound healing through
a number of mechanisms. These include oedema reduction, increased wound/dermal
perfusion, increased granulation tissue stimulation, decreased bacterial loading
and enhanced wound exudate
removal.2–5,7,8
A recent meta-analysis concluded that only increase in blood
flow appears to be proven, whereas the actual mode of action of TNP still
remains unclear.4,5,9 There is still a paucity
of data on optimal duration of TNP, however it seems to have its greatest effect
in the early stage of wound healing.5
Complications associated with TNP include decreased
mobility, pain, pressure necrosis, haemorrhage, haematoma, infection, and toxic
shock.1–4,7 Topical negative pressure is
contraindicated where there is necrotic tissue or eschar. The therapy should not
be placed directly over exposed organs or blood vessels, untreated
osteomyelitis, non-enteric or unexplored fistulas or malignancy in the
wound.1–4 TNP should be used with caution
in patients with difficult wound haemostasis, with active bleeding or taking
anticoagulants.1–4
The clinical evidence supporting the use of TNP has been
largely based on clinical perception, case series, small cohort studies and
weakly powered RCT’s, constituting a large amount of low level
evidence.10 Most published studies on TNP are
poorly designed and therefore its use in surgical practice remains
controversial. In 2006, an updated Health Technology Policy Assessment regarding
TNP was published from Canada.1 The assessment
reviewed seven international health technology assessments on TNP and found that
TNP was consistently reported as being helpful for healing a variety of wounds.
However, the effectiveness of TNP could not be quantified because of the poor
methodological quality of studies.1
Two recently published systematic reviews concluded that
there remains a lack of clinical evidence to support the use of TNP over more
conventional treatments.6,7 Despite this, the
use of TNP has increased substantially for treating a variety of clinical
scenarios. It has been suggested that because TNP is readily available and easy
to administer compared with multiple daily conventional dressing changes, it has
the potential to be used
inappropriately.1
The aim of this audit was to establish current opinion
regarding TNP from vascular surgeons practicing in New Zealand.
MethodVascular surgeons currently practicing in New Zealand
were identified using the Vascular Society of New Zealand (VSNZ) database. A
questionnaire was emailed to identified surgeons asking how often and how
successful the surgeons felt that TNP was in a variety of common clinical
situations (i.e. arterial ulcers (after revascularisation); venous ulcers; mixed
arterial/venous ulcers; following debridement of the ‘diabetic (Db)
foot’; lower limb (LL) surgical wound infections/dehiscences; and
lymphocoeles/seromas/lymph fistulas not treated successfully with conservative
management).
The responses were graded for use of TNP as always,
often, sometimes or never; and success was graded as very good, good, average,
poor or none. Surgeons were also asked if they used or recommended TNP in their
vascular surgical practice and whether or not they considered themselves
‘up to date’ regarding published evidence for TNP.
A week later, a second email was sent to non-responders
asking them to complete and return the questionnaire. Finally, a week later, a
third reminder was sent by post with an enclosed postage paid, self addressed
envelope asking surgeons to send their response back.
If email addresses were not available surgeons were
sent a hard copy of the questionnaire by post in the first instance.
ResultsThirty-nine vascular surgeons are registered on the VSNZ
database, however this included one radiologist who was excluded from the
current audit (therefore n=38); 34 surgeons responded (response rate of 89.5%).
The median response time was 3.38 days (range 12 min–11.8 days); 16
(47.1%) responded to the initial email, 8 (23.5%) to the second reminder, and 10
(29.4%) to the third. Of those surgeons who responded, 47% replied
electronically and 53% replied on paper.
Twenty-eight (82%) vascular surgeons in NZ used TNP in their
clinical practice, however only 17 (50%) considered themselves up to date
regarding published evidence for TNP. Eight surgeons (23.5%) considered that
they were not up to date with the evidence and 9 (26%) were not sure whether or
not they were up to date. Six (18%) surgeons did not use TNP in their
vascular surgical practice.
The use of TNPWT for different wounds is presented in
Figures 1 and 2, and Table 1.
Figure 1. How often TNP is used in above
clinical situations by New Zealand vascular surgeons
1=arterial ulcers;
2=venous ulcers; 3=mixed arterial/venous
ulcers; 4=following debridement of the diabetic foot;
5=lower limb surgical wound infections/dehiscences;
6=lymphocoeles/seromas/lymph fistulas not successfully managed
conservatively.
Figure 2. How successful TNP is considered when
used in various clinical situations by New Zealand vascular
surgeons
![]() 1=arterial ulcers;
2=venous ulcers; 3=mixed arterial/venous
ulcers; 4=following debridement of the diabetic foot;
5=lower limb surgical wound infections/dehiscences;
6=lymphocoeles/seromas/lymph fistulas not successfully managed
conservatively.
Surgeons were invited to submit any relevant comments with
their responses. Three surgeons not using TNP were limited by its availability
in their institutions. One surgeon commented that he sees little point in using
TNP, particularly if an ulcer is treated by good compression. Regarding
persistent lymphatic leakage, one surgeon thought that there was some logic in
using TNP, although in this situation he felt that patients often do not present
to a hospital setting.
DiscussionA chronic wound is defined as a wound that does not heal in
an orderly set of stages and in a predictable amount of time the way most wounds
do; wounds that do not heal within three months are often considered
chronic.11 The vast majority of chronic wounds
can be classified into three categories: venous ulcers, diabetic wounds, and
pressure ulcers.12,13
Management of chronic wounds remains costly and challenging
to health practitioners. They can also impose significant emotional and physical
stress to patients. Topical Negative Pressure (TNP) is becoming widely accepted
as a first line treatment in the management of a variety of wounds. Negative
pressure has been used as part of the treatment of wounds in the form of various
drains since the 1940’s.6 Its use in
encouraging healing of open surgical wounds, diabetic foot ulcers and chronic
non-healing wounds has been widely studied. Unfortunately most published studies
on TNP are poorly designed and therefore recommendations for its use in surgical
practice remain controversial—both clinically and economically.
A systematic review of topical negative pressure therapy for
acute (split skin grafts, diabetic foot amputation) and chronic (venous,
arterial, diabetic or pressure) wounds was recently
published.7 Fifteen relevant publications of
thirteen RCT’s evaluating effectiveness of TNP for patients with chronic
wounds, diabetic wounds, pressure ulcers, skin grafts and acute wounds were
included.
The authors concluded that these studies contained no
aggregate evidence for more relevant wound healing for any type of wound when
using TNP and that TNP should not routinely be promoted for use in local wound
care.7 The authors also emphasised the flaws
seen with the study designs including invitations for selection bias,
insufficient follow up periods and use of surrogate (yet clinically irrelevant)
endpoints, differing endpoints between studies and differing control treatments
meaning meta-analysis could not be performed.7
Individual trials suggested that chronic and diabetic wounds
treated with TNP appeared to be ready for secondary closure surgery between one
to ten days earlier, however this came at a cost of increased complications
(including two cases of sepsis in the TNP group). The authors of the review also
argued that ten days difference is negligible given that the nature of these
wounds often means that they take many months to
heal.7
In another systematic review published the same
year, the authors considered the effectiveness
and safety of negative pressure wound therapy (NPWT) for problematic wounds
including pressure wounds, post-traumatic wounds, diabetic foot ulcers and
miscellaneous chronic ulcers.6
Of the fourteen RCTs reviewed, twelve were included in the
systematic review discussed above,7 plus an
additional two part study.14 The authors
reported that the methodological quality was poor in most studies and that only
two trials were considered to have good internal
validity.6 Despite the poor methodological
quality of most papers the authors suggested that tentative evidence suggests
that NPWT appears to be at least as effective, if not more effective, than other
available local wound treatments.6
The most promising results were obtained in patients with
lower leg vascular ulcers, diabetic foot ulcers and split thickness skin
grafting.6 The main adverse events when using
TNP appeared to be infection, irritation of the skin and pain when changing the
dressing, however these were reported as mild and overall TNP appears to have an
acceptable safety profile.6
Two studies included in the review attempted to calculate
costs between TNPWT and alternative modern wound care products, one of which
found no difference between therapies.15 The
other calculated that TNPWT was less costly than that of the reference therapy,
US$3381 compared with $5452,15,16 however the
extent to which the equipment outlay was taken into consideration was unclear in
the cost analysis.6
Theoretically TNP may become more cost effective as less
expensive newer technology emerges. Faster healing times may result in shorter
hospital stays and less demand on health care systems. As there is a longer time
between dressing changes with TNP, there is less demand on nursing staff.
Braakenburg (2006) suggested that although overall costs between TNP and
traditional wound therapy were similar, TNP resulted in improved patient comfort
and decreased time and cost of nursing
staff.15
The systematic reviews concluded that the lack of
well-designed RCT’s evaluating the efficacy of TNP, means that no firm
findings can be drawn from them.6-7 Individual
papers tended to present more favourable findings.
Armstrong et al investigated TNP for its use in acute wounds
following diabetic foot amputation.10 Ubbink et
al. argued that although there was a 17% earlier wound healing time (number
needed to treat was six), there was an 11% higher infection rate (number needed
to harm was nine) in the TNP group.7 Armstrong
et al reported that none of these infections were treatment
related.6,10
A large multicentre randomised controlled trial enrolled 342
patients to evaluate the safety and clinical efficacy of negative pressure wound
therapy (NPWT), compared with advanced moist wound therapy (AMWT), to treat foot
ulcers in diabetic patients.17 They concluded
that a greater percentage of foot ulcers achieved complete wound closure with
NPWT (43%) compared with AMWT (29%) within the 112 day active treatment
period.17
Significantly fewer secondary amputations were required in
the NPWT group whilst there was no significant difference observed at 6 months
between the two groups in treatment related
complications.17 NPWT appears to be as safe and
more efficacious than AMWT for treating diabetic foot
ulcers.17
It has been documented that TNP leads to a significant
improvement in the wound management of recalcitrant chronic lower limb ulcers
(venous, mixed and arterial) that require skin graft
operations.16 Despite increased success of skin
grafting in patients using TNP, there was no difference in ulcer recurrence
rates.16 The number of patients recruited in
this study was too small to enable a sub group analyses for different types of
chronic leg ulcer.
McCallon had earlier reported that TNP is useful for large
venous ulcers, but arguably had no impact on arterial ulcers and those with
persistent arterial deficiency and persistent local
ischaemia.18 Experimentally, TNP results in no
improvement in micro-circulation in ischaemic human lower
limbs.19
In the current audit, vascular surgeons in New Zealand used
TNP most often following debridement of the diabetic foot. TNP was used less
frequently for treating arterial ulcers (after revascularisation), venous ulcers
and finally mixed arterial/venous ulcers. It was used only sometimes or never by
76% (arterial), 82% (venous) and 85% (mixed arterial/venous) of New Zealand
vascular surgeons.
The surgeons questioned found that they had the most success
when using TNP following debridement of the diabetic foot, with 62% of them
saying that they had good or greater success in this scenario. This is in
keeping with current literature that suggests that TNP may lead to more rapid
wound healing following surgery to the diabetic
foot.10
Vascular surgeons in New Zealand reported less success when
using TNP for arterial, venous and mixed ulcers. Less than 26% of surgeons had
anything better than good success when using TNP for treating ulcers of any
aetiology. TNP may accelerate healing in patients with chronic venous ulcers who
are also treated with bed rest and punch
grafts,2,16 however there is no evidence to
support its use in arterial ulcers.
Despite some evidence to suggest the benefits of TNP for
treating venous ulcers, this is not reflected in the experience and opinion of
New Zealand vascular surgeons - it is more frequently used in New Zealand to
treat arterial ulcers. TNP may not be the favoured method for treating venous
ulcers, given that more traditional compression therapy continues to prove
beneficial.
One report has been published of TNP successfully managing a
MRSA infected/dehisced femoro-popliteal bypass surgical wound in a diabetic
patient.20 A larger series reported 33 patients
with femoro-popliteal bypass graft post op groin infections and their subsequent
treatment with TNP.21 Although there was no
control group, the authors reported significant adverse effects of TNP in this
population - including serious TNP associated bleeding and late false aneurysm
formation.21 TNP treated graft infections were
associated with a high risk of developing infection-related
complications.21 Non-healing surgical site
infections were associated with amputation and death.
21
No RCTs have reviewed the use of TNP for treating lower limb
surgical wound infections/dehiscences. Despite this, this was the second
commonest situation that TNP was used for by New Zealand surgeons. 45% of
surgeons used TNP often for treating lower limb surgical wound
infections/dehiscences, with 50% perceiving success as above average. More RCTs
are needed, evaluating the use and safety of TNP for treating these wounds,
before its routine use can be justified.
No papers have been published specifically evaluating the
effectiveness of TNP for its use in lymphocoeles, seromas or lymph fistulas. The
results of this audit suggest that it is rarely used in New Zealand for
this—62% questioned had never used TNP in this clinical situation, the
most frequent of all responses.
Despite this one surgeon rated that TNP was very good for
treating lymphocoeles, seromas or lymph fistulas that were difficult to control
with conservative measures and 21% of surgeons rated that they had good success.
Its use in this scenario seems to be based entirely on anecdotal favourable
clinical experience.
It would seem that use of TNP derives mostly from personal
experience. The results of this audit suggest that 50% of surgeons in New
Zealand using TNP admit to not being currently up to date with published
research. The criticism of the published literature apparent in recent
systematic reviews might caste some clinical doubt on the role of TNP. There is
however a gradually expanding evidence base allowing clinician’s to make
informed choices for optimal use of TNP.4
Individual trials suggest that TNP may be beneficial in
treating diabetic foot ulcers, venous ulcers and arterial ulcers (post
revascularisation). Systematic reviews challenge the validity of these results,
given the poor methodological quality of many of these
RCTs.6,7 As a consequence, definitive
conclusions and clinical guidelines for the use of TNP are difficult to
formulate and remain controversial. There still remains a large gap between
evidence based data and routine clinical
experience.5 Although TNP appears effective, it
still remains unclear as to whether or not it is more effective than other wound
closure techniques.22
The technology of TNP is continuously advancing, with
impregnated foams and gauze containing growth factors or other agents (e.g.
silver for altering wound environment) being introduced to the
market.4 This will add to the difficultly of
drawing conclusions through systematic reviews and meta-analyses, because to
date none of the RCTs have used this technology.
Currently in New Zealand TNP is most commonly used for
diabetic foot wounds post debridement, lower limb surgical wounds and arterial
followed by venous ulcers, with perceived success correlating with this order of
popularity. There is a need for surgeons in New Zealand to understand the
controversies regarding TNP.
Note: Results of the audit were
recently presented at the Vascular Society of New Zealand annual conference in
Tauranga, February 2009.
Competing interests: None known.
Author information: Jacqui L Laney, Senior
House Officer, Emergency Department, Justin Roake, Vascular and Transplant
Surgeon, Department of Vascular, Endovascular and Transplant Surgery,
Christchurch Public Hospital, Christchurch; David R Lewis, Vascular Surgeon
& Senior Lecturer, Department of Vascular, Endovascular and Transplant
Surgery, Christchurch Public Hospital & Christchurch School of Medicine,
University of Otago, Christchurch
Correspondence: Dr Jacqui Laney, Emergency
Department, Christchurch Public Hospital, Private Bag 4710, Riccarton,
Christchurch, New Zealand. Email: Jacqui.Laney@cdhb.govt.nz
References:
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