Dr Matthew Bayfield, Medi-Solfen® researcher talks about the potential of this Medical Ethics product currently in development as a potential over-the-counter solution that could benefit a wide range of people; from parents to ambulance personnel and medics working in difficult locations such as battlefields.
Wounds result in a significant cost to the UK Healthcare system. It has recently been estimated the annual cost for treating wounds is £5 billion1 and this will rise significantly due to the increased proportion of elderly patients living longer. This figure represents 3% of the total healthcare spend. In terms of the community sector 60% of those wounds treated are chronic and the 3 major types seen are leg ulcers, diabetic foot ulcers and pressure ulcers. In the UK it is estimated that population prevalence rates generally fall in the range of 1.2–3.2 per 1,000 people.2 which means there are 70,000–190,000 individuals in the UK with a venous leg ulcer at any time. The cost to the NHS of treating patients with venous ulceration, mostly in primary care and through community nursing services, is at least £168–198m per year.3
The presence of dead or necrotic tissue (including slough) on the surface of any wound including venous leg ulcers will delay wound healing. Debridement which facilitates removal of such barriers to healing is an integral part of wound bed preparation and comprises the T (tissue removal) element in the TIME continuum to promote healing endorsed by most key opinion leaders and consensus groups4,5.
Patients with wounds often experience pain. However, there is evidence that this is often underestimated or mismanaged by health professionals6.
In addition, there are many psychological and emotional factors associated with living with a wound that can affect patients’ perception of pain, such as anxiety, stress fear and depression7.
Sharp debridement of non-viable tissue is a frequent treatment modality for leg ulcer patients. However, the procedure is not well tolerated and patients will often ask the clinicians to stop before the debridement is completed because of the pain.8,9,10
It is possible that patients will deny future consent for the sharp debridement if the first experience was painful. This also impacts on the confidence of trained physicians to achieve the depth of tissue removal necessary for optimising the process of wound bed preparation. This poses difficulties in providing optimal care and in achieving healing in a timely manner. Delayed healing eventually creates additional costs and deterioration in the patient’s quality of life. The UK NHS advocates a patient-centred approach, an approach that promotes physical comfort, including pain management11.
Current therapeutic options for wound pain relief during debridement include drug-based creams (EMLA cream) which take up to 1 hour to take effect prior to use of the scalpel8,10 and creates practical challenges in retention and possible re-application and hydrogels that may have to applied very frequently over weeks to achieve a clean wound bed12.
There is a clear need for an easy to apply product that will provide almost instantaneous and continuous pain relief prior to and after the debridement procedure. This will ensure increased confidence in achieving the wound bed preparation goals. From a patient perspective, whether it is their first time or an additional procedure, such benefits will remove any anxiety, fear or compliance with their treatment strategy. There is a clear fit with the NHS goals of achieving a patient-centred approach that promotes physical comfort, including pain management.13
From an economic perspective use of Medi-Solfen® has the potential to allow multiple debridement procedures to be routinely achieved at the start of any consultation which has the potential to result in faster healing14,15. Savings will be realised in terms of fewer nurse practitioner visits, dressing and retention bandages and in patient stays.
Surgical debridement uses sharp instruments (such as a scalpel, scissors and other sharp instruments) to remove necrotic tissue from the wound bed, either at the patient’s bedside or in specialised clinics. The advantages of such approaches include excellent control over the selection of tissue type to be removed and how much tissue to remove. It is the fastest way to achieve a clean wound bed and an increased frequency of debridement of this kind has the potential to speed up the healing process1,2 which presents clinical, patient and economic advantages. A major disadvantage is that the use of sharp instruments may be painful for the patient. The pain type is described as procedural/operative pain which by definition causes pain that results from routine procedures such as dressing changes or wound cleansing, or is associated with significant wound interventions, such as biopsies or debridement3. Rapid control of such pain will impact on the patient’s overall experience of the procedure and also improve subsequent compliance to attend future events of this nature and adhere to dressing changes. It is possible that patients will deny future consent for the sharp debridement if the first experience was painful. This poses difficulties in providing optimal care and in achieving healing in a timely manner. Delayed healing eventually creates additional costs and deterioration in the patient’s quality of life. Some anaesthetic containing creams such as EMLA can take up to 1 hour post application to attain sufficient levels of anaesthesia to allow the debridement process to commence. This extends considerably the procedure duration times, levels of anticipation surrounding what the patient may be expecting to happen (especially if pain has been encountered in previous visits) and affect resource utilisation strategies within the clinical facility. With the increasing number of venous ulcers being treated questions can be raised about the ability of healthcare professionals to meet, for example, CQUIN wound care goals with the additional timings required for routine but essential procedures such as debridement4.
Having access to a proven, rapid onset, multimodal anaesthetic gel with additional bacterial agents and adrenaline such as Medi-Solfen® allows faster turnaround times for debridement procedures within any clinic situation. This will positively impact on clinical resource utilisation initiatives increasing productivity. The rapid onset of effective anaesthesia also offers great benefits to the patient, avoiding previous negative experiences associated with pain and making the overall experience more accommodating to enhance overall compliance with treatment. This also aligns itself to the UK NHS advocating a patient- centred approach, an approach that promotes physical comfort, including pain management5.
In 2013/2014 there were 4.7 surgical admissions in England which represents a 27% increase since 2003/2004. Specialists with the highest activity include general surgery 1.3m, trauma/orthopaedics 1.2m and urology 736,000. The most common procedures were hernia repair (all forms) 120,000, hip replacement 116,000, knee replacement 82,000, gall bladder removal 76,000 and tonsillectomy 51,000. Emergency laparotomies are estimated to be 30,000-50,000 per annum1. According to the latest data from the National Centre for Health Statistics, 48 million surgical inpatient procedures were performed in the United States in 20092.
Post-operative acute pain management is a major health issue and is costly to the health care system3. Pain contributes to poor quality of life, reduced well-being, physical disability and mortality4. One source of pain includes surgical procedures.
Unrelieved postsurgical pain is common and may be a useful context in which to study pain- related morbidity and mortality. For example, postoperative pain in hip fracture patients predicted longer hospital length of stay (LOS), delayed ambulation and long-term functional impairment5. Local anaesthetic (LA) infiltration prior to surgical incision closure is a frequently used technique in the operating room. The technique of injecting local anaesthetics into the various layers of the surgical incision (wound) is also a commonly used practice in general anaesthesia surgical cases6. Surgical wound infiltration with local anaesthetics has continued to increase in popularity since the mid 1990’s7. It is relatively inexpensive, technically not difficult and may potentially reduce the post-operative discomfort7.
Even though pain results from complex physiologic mechanisms that involve multiple receptors in both the central and peripheral nervous systems, single or monotherapy with opioids has been a foundation of postsurgical pain management. However, no single analgesic targets all types of pain receptors or signalling pathways; furthermore, the amount of opioids that can be administered is limited due to the risk for adverse drug events that lead to patient discomfort, delayed recovery, prolonged LOS, and increased costs8.
The use of multimodal analgesia involves the administration of two or more analgesic agents that act through different mechanisms with the goal of improving postsurgical pain management.
Non-opioid alternatives, e.g. NSAIDs, acetaminophen, and local anaesthetics are recognized as effective components of a multimodal pain regimen postoperatively. A multimodal approach can reduce opioid use and opioid-related adverse drug events and also result in earlier patient ambulation as well as discharge. Professional guidelines endorse the use of multimodal therapies which should be individualised for the particular patient, operation and circumstances. Understanding of both the range of available interventions and considering the type of surgical procedure are essential to safe and effective pain management. (Veterans Administration/Department of Defence (VA/DoD) Clinical Practice Guideline for the Management of Postoperative Pain). The guidelines also state that the selection of a pain management option should be determined by balancing the advantages, disadvantages, contraindications, as well as patient preference. For most patients, more than one modality will be needed for successful pain management.
Examples of local anaesthetics that are commonly infiltrated include moderate duration agents such as lidocaine, Mepivacaine and Prilocaine and long duration agents such as Bupivacaine and Etidocaine9. Local infiltration may however cause a haematoma to form if the needle damages a blood vessel. Other methods include use of a catheter to infuse local anaesthetic post operatively. This can be done through a catheter laid directly in the wound, or by a catheter placed in a key nerve region nearby (such as a paravertebral catheter placed at thoracotomy to block intercostal nerves at multiple levels). The catheter may stay 2 or 3 days after surgery. There are potential risks with this which include failure of the catheter to sit in the right spot and therefore be ineffective at delivering the local anaesthetic to the regional nerves, risk of infection tracking along the catheter track, or even the catheter being inadvertently retained by a wound closure suture passing through it (meaning re-operation to release the catheter).
Medi-Solfen® offers the surgeon a product that contains all of the components of multimodal therapy in one very simple to apply gel negating the need for individual injections associated with multimodal anaesthetic therapy. Medi-Solfen® is a sterile, cutaneous gel containing four well established active ingredients; lidocaine hydrochloride 5%w/w (equivalent to 4% lidocaine), 0.5%w/w bupivacaine hydrochloride, 0.00451%w/w adrenaline acid tartrate and 0.5%w/w cetrimide in a fixed combination product. As the active ingredients are well- established as local anaesthetics (lidocaine and bupivacaine), as a vasoconstrictor (adrenaline) and as an antiseptic (cetrimide) it offers a unique combination of ingredients not found together in any other product. Use of an agent like Medi-Solfen® can avoid the complications previously highlighted associated with the use of needles. These include no risk of haematoma from use of a needle for infiltration, no swelling of tissues from the volume of local anaesthetic injected around the wound, no catheter to need precise placement or to act as a hazardous foreign body. Additionally the application of Medi-Solfen® directly in onto the wound during closure may act as a “depot” for continued release of the local anaesthetic from the gel for a few hours afterwards.
Wounds heal faster when debrided often by trained healthcare professionals. Published studies have shown that faster and more complete healing was achieved with more frequent debridement regardless of wound type, size or duration1,2. Weekly or even more frequent debridement resulted in shorter healing times compared with less frequent debridement. Education and training for proper debridement practices should not be limited to physicians but should include general staff members in order to make the flow of wound care more efficient. Nearly twice as many Venous Leg Ulcer’s and Diabetic Foot Ulcer’s healed completely with frequent debridement compared with those treated less frequently (50% v 28%).
The clinical professional has a range of options to achieve debridement and choice will depend on the pain threshold of the patient, type of necrotic tissue and where the patient is being treated. The fastest debridement procedure is sharp debridement usually associated with the use of a scalpel or similar instrument. The gentler approach such as the use of hydrogels may take weeks and many visits to facilitate dressing changes and re-application of the hydrogel and is costly and time consuming. Patients who undergo sharp debridement may feel greater pain than other approaches and this may impact on their compliance to undergo the necessary number of debridements to achieve an optimal wound bed that can start to progress towards healing. Also due to the level of procedural pain they may ask an immediate cessation of treatment at any stage during the process.
The need exists for not only a rapid approach to achieving pain relief immediately before the debridement procedure, but also the provision of sustained pain relief for some hours after completion. Research suggests that Medi-Solfen® offers these benefits and would provide increased compliance to achieve completion of the procedure and an increased willingness to return for future visits if required. The impact on the patient’s quality of life will be heightened if the stalled wound can be moved to an increased trajectory of healing faster. From a clinical perspective sharp debridement in pain free circumstances allows faster and more accurate removal of the appropriate amounts of dead tissue without interference from the patient asking to stop due to unbearable pain levels. Other pharmaceutical approaches to wound pain management can take up to 1 hour to attain the necessary level of anaesthesia prior to surgical intervention which adds to anxiety and stress for the patient anticipating what is coming next!
Patients with chronic leg ulcers describe their experience as challenging and difficult. Patients experience their body as unreliable, which in their daily life means that it may be a source of social embarrassment – and possibly eventual isolation due to symptoms such as bad smell, excess of exudate, and pain.1
There are several types of wound pain but of relevance to the use of Medi-Solfen® is the pain type described as “procedural/operative” which is pain that results from routine procedures such as dressing changes or wound cleansing, or is associated with significant wound interventions, such as biopsies or sharp debridement. Sharp debridement of non-viable tissue is a frequent treatment modality for leg ulcers patients. However, the procedure is not well tolerated and patients will often ask the clinicians to stop before the debridement is completed because of the pain2,3,4
It is possible that patients will deny future consent for the sharp debridement if the first experience was painful. This poses difficulties in providing optimal care and in achieving healing in a timely manner. Delayed healing eventually creates additional costs and deterioration in the patient’s quality of life. Debridement procedures are painful not only during the procedure but hours and days after the procedure as well.
The NHS aims at providing patients with a positive experience of the health system, of physical comfort and advocates emotional support and alleviation of fear and anxiety about such issues as clinical status and its treatment5. In this perspective one could say that management of pain is a marker of the quality of care and a way of improving people’s when the wound did not hurt. When patients felt an ease or absence of pain they interpreted it as a positive sign of wound healing, which made them feel hopeful and optimistic6. Pain measurement within the holistic process of quantifying impact on a patient’s quality of life could and probably will become a key goal for future initiatives.
In the UK there are 135 emergency units1. Within England the number of attendances in 2016 was 23.7m2 (65% attending Major Emergency Departments). In 2001, the Department of Health published the paper Reforming emergency care3 and introduced a compulsory national target for England. The target required that by 2004 no-one should wait more than 4 hours in the Emergency Department. In December 2017 just 85.1% of patients at A&E were seen within 4 hours. The figures are even worse for what the NHS calls Type 1 A&E Departments – a Consultant led 24 hour service with full resuscitation facilities and designated accommodation for emergency patients – where just 77.3 per cent of patients were seen within 4 hours4. This time limit produced significant changes in the way many departments and hospitals dealt with their workload in the Emergency Department, and included many initiatives to reduce the total time and redirect patients with low acuity to alternative healthcare providers. One of the most noteworthy changes was the review of the process of “triage” and the change of the primary objective of triage—to allocate the patient to the most appropriate practitioner or area within the healthcare system, thus producing different streams or queues of patients waiting for dedicated teams of workers5.
Emergency care providers have developed a high level of expertise in acute wound management. As an example over 703,000 lacerations presented in UK Emergency Departments between 2015 In the case of this wound type considerations must be given to assessment, irrigation and closure techniques. No single approach can be applied to all wounds; however, a systematic approach to acute wound care integrated with current best practices can provide the framework for exceptional wound management. During the treatment pathway associated with laceration management it may be necessary to administer local anaesthetics to the injured site. While there are numerous commercially available topical anaesthetic agents, most of these require 10 to 30 min to become effective. The combination of lidocaine/prilocaine may have a delayed onset of 1 to 2 h ]. If a more rapid anaesthetic response is needed, injectable lidocaine (1%), bupivicaine (0.25%), or procaine (1%) are commonly used. While these drugs remain the mainstay of anaesthesia for cutaneous repair, the associated pain on injection remains a major drawback6.
Of relevance to the benefits associated with the use of Medi-Solfen®, rapid pain relief following application to traumatic wounds at initial triage and assessment would help patients better manage their extended wait periods before consultation with Lead Clinical Professionals. Once in the presence of the attending Physician, the rapid onset of additional anaesthesia (if required) without using the potential painful technique of fluid injection prior to debridement, irrigation and subsequent closure again offers measureable patient benefits. The product could also be re-applied prior to surgical closure if considered clinically necessary. The same approach could be made with minor painful wounds that present, especially in children.
An essential component of the Emergency Services is the rapid response vehicles (ambulances) that transfer patients from the site of injury to the Accident and Emergency Department. It is estimated in the UK there are close to 5,000 vehicles of this kind. This does not include Emergency Responders or the Air Ambulance Service. The inclusion of Medi-Solfen® within emergency vehicles could provide a valuable option to achieve rapid pain relief to appropriate breaks in the skin during treatment at the site of injury, transfer to hospital and provide anaesthetic cover during the reported ever increasing wait times prior to hand over to the hospital-based team.
The recent wars in Iraq and Afghanistan have helped to shape the modern Defence Medical Services. Over the course of these conflicts there were a number of incremental innovations and improvements in clinical techniques and attitudes that contributed to the overall effect of reducing the mortality from combat injury. Significant resources were allocated to prepare for and deliver a coherent plan for deployed trauma care. The medical advances during the recent conflicts in these parts of the world have also included advances in anaesthesia and analgesia, but to a lesser extent than in other areas. The priority has so far been on improving survival rates. The humanitarian and physiological consequences of analgesia have featured less highly on the priority list.
Presently, with the level of small arms and fragment protection that is issued to Armed Forces, the survival rate following combat trauma is approximately 98%; however, there has been an increase in the number of extremity, groin, and facial wounds, as these are areas that are not as well shielded by individual combat armour1. Many of the concerns and obstacles faced by early anaesthesia providers continue to exist today. The needs for safety, rapid application to surface injuries, mobility and availability of logistical resupply are all concerns for military anaesthesia providers.
The ideal analgesic for military use should have a predictable action, no side effects, a long duration of action, a readily available antidote, be easily administered and be easily stored and transported2.
A Combat Medic will typically carry a backpack styled bag known as a “Unit One Pack”. Aid bags are available from many different manufacturers, in many different styles. Depending on the unit and their standard operating procedures, the Medic may have to follow a strict packing list, or may have the liberty of choosing their kit depending on the mission at hand. In terms of analgesics a typical aid bag will include: Morphine, Naproxen and some OTC products such as Acetaminophen and Ibuprofen3. Depending on the injury pain control may involve a combination of simple measures and different drugs. Morphine auto-injectors are issued to many countries’ armed forces on operations. All UK soldiers receive ample training on the use of the morphine auto-injector. Confidence in using the device is high and generally knowledge is good4. Unwanted side effects associated with Morphine use include respiratory depression, constipation and constriction of the pupils of the eye all of which may affect overall performance in combat situations. The goal in a casualty with mild-to- moderate pain is to provide pain relief that does not affect their sensorium. This allows them to either continue to facilitate their mission set or to help facilitate their own medical care and evacuation, depending on circumstances. In the wilderness setting, this would, in particular, apply to the casualties being able to facilitate their own evacuation5. The respiratory depression that is associated with opiate administration may result in the casualty requiring airway support, greatly complicating any movement.
Wound infection following combat injury is a cause of significant morbidity and occasional mortality6. Combat injury is often filthy, with ingrained dirt containing many troublesome microbes, both bacterial and fungal. These sow the seed for problems which may continue for many years after the injury7. Currently there is no provision for the delivery of any topical antimicrobial agents prior to the arrival of the patient at the Field Hospital.
Now that the survival rate has significantly improved following combat injury, perhaps now is the time to concentrate more effort into the humanitarian and other physiological effects of better anaesthesia, as well as ways of reducing the wound infection rate.
Medi-Solfen® offers the potential for a safe, effective replacement for Morphine that can both be easily and quickly applied and have immediate effect. It is important that delivery of these multi-modal anaesthetics has minimal psychoactive effects so that patients can continue to assist in their own care, evacuation and defence. An additional major benefit offered is that these drugs would act only at the wound site and not systemically. The inclusion of adrenaline into the overall formulation could also have a beneficial effect in controlling surface bleeding. Compared with opiates, which are Controlled Substances and Accountable Items, it would be relatively easy to envisage every soldier carrying an application of Medi-Solfen® in his first aid kit. Cost is also a factor in what medications are carried and utilized. Generic non-prescription medications such as Acetaminophen and Ibuprofen are available at minimal cost, whereas morphine injectors are much more expensive. There is also much less potential for criminal abuse of an item such as Medi-Solfen, unlike opiates. The logistics of the issuing of Medi-Solfen should therefore be much less onerous. The individual provider will need to decide which analgesics he or she should carry based on cost as well as regulatory and standard care pathway considerations.
In addition to military conflicts disaster situations, such as earthquakes, floods, conflicts, might happen in areas where access to a regular hospital or treatment centres might be hours away or not available at all. The provision of effective analgesia for mass casualties needs to be simple in its scope and application, supporting the principle of providing the greatest good for the greatest number in the safest way. The care of wounded victims, and the building or rebuilding of medical and first-aid facilities falls to the role of humanitarian assistance and disaster relief agencies such as the United Nations, Medecins Sans Frontieres and the IRC. These agencies are funded by donations and/or government funding and grants. Similar to the military, all of these agencies source and supply basic medical necessities to their Field Officers for the management of wounded victims and for the setting up of basic medical facilities. A product like Medi-Solfen® has the potential to become a critical component of the basic medicines supplied. It is ideally suited to such applications because it is cheap, portable and able to be applied immediately by rapidly trained lay personnel. It would provide a means of promptly treating wounds that otherwise may remain untended for prolonged periods of time particularly in war-torn or third-world countries. Indeed in many cases such wounds may not receive any other anaesthetic. The monitoring of such casualties may need to rely on minimally trained personnel using simple clinical parameters. When casualties present in large numbers with minor injuries resulting in breakdown of the skin Medi-Solfen can provide an effective rapid solution to pain relief during potential long waits for initial triage or allow casualties to return for later treatment if not in imminent danger. The benefits of having a cheap, simple to use product to relieve pain, minimise bleeding and protect against infection in these circumstances are considerable. Medi-Solfen® has the potential to act as the ‘front line’ pain relief for topical wound care product for victims of trauma throughout the world.