Negative Pressure Wound Therapy - Why all that Glitters is not Gold
Negative Pressure Wound Therapy - Why all that Glitters is not Gold
At the end of 2014, the Médecins Sans Frontières (MSF) Sweden Innovation Unit (SIU) was approached by our colleagues in Amsterdam to assess the potential for improved patient outcomes with Negative Pressure Wound Therapy (NPWT) – a therapeutic technique that uses a suction pump with tubes and a sealed dressing to create negative pressure and thereby remove excess exudate and reduce wound size. The war in Syria has, since 2011, throwing the country into chaos, at that time peaking in terms of conflict-related deaths and injuries – amongst armed groups as well as civilians. In 2014, MSF had already many projects in neighboring countries aiming to provide support to those fleeing the bloody conflict. One of those projects was in Ar Ramtha, a Jordanian town so close to the southern Syrian border that its citizens could clearly hear the bombs falling just a couple of kilometers away, where MSF Operational Centre Amsterdam (OCA) ran surgical activities since 2013 for Syrian war victims, those that were able to cross the border.
It has been five years since the initial launch of the NPWT Case was launched. Thanks to the unwavering dedication of staff on the ground, a determined research team, and a resilient partnership structure that endured the unexpected difficulties of field realities this project has achieved its initial objective and provided some insightful learnings along the way. The knowledge generated by this research can hopefully serve current and future surgical interventions for patients with conflict-related trauma wounds, whether within MSF, the wider humanitarian sector, or beyond.
Initial insights from this investigation were recently PUBLISHED in The Lancet, Global Health as a collaborative effort between MSF, Karolinska Institutet, the Jordan University och Science and Technology, and Hawler Medical University. The study enrolled 174 adult patients with acute conflict-related extremity wounds. The patients were randomized to either standard wound care or NPWT. NPWT did not result in clinically superior outcomes compared to standard treatment. In addition, the study highlights that high-quality, randomized trials in challenging settings are possible and emphasizes the need for a scale-up of more context-specific research.
How the investigation started
Our colleagues in MSF had received continuous reports that the patients from the Syrian war, often with severe wounds rendered from gunshots or barrel bombs, had concerningly high rates of postoperative complications, often due to wound infection. The high complication rates were not entirely unexpected as patients often had to take long routes to pass the border and finally reach the Ar Ramtha hospital. This route inevitably led to prolonged time, often several days, from injury to patients finally receiving surgical care. In addition, patients' wounds were often grossly contaminated due to the injury mechanism and their challenging journeys. Complication numbers were so alarming that the surgeons at the hospital were strongly motivated to explore alternative wound treatment options to the standard, well established dressing-based approach (using non-adhesive sterile gauze covered with a bandage), described in the ICRCS WAR SURGERY PROTOCOLS. These surgeons were a part of an international pool and frequently rotated globally and highly accustomed to NPWT, bringing them to wonder whether this technique could also be used in Syrian patients.
It was with this question, and intent, that our colleagues in Amsterdam approached us. Could the SIU support MSF in testing NPWT in the Ar Ramtha project? NPWT is by no means new or an innovative approach in itself – this treatment has been around since the 90s. But what was new, or largely unknown was the indication and context: war wounds in a humanitarian setting.
The SIU soon realized that we had to reach out to our network in order to get advice and potentially the right expertise on board. Luckily, a wide range of people have gone to the field through the MSF Sweden office, so we didn’t have to look that far to find the expertise and insight we needed. We discussed the matter with one such expert, Dr Andreas Älgå, a surgeon with MSF field experience linked to the Centre for Research on Health Care in Disasters at Karolinska Institutet. It became clear that no comparative studies had been performed to assess whether NPWT is a superior treatment compared to standard wound treatment for war wounds. There was simply not sufficient scientific evidence available to guide an informed decision. This essentially left us with three choices;
Start implementing NPWT and collect observational outcome data and qualitative feedback from health staff and patients in Ar Ramtha
Conduct a prospective operational research study to assess the value of a potential scale-up of NPWT
Disregard NPWT as a treatment option
Needless to say, we selected alternative 2, however, if we had known in advance how long this would take combined with the uncertainties and challenges that came along with this study, the decision may not have been as easy to make.
Still, there were many valid reasons why we wanted to start this operational research study – and we were well aware of the challenges that come with it. Beyond the lack of evidence on the topic, the fact that in Jordan, patients with acute war wounds were treated in a middle-income and relatively stable context. This provided a unique opportunity to conduct this study. There was a wide split between surgeons, surgical referents and experts within the movement. While some of the field surgeons wanted to implement NPWT without hesitation there were others that were fiercely in opposition of the technique altogether. Others simply didn’t know where to stand due to the paucity of evidence. In addition, based on the number of patients arriving at Ar Ramtha hospital in the study lead-up we estimated that the necessary sample size could be achieved in less than 6 months, reinforcing the feasibility of the study.
After the decision was taken by all stakeholders, roll-out moved fast, in-particular considering that we set out to do a research study with patients in extremely vulnerable situations meaning everything had to be conducted in a highly ethical manner and carefully planned. Besides getting the green light from MSFs internal Ethical Review Committee we also had to attain approval from the Jordan Ministry of Health (MoH). The SIU Innovation Lead, Marpe Tanaka, and Andreas Älgå traveled to Jordan to prepare the study by meeting the Jordanian coordination team in Amman, the clinical team in Ar Ramtha, as well as collaborators at the Jordan University och Science and Technology, and Jordan MoH representatives within two visits, leading to the study being officially started in June 2015.
Part 1. Ar Ramtha, Jordan
Although patient numbers were lower than the initial estimations, an overall positive challenge for the team to face, the study started on a strong footing despite the added complexity of this type of investigation wherein allowing for minimal disruption of existing clinical activity was paramount. RESEARCH PROTOCOLS were transformed into practical routines where patients after the surgeon assessed their eligibility according to inclusion criteria (extremity wounds, >18 years, etc.), were randomly assigned either NPWT or standard treatment. The research assistant would then assure that the patients provided written consent before including them in the study and then follow the patients to monitor primary endpoints (wound closure within 5 days), co-primary, and secondary endpoints (net clinical benefits, wound infection, etc.) as well as photo documentation. What was a new practice within the surgical and post-surgical ward in Ar Ramtha hospital soon became routine.
Around one year after the study was initiated, an event changed the course not only for the research study but for the Ar Ramtha project as a whole. Six Jordan border guards were killed in a suicide attack leading to sealed northern and eastern Jordanian borders. This had a devastating effect on those Syrian war victims that no longer could get surgical care in Ar Ramtha. Consequently, this also led to a rapid decrease of patient enrolment in the study. At this point, around 80 patients, or about half of the number of patients to reach the target number from the power calculation. During a considerable period, the study and the wider Ar Ramtha project were in limbo awaiting any change in the firm border restrictions from the Jordan authorities, hoping that patients could once again get access to medical care. A decision had to be taken and as there was no change in regard to the closed border. MSF/OCA activities shifted focus towards other healthcare support functions, and the research study did no longer have allocation or patients only halfway through.
Part 2. Erbil, Iraq
At this point, MSF, beyond having other concerns and priorities than a research study, had no possibility to house it. This could just as well have been the end, merely reaching an attempt to fill the gap within this area of research, but thanks to coincidence and the network of the research team a new potential location where the study could be continued were identified. Erbil in Iraq had a similar profile as Ar Ramtha, at least from the perspective of this study. There was a steady flow of patients from the armed conflict in Mosul with traumatic wounds similar to the ones from the Syrian conflict, and Erbil was, even though far from as stable as Jordan, at least relatively stable. After another round of ethical review board applications, negotiations, and practical agreements with the local MoH in Erbil, the study entered a second phase and had now become a multisite trial. Patients in Erbil were enrolled in the study during 2016-2017 assuring that a sufficient number of 174 patients in total were reached.
So, what can we learn?
NPWT did not improve the prevalence of wound closure by day 5. In addition, there was no difference in net clinical benefit or reduced levels of infection. In the end, the research team questions the introduction of NPWT for the treatment of war-related trauma wounds in humanitarian settings. Besides that it does not provide any significantly improved health-related outcomes, it is a more expensive treatment technique, and it requires more stable infrastructure, supply chain, maintenance, and support functions than standard wound treatment. We at the SIU also recognize and acknowledge that it is easy to get carried away with what is new and “untested”. Already long before we had the final outcomes of the study in our hands, we were discussing potential routes to develop low resource NPWT systems more adapted to our contexts. Insatiable curiosity and the passion to test what others have not are trademark qualities of innovators but sometimes we must take a step back, reassess and simply wait until we have the information we need, sometimes as long as for five years, as also stamina and endurance are key ingredients for successful innovation.
Three core learning emerged from this process and investigation that we hope can guide future efforts in similar contexts:
Not all that Glitters is Gold. More expensive and more sophisticated does not automatically mean that a solution or therapy is better than conventional “low tech” approaches. Especially within low resource, humanitarian contexts.
Place Evidence before Assumptions. Innovation and operational research have many intersections and overlaps and can complement each other in a very good way. Sometimes we need the more fast-tracked approach of innovation and design methodologies to get a good idea on how to solve a problem but if we need to provide evidence-based decisions within an unclear subject we have to rely on research methodologies to acquire the necessary information
Find the Strength of Partnerships. Collaboration does not only assure that we get the right competencies and resources on board to reach a common goal. It also makes the endeavor less vulnerable to unexpected events and challenges.
If you are interested in learning more about this investigation, connecting with the SIU about a potential humanitarian health innovation case, or have any other queries, please reach out on SIU@STOCKHOLM.MSF.ORG