Clinical question
Should negative pressure wound therapy (NPWT) versus standard wound therapy be used to promote healing in individuals with pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Conflicts on Interest:
Individuals with a pressure injury
Negative pressure wound therapy
Standard wound therapy
Any clinical setting
Hierarchy of outcome measures:
Outcome 1: Time to healing
Outcome 2: Complete healing (total/percent healed)
Outcome 3: Change in wound size (% change)
Outcome 4: Pain
Outcome 5: If infected at baseline, changes in signs and symptoms of infection
None
Evidence to Decision Framework
(Click on the individual judgements for more information)
Summary of Judgements
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Yes
Moderate
Trivial
Very low
No important uncertainty or variability
Probably favors the intervention
Varies
Low
No included studies
Varies
Probably yes
Probably yes
1. Problem:
Is the problem (pressure injuries) a priority?
JUDGEMENT
No
Probably No
Probably Yes
Yes
Varies
Don’t Know
RESEARCH EVIDENCE
The problem of treating pressure injuries is a significant priority to healthcare. Treating pressure injuries to achieve healing is a priority to most individuals who experience a PI. In 2021, the Guideline Governance Group undertook a stakeholder survey on priority issues to address in the guideline. Receiving clinical guidance on biophysical agents as a category (e.g., electrical stimulation, laser treatment, ultrasound, negative pressure wound therapy, etc.) for treating pressure injuries (PIs) was rated as a high priority by clinicians (median ranking 5/5), people with or at risk of PIs and their informal carers (median ranking 4/5) and by industry representatives (median ranking 4/5). In an earlier survey conducted by the previous Guideline Governance Group in 2018,(Haesler, Pittman et al. 2022) 87.86% (297/338) of individuals with or at risk of PIs and 88.01% (602/684) of informal carers rated receiving information on how to help pressure injuries heal as important or very important.
2. Desirable Effects:
How substantial are the desirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
| Outcome | NPWT | no NPWT | Difference | Relative effect |
|---|---|---|---|---|
| Time to healing | -- | -- | WMD −16.47 days 95% CI −22.36 to −10.59 days |
-- |
| Complete healing | 7/28 (25%) | 1/22 (4.5%) | 134 more healed PIs per 1,000 (from 12 fewer to 918 more) |
RR 3.95 (0.74 to 21.20) |
| Change in PI surface area (cm2) | -- | --/td> | -- | -- |
| Change in pain score | -- | -- | WMD −2.39 95% CI −3.47 to −1.30 |
-- |
Outcome 1: Time to complete PI healing
A meta-analysis (Song, Wang et al. 2021) of ten randomised controlled trials (RCTs)(Li, Xie et al. 2009, Zhang, Chen et al. 2010, Liu and Ge 2012, Su and Tang 2012, Wang and Wu 2012, Guo, Yang et al. 2013, Zhou 2014, Shen, Shen et al. 2015, Hong 2016, Liu, Geng et al. 2016) explored the impact of NPWT in reducing the time taken for Category/Stage 3 and 4 PIs to completely heal compared with standard wound treatment (debridement plus a standard wound dressing). There was a statistically significantly reduced time to complete PI healing and the reduction in time to heal was reported to be of a moderate effect size (Song, Wang et al. 2021); however, the evidence was very uncertain. The certainty of evidence was downgraded due to risk of bias, and the wide confidence interval (CI) that crossed the value between recommending and not recommending using NPWT.
Outcome 2: Complete PI healing
We updated a Cochrane meta-analysis (Shi, Gao et al. 2023). The new meta-analysis included two RCTs (Ashby, Dumville et al. 2012, Ahmad, Khanna et al. 2022) exploring the effectiveness of NPWT compared with standard wound treatment for Category/Stage 3-4 PIs. In one of the studies,(Ahmad, Khanna et al. 2022) application of povidone iodine cream was part of the standard wound treatment. In the meta-analysis, more PIs reached complete healing, but the difference was not statistically significant (25% versus 4.5%, relative risk [RR] 3.95, 95% confidence interval [CI] 0.74 to 21.20, p=0.11). This was a large effect size. This translated to 134 per 1,000 more PIs healing (from 12 fewer to 918 more). There is very low certainty in this result; the certainty of evidence was downgraded due to risk of bias, and imprecision.
Outcome 3: Change in PI surface area (cm2)
A Cochrane review (Shi, Gao et al. 2023) included two RCTs (Dwivedi, Srivastava et al. 2016, Dwivedi, Bhagat et al. 2017) that reported the impact of NPWT on change in PI size. The review reported that reduction in PI length, width and depth were significantly (p<0.01) greater compared to PIs treated with standard treatment. However, specific values were not available and change in surface area could not be calculated. There was very low certainty of evidence with downgrading for risk of bias, indirectness of outcome measure and imprecision (Shi, Gao et al. 2023).
Outcome 4: Reduction in pain score
A meta-analysis (Song, Wang et al. 2021) of three RCTs(Su and Tang 2012, Zhou 2014, Shen, Shen et al. 2015) reported evaluation of participants’ pain. The meta-analysis showed a statistically and clinically significant reduction in pain score associated with NPWT (weighted mean difference −2.39, 95% CI −3.47 to −1.30, p<0.0001). There was very low certainty of evidence, with downgrading due to risk of bias and imprecision.
** Devices and regimens are described in the data extraction tables. Product names may have changed.
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
A Cochrane review (Shi, Gao et al. 2023) reported evidence from 1 RCT (Ashby, Dumville et al. 2012) (n=12 participants). There was no significant difference in adverse events between the NPWT group and the standard treatment group (83% versus 67%, RR 1.25, 95% CI 0.64 to 2.44, p>0.05), which was a small effect. The evidence was of very low certainty due to the high risk of bias and imprecision (Shi, Gao et al. 2023).
4. Overall certainty of evidence: What is the overall certainty of the evidence of effects?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
| Outcome | Relative Importance | Certainty of Evidence |
|---|---|---|
| Time to complete healing/td> | CRITICAL | LOW |
| Complete healing | CRITICAL | LOW |
| Change in PI surface area (cm2) | CRITICAL | LOW |
| Pain | CRITICAL | LOW |
There is no core outcome set specific to pressure injury healing. To determine the relative importance of outcome measures, the GGG reviewed literature (Gottrup, Apelqvist et al. 2010, Augustin, Schmitt et al. 2014, Driver, Gould et al. 2017, Driver, Gould et al. 2019, Miranda, Deonizio et al. 2021, Raepsaet, Alves et al. 2023, Gupta, Goldstone et al. 2024, Zhang, Zhang et al. 2024) on PI and wound healing outcome measures and, in 2021, undertook a survey of stakeholders regarding their perspective on the importance of commonly reported wound healing outcomes. Based on the review and survey, the GGG prioritized consideration of the following five outcome measures of interest when evaluating evidence for interventions to support PI healing (see below). These clinical outcomes were supported by all surveyed stakeholder groups as critically important to making decisions about the evidence, and are wound agnostic(Gupta, Goldstone et al. 2024), frequently reported in PI research (Miranda, Deonizio et al. 2021), and relevant to both clinical practice and quality of life for individuals with a PI (Driver, Gould et al. 2017, Driver, Gould et al. 2019). The hierarchy of selected outcome measures was:
Outcome 1: Time to healing
Outcome 2: Complete healing (total/percent healed)
Outcome 3: Change in wound size (% change)
Outcome 4: Pain
Outcome 5: If infected at baseline, changes in signs and symptoms of infection
Certainty of evidence for outcomes measures
Certainty of evidence for time to complete PI healing was very low. The certainty was downgraded twice due to both studies having high risk of bias in two or more domains. The evidence was also downgraded once for inconsistency due to significant heterogeneity.
Certainty of evidence for percent of PIs reaching complete healing was very low. The certainty was downgraded twice because both studies had high risk of bias for two or more domains and was downgraded twice for imprecision due to small sample size and wide confidence interval crossing the value between recommending and not recommending the treatment.
Certainty of evidence for change in PI surface area was very low. The certainty was downgraded once due to risk of bias, once for indirectness and once for imprecision. The data indicated a non-specific size decrease (width, length and depth) but the information was inadequate to calculate mean change in surface area, hence the downgrade for indirectness (Shi, Gao et al. 2023).
Certainty of evidence for change in pain score was very low. The certainty was downgraded twice due to all studies have high risk of bias in two or more domains and once for imprecision due to significant heterogeneity.
5. Values:
Is there important uncertainty about or variability in how much people value the main outcomes?
JUDGEMENT
Important uncertainty or variability
Possibly important uncertainty or variability
Probably no important uncertainty or variability
No important uncertainty or variability
RESEARCH EVIDENCE
In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical important (score of 7-9) by all types of stakeholders (health professionals, people with or at risk of a PI and their informal carers, industry representatives and researchers). Greater than 90% of the 158 participants rated this outcome measure as critically important (Lechner, Coleman et al. 2022).
6. Balance of Effects:
Does the balance between desirable and undesirable effects favour the intervention or the comparison?
JUDGEMENT
Favors the comparison
Probably favors the comparison
Does not favor either the intervention or the comparison
Probably favors the intervention
Favors the intervention
Varies
Don’t know
RESEARCH EVIDENCE
The desirable effects were moderate and reported undesirable effects were trivial.
7. Resources Required:
How large are resource requirements (costs) of the intervention?
JUDGEMENT
Large costs
Moderate costs
Negligible costs and savings
Moderate savings
Large savings
Varies
Don’t know
RESEARCH EVIDENCE
Studies report that NPWT reduces nursing and physician time in terms of wound dressing changes (Dwivedi, Bhagat et al. 2020, Ahmad, Khanna et al. 2022). A controlled trial reported that the total cost of a 9-week treatment of one pressure injury using with NPWT was approximately 46% less than the costs of conventionally treated comparable ulcer. The analysis included the costs for wound dressings, cleansing solutions and nursing costs (Srivastava, Dwivedi et al. 2014). However, the certainty that this costing considered all the required resources is low. An RCT (Walker, Aitken et al. 2015, Dwivedi, Srivastava et al. 2016, Dwivedi, Bhagat et al. 2017) reported NPWT treatment costs were $105 compared with $200 for treatment with standard wound dressings (USD in 2016). A Cochrane analysis (Shi, Gao et al. 2023) noted that this was very low certainty of evidence and that full cost data was lacking. All the studies above used low resource versions of NPWT that may not reflect costs in high resource settings.
8. Certainty of evidence of required resources:
What is the certainty of evidence of resource requirements (costs) of the intervention?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
A Cochrane analysis (Shi, Gao et al. 2023) noted that the evidence on cost was very low certainty of evidence and that full cost data was lacking. All the studies reported in the evidence summary used low resource versions of NPWT that may not reflect costs in high resource settings. The GGG voted that the certainty of evidence for resources was low.
9. Cost Effectiveness: Does the cost-effectiveness of the intervention favour the intervention or the comparison?
JUDGEMENT
Favors the comparison
Probably favors the comparison
Does not favor either the intervention or the comparison
Probably favors the intervention
Varies
No included studies
RESEARCH EVIDENCE
There is no available evidence.
10. Inequity:
What would be the impact of recommending the intervention on health inequity?
JUDGEMENT
Reduced
Probably reduced
Probably no impact
Probably increased
Increased
Varies
Don’t know
RESEARCH EVIDENCE
The NPWT devices varied across the studies and included both NPWT constructed from traditional components and contemporary sophisticated commercial products. The studies were conducted in a range of geographic settings, including low resource settings, and positive outcomes are reported with use of low-cost NPWT options (Srivastava, Dwivedi et al. 2014, Dwivedi, Srivastava et al. 2016, Dwivedi, Bhagat et al. 2017, Dwivedi, Bhagat et al. 2020).
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
A qualitative systematic review that included five studies reported that NPWT had an impact on the quality of life of individuals and recommended that the use of NPWT be explained to individuals in a way that would promote their sense of self-control. In this review, the major themes found that NPWT increased perception of wound odor, was perceived as increasing the individuals dependency on health professional, was a threat to the individual’s perception of normality and increased feelings of personal discomfort, shyness and embarrassment (Janssen, Wegdam et al. 2020). One study with 24 individuals receiving NPWT to treat a PI reported that the participant adherence to the NPWT protocol was good to excellent, suggesting the participants found the treatment acceptable (Srivastava, Dwivedi et al. 2014).
12. Feasibility:
Is the intervention feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
Studies report that NPWT can be effectively used in outpatient settings (Srivastava, Dwivedi et al. 2014, Papp 2019), and has the advantage of requiring less frequent wound care than standard wound care options (e.g., weekly wound dressing attendance in outpatient settings versus in-patient care and/or daily dressing changes) (Srivastava, Dwivedi et al. 2014, Dwivedi, Bhagat et al. 2020). Studies have also reported that individuals and their carers can be successfully taught how to manage NPWT in the home setting (Dwivedi, Bhagat et al. 2020). One study reported that NPWT was not feasible in sacral PIs close to the natal cleft due to difficulty achieving appropriate adhesion not attain an airtight seal (Srivastava, Dwivedi et al. 2014).
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