A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay

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A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay

The essay analyzes the work done by Bolas and Holloway, organizing the analysis into a critique of the justification of their study, literature review, design of the study, data collection, data analysis, and the summary.
Negative pressure wound therapy is a form of treatment whereby a physician exerts pressure on uniformly on a wound in order to cause the wound to heal (Stansby et al. 2010). This form of treatment is modern and a lot more non-intrusive as compared to other pre-existing methods of healing wounds. A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay. Even so, like any other treatment plan, NPWT leaves a mark on the lives of those who take it up as a preferred method of treatment. Several researchers have attempted to study the effect of NPWT on the lives of the patients. Is the treatment more desirable than other forms of treatment that have been there before? Does it leave a lasting positive impact or is it in the end scaring to its recipients?
Bolas and Holloway’s in their report, Negative pressure wound therapy: a study on patient perspective’ set out to establish the impact of NPWT on the overall lives of patients that receive this form of treatment. Research and Evidence Based Practice The study conducted on NPWT is important in nursing because of its nature as a modern form of treatment. …
The definition given in the essay makes the concept of NPWT clear to readers. Precision and clarity of this nature can be found throughout report. This is perhaps a product of the fact that both authors are prominent professionals in the field of nursing, with Bolas being a clinical nurse specializing in tissue viability, and Holloway a senior lecturer on wound healing at the school of healing. One can, therefore, trust in the credibility of the information provided in the report. The abstract of the report clearly outlines the organization of the study as statement of the problem, the research process, and the overall findings warranting a similar structure in the analysis. Importance of the study More patients are opting for NPWT than before. Some of the benefits that this form of treatment presents to patients include fewer dressing charges, the enhanced hygiene standards and ultimately, the faster healing of wounds (Moffatt et al. 2011).A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay. NWPT presents patients and nurses with convenient options that were previously not available. Even so, as Bolas and Holloway clearly state, there are not sufficient studies conducted on the impact of NWPT on human lives. The problem stated at the beginning of the essay clarifies what the study is about to the reader and bears connection to the research topic. This is one of the qualities of a good problem statement as Ryan, Coughlan and Cronin (2007) point out. In a bid to gain insight into the effect that NWPT has on the lives of patients, the study sought to find out what hinders the patients’ use of the therapy. In addition, they wanted to determine the best way to enable the patients to overcome the challenges they contend with due to the treatment regime.

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In armed conflict, injuries among civilians are usually complex and commonly affect the extremities. Negative pressure wound therapy (NPWT) is an alternative to standard treatment of acute conflict-related extremity wounds. We aimed to compare the safety and effectiveness of NPWT with that of standard treatment. A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay.

Methods

In this pragmatic, randomised, controlled superiority trial done at two civilian hospitals in Jordan and Iraq, we recruited patients aged 18 years or older, presenting with a conflict-related extremity wound within 72 h after injury. Participants were assigned (1:1) to receive either NPWT or standard treatment. We used a predefined, computer-generated randomisation list with three block sizes. Participants and their treating physicians were not masked to treatment allocation. The primary endpoint was wound closure by day 5. The coprimary endpoint was net clinical benefit, defined as a composite of wound closure by day 5 and freedom from any bleeding, wound infection, sepsis, or amputation of the index limb. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02444598, and is closed to accrual.

Findings

Between June 9, 2015, and Oct 24, 2018, 174 patients were randomly assigned to either the NPWT group (n=88) or the standard treatment group (n=86). Five patients in the NPWT group and four in the standard treatment group were excluded from the intention-to-treat analysis. By day 5, 41 (49%) of 83 participants in the NPWT group and 49 (60%) of 82 participants in the standard treatment group had closed wounds, with an absolute difference of 10 percentage points (95% CI −5 to 25, p=0·212; risk ratio [RR] 0·83, 95% CI 0·62 to 1·09). Net clinical benefit was seen in 33 (41%) of 81 participants in the NPWT group and 34 (44%) of 78 participants in the standard treatment group, with an absolute difference of 3 percentage points (95% CI −12 to 18, p=0·750; RR 0·93, 95% CI 0·65 to 1·35). There was one in-hospital death in the standard treatment group and none in the NPWT group. The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups.

Interpretation

NPWT did not yield superior clinical outcomes compared with standard treatment for acute conflict-related extremity wounds. The results of this study not only question the use of NPWT, but also question the tendency for new and costly treatments to be introduced into resource-limited conflict settings without supporting evidence for their effectiveness. This study shows that high-quality, randomised trials in challenging settings are possible, and our findings support the call for further research that will generate context-specific evidence. A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay.

Funding

The Stockholm County Council, the Swedish National Board of Health and Welfare, and Médecins Sans Frontières.

Introduction

In 2017, armed conflict killed about 95 000 people worldwide, nearly half of them in Iraq and Syria.

In these countries, conflict-related injuries are the leading cause of loss of disability-adjusted life-years.

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from the Syrian armed conflict found that 70% of direct deaths were civilians. Conflict-related injuries in civilians predominantly affect the extremities, and comprise wounds with or without fractures.

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Clinical management of conflict-related extremity wounds is challenging, requiring substantial resources, and it is often complicated by infection.

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Wound complications can result in prolonged treatment times and increased risk of morbidity and mortality.

The current gold standard in treatment of conflict-related wounds relies on experiences gained from armed conflict zones of the past century. A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay. Treatment includes initial wound debridement, followed by the application of a dressing to absorb excess fluid and protect the open wound from further contamination, until reassessment and, if possible, delayed wound closure in the operating theatre 3–5 days later.

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In negative pressure wound therapy (NPWT), the wound is covered, and negative pressure is applied. Expert consensus has suggested NPWT as an alternative to the gold standard treatment of traumatic wounds.

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Although NPWT has been used since the 1990s for chronic or complicated wounds,

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little evidence suggests that it promotes wound healing. Two systematic reviews

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concluded that the credibility of previous studies is substantially reduced because of poor study quality, low statistical power, or a high risk of bias with respect to random sequence generation, and use of inappropriate endpoints.

In the case of traumatic wounds, few randomised trials have been done, and all from non-conflict settings. Investigating differences in time to closure, risk of wound infection, and adverse events between NPWT and standard care, these studies have yielded mixed and conflicting evidence.

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Despite this finding, NPWT has been introduced as a treatment option for patients with conflict-related injuries, even in resource-limited settings, regardless of its additional costs. Therefore, we did a randomised controlled trial to compare the safety and effectiveness of NPWT against that of standard wound treatment, specifically in patients with acute conflict-related extremity wounds.

Methods

Study design

This is a pragmatic, randomised, controlled superiority trial, done at two civilian trauma hospitals in Jordan and Iraq. The study started at a hospital in Ar Ramtha, Jordan. The hospital is located close to the Syrian border and is supported by the international non-governmental organisation, Médecins Sans Frontières. At this hospital, patients receive treatment for conflict-related injuries sustained in Syria. Temporary closure of the Syrian border in June 2016 led to enrolment difficulties and, consequently, the trial was expanded to include a hospital in Erbil, Iraq. This hospital is run by the local non-governmental organisation, Emergency Management Center, and received patients from Mosul during the armed conflict in 2016–17. A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay.

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When the Syrian border was reopened in November 2016, patient enrolment in Jordan was resumed but was suspended again in February 2017.

Ethics approval for the study was obtained from the Ethics Review Committee of the Jordan Ministry of Health (MOH REC 150037), the Ethics Review Board of Médecins Sans Frontières (ID 1520), the Research Ethics Committee of Kurdistan Regional Government in Iraq (2:10 6/3/2017), and the Swedish Ethical Review Authority (2019–01975). All trial procedures adhered to the Declaration of Helsinki and guidelines for Good Clinical Practice. Additionally, an external monitor regularly reviewed unmasked data in confidence. The study design and methods have been described elsewhere.

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The trial protocol is available online. The trial is registered with ClinicalTrials.gov, NCT02444598.

Participants

Patients eligible for study participation had to be aged 18 years or older, and they had to present at the emergency department within 72 h of sustaining a conflict-related extremity wound. Patients with a wound deemed suitable for primary closure (eg, small or superficial) were not included. All participants gave written informed consent. Because acutely injured patients are often not fully conscious when being transported from the emergency department to the operating theatre, the principle of delayed consent was used. Thus, those patients entered the study under presumed consent. Informed consent for their continuation as participants in the trial was then collected at the first appropriate opportunity, within 5 days of their random allocation. Patients not able to give consent by day 5 were excluded from the study.

Randomisation and masking

Participants were randomly assigned (1:1), via a computer-generated randomisation code with random variation of three fixed block sizes (4, 6, 8) to receive either NPWT or standard treatment. An investigator with no clinical involvement in the trial prepared the allocation sequence. The sequence was concealed from researchers responsible for enrolling and assessing participants. The attending surgeon determined eligibility and enrolled the participants. A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay. The sequentially numbered, opaque, sealed randomisation envelopes were kept in an agreed location in each operating theatre. To enter a patient into the study, the operating theatre nurse opened the next consecutively numbered envelope at the end of the primary surgery, but before the wound dressing was applied. Participating staff, patients, and researchers were not masked to treatment allocation. Wounds were photo-documented, and photographs were assessed by two independent clinicians who were masked to treatment allocation.

Procedures

NPWT dressings involved the application of sterile, open-cell, solid foam covered by a plastic film, through which a negative pressure was applied. This technique enables blood and fluid to be drained from the area, while keeping the wound moist. A professional NPWT device (Conformité Européenne) was used, with a continuous negative pressure of 125 mm Hg (in Jordan, we used Vacuum Assisted Closure by KCI, San Antonio, TX, USA; in Iraq, we used Fava by EZM, Ankara, Turkey).

Standard wound dressings were applied in accordance with the International Committee of the Red Cross war surgery protocols.

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These dressings were non-adhesive sterile gauze covered with a bandage, applied at the discretion of the treating surgeon.

All participants received prophylactic treatment with cefazolin or amoxicillin plus clavulanic acid. Metronidazole or gentamicin was added for patients with open fractures. Fractures were immobilised by external fixation. The treating surgeon changed the dressings in the operating theatre every 3–5 days and did further wound debridement if needed. Participant follow-up occurred at each dressing change, at hospital discharge, at days 14 and 30, and at 3 months following day of randomisation.

Outcomes

The prespecified primary endpoint (effectiveness) was wound closure by suture, flap, or split-thickness skin graft, within 5 days from initial debridement surgery. The prespecified coprimary endpoint (safety) was net clinical benefit, defined as a composite of wound closure by day 5 and freedom from any bleeding, wound infection, sepsis, or amputation of the index limb. In this paper, we report the prespecified secondary endpoint of time to wound closure. In case of closure failure, time to final closure was recorded. We also report the prespecified safety endpoints of wound infection (defined as purulent discharge), sepsis, bleeding leading to blood transfusion, amputation of the index limb, and death. The incidence, nature, and severity of adverse events were assessed in all participants by the research team.A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay.

The other secondary endpoints, which will be reported elsewhere, were: wound size ratio at day 14; time until wound is deemed no longer requiring professional care; number of surgeries; time to hospital discharge; quality-of-life aspects; wound healing at follow-up days 14 and 30, and at 3 months; direct health-care costs (substudy); and cost-effectiveness (substudy). We used patient-centred endpoints and follow-up periods as suggested by the US Food and Drug Administration.

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Definitions have been reported elsewhere.

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Statistical analysis

We based the target sample size on the assumption that 75% of participants in the NPWT group would reach the primary endpoint by day 5, compared with 50% of participants in the control group (these calculations were based on a review of the literature and discussions with medical doctors with experience from conflict-related trauma care). We calculated that 58 participants per treatment group, at a significance level of 5%, would give the study 80% power. Considering the nature of the study setting, we anticipated higher dropout levels than might be expected in other trials. To adjust for dropouts, we therefore aimed to recruit 200 participants (100 per group).

Analysis was done on the intention-to-treat population. No interim analyses were done. Continuous variables are reported as median (IQR), whereas categorical variables are reported as numbers and proportions. Between-group differences in categorical variables were compared with Fisher’s exact test. We calculated two-sided 95% CIs for absolute differences in the proportions of outcomes, according to the method of Jeffreys. A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay.

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We estimated time to closure with the Kaplan-Meier method, and used the Mantel-Haenszel log-rank test to compare Kaplan-Meier cumulative incidence curves. A standard Cox proportional hazards model was used for estimating the relative chance of closure (hazard ratios [HRs] and 95% CIs), with the standard dressing group used as the reference. Furthermore, inspection of log–log plots and a global test based on Schoenfeld residuals indicated that the proportional hazards assumption was not violated. A two-sided p value of less than 0·05 was considered to indicate statistical significance. We did statistical analyses with R version 3.5.0 software.

Role of the funding source

The funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Results

Between June 9, 2015, and Oct 24, 2018, 174 participants were enrolled, of whom 88 were randomly assigned to receive NPWT and 86 to receive standard treatment (figure 1). Two participants, one from each treatment group, were excluded after randomisation because they were found to be ineligible. Due to cognitive impairment, two participants from the NPWT group and one from the standard treatment group were unable to provide delayed consent after randomisation. Two participants, one from each group, died within 5 days; one from the standard treatment group left against medical advice, and one participant in the NPWT group was arrested by the police, both within 5 days. Consequently, 165 participants with data on primary outcome (83 in the NPWT group, 82 in the standard treatment group) were included in the intention-to-treat analysis. A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay. Table 1 summarises the study population characteristics at baseline. The groups were well balanced in baseline characteristics, except for wound area and proportion of participants with exposed bone and vital structures.

A Critique on Negative Pressure Wound Therapy: Patient Perspectives Essay