Maggot Debridement Therapy
Madeleine Moon (Bridgend, Labour)
I am grateful to have secured this debate, which provides an opportunity, on the eve of St. David's day, to inform the House about the benefits of a highly cost-effective and efficient but forgotten and undervalued method of treatment for wounds, and to expand on the information provided in my early-day motion 993 on the subject.
ZooBiotic, a laboratory in my constituency, produces clinically sterile maggots for medical use. Maggot therapy is a potent tool in the treatment of wounds and a potential weapon in the battle against methicillin-resistant Staphylococcus aureus. Even the most squeamish would not avert their eyes from a potential saving to the NHS of up to £30 million a year—at a conservative estimate—or from a tool that could limit the spread of super-bugs in our hospitals and care homes.
Having worked in health and social services for 25 years, I know how time-consuming and difficult it is to treat patients with chronic wounds, such as diabetic foot ulcers, pressure sores and venous ulcers. Such wounds remain infected for long periods, causing great discomfort, pain and distress. The problem is compounded by the risk of hospital-acquired infection, especially as chronic wounds represent a serious cross-contamination hazard.
Our forebears were well aware of the healing properties of maggots in wounds. Mayan Indians and aboriginal tribes in Australia knew of the therapy. Hon. Members may recall that Russell Crowe's character in "Gladiator" had a wound that was treated with maggots. It was well documented by Napoleon's battlefield surgeon how maggots were used in the treatment of wounds at field hospitals to assist with healing. Other military sources have reported the use of maggots. A medical officer in the American civil war reported that maggots were used to clean more wounds in a single day than a surgeon could achieve and how they saved many lives.
The founder of modern maggot therapy, William Baer, pioneered the use of maggots in hospitals, having observed how wounds infected with maggots that he saw in his hospital in the trenches of the first world war often had clean and fresh flesh underneath once the maggots were removed. However, by the mid-1930s, the use of maggot therapy began to decline as hospitals turned instead to the use of antibiotics, especially penicillin.
Maggots act on a wound by debriding or dissolving necrotic tissue. Many hon. Members have asked me about the subject, intrigued by the therapy. The maggots disinfect the wound by killing bacteria and stimulating wound healing. In the past, sterile maggots have been accepted as a valuable resource and hospitals are again beginning to accept the treatment. Maggots are highly precise in removing only rotting tissue, unlike surgeons, who have to cut away healthy tissue to clean a wound, thereby creating a larger wound with more bleeding. When maggots debride a wound, the source of infection is removed and studies have begun to show that maggots can remove MRSA in wounds. Maggot secretions also appear to stimulate the body's healing mechanism and the micro-massage of the tissue stimulates new growth. There are no significant risks or adverse effects linked to the use of maggots in the treatment of wounds. The maggots are bred to be sterile by ZooBiotic and therefore cannot introduce pathogenic organisms into a wound.
Patients' most common concern is that the maggots will turn into flies but, as they are contained in a sterile dressing that is changed every three or four days, that risk does not exist. Patients also worry that the action of the maggots will be painful. In some instances, however, the healing produced by the maggots can reduce the pain in a wound, and in most cases there is no pain at all. The most significant side effect reported by patients is a slight tickling sensation, while other unpleasant side effects of wound infection, such as odour, are also notably reduced.
The success of the therapy is undisputed, and ZooBiotic estimates that 20 million maggots were supplied over a four-year period, with 64,000 dosage units being applied to 30,000 patients in 3,300 centres in the UK. However, to date there has been no formal, systematic review of the treatment. I therefore want to use this debate to call on the Government to ensure that such a review takes place as soon as possible.
I understand that, initially, people may not feel comfortable with using maggots in wound therapy, and that they might consider it a retrograde step in this technological age. However, people have telephoned me in my office—and I know that some have even sent their personal testimonies to other hon. Members—to tell me about how the therapy has been used effectively to treat members of their family. A review would be invaluable in allaying any negative public perception of the treatment. It would also help to broadcast the treatment's success to medical and health care practitioners.
ZooBiotic has a state-of-the-art, sterile pharmaceutical unit, in which the "LarvE" brand of sterile maggots is produced. The maggots are bred to be slightly larger than normal: they are more active, and therefore more effective.
There are two techniques of debridement therapy. The first technique involves using free-range maggots—I apologise for the use of the term—in infected wounds with especially deep cavities, and the second involves applying a sealed dressing to the wound. The dressing is best described as looking somewhat like a tea bag, and it contains chips of a product called BioFOAM to provide a physical environment that stimulates the maggots' activity and development. BioFOAM makes maggot therapy more efficient and practical, and more palatable for modern use. It also makes maggot therapy easier for nurses to apply, and more acceptable to patients.
Maggot therapy is highly successful, and highly cost effective. Approximately 650,000 wounds are treated every year, at an estimated cost to the NHS of about £3 billion. Only 5 per cent. of those costs are product-related; the rest is due to the amount of staff time required over the course of the often protracted treatment that the wounds need, so any therapy that reduces treatment times will deliver cost benefits to the NHS. The average time to clean a wound by conventional means is 89 days, but maggot therapy can reduce that to as little as five days. It is calculated that reducing treatment times and materials costs could result in an annual saving to the NHS of around £160 million.
Maggots cannot be applied to all wounds. However, if they were applied in only 10 or 20 per cent. of wounds, at least £15 million to £30 million could be saved—a significant sum in the health service's stretched budget.
The second action of maggots—disinfecting the wound by killing bacteria—brings additional benefits. Again, I feel that I must urge the Government to ensure that clinical trials are held to maximise the therapy's potential. A report produced by the National Audit Office showed that, at any given time, some 9 per cent. of hospital patients have a hospital-acquired infection. Such infections cost the NHS as much as £1 billion per annum and can contribute to the death of an estimated 5,000 people a year. The organism most frequently responsible for hospital-acquired infection is MRSA, and maggot therapy offers a solution to that problem.
Clinical trials are required to prove the effectiveness of the therapy. Preliminary trials have been conducted in the biological research unit at the Princess of Wales hospital in my constituency on five patients with MRSA-infected wounds that were not responding to conventional treatment. In each case, treatment with maggots cleansed the wounds, eliminated the MRSA and allowed healing to commence, on average, in four days. A study carried out at the Manchester royal infirmary showed that maggot therapy reduced problems for 12 in 13 cases of ulcers colonised by MRSA. Preliminary laboratory studies have shown that maggot secretions are active against MRSA, and although the research is based on a narrow field, the results suggest that the potential for maggot therapy as an additional weapon in the fight against MRSA and in the reduction of antibiotic use cannot be overlooked.
I hope that I have been able to highlight some of the compelling evidence of the effectiveness and cost benefits of maggot therapy, and that the Government will respond with appropriate examination of the treatment opportunities for patients who have some of the most difficult, painful and life-threatening conditions. That examination should be complemented by funds for research into maggot therapy so that patients can benefit from its utilisation. We can combat the super-bugs and—I hope—the weak, the frail and the vulnerable will benefit.
A nurses' study of patients' perceptions of maggot therapy revealed that initial feelings of revulsion at the thought of using maggots in a wound—about which a number of people have talked to me, too—gave way to feelings of hope once people saw how effective the treatment was. This is not a time to be squeamish or to look away from the serious problems in our hospitals. I hope that after the debate I shall be able to invite my hon. Friend the Minister to visit ZooBiotic to see for herself how the company has brought maggot therapy into the 21st century, primed for use in modern medicine for modern patients.
Caroline Flint (Minister of State (Public Health), Department of Health; Don Valley, Labour)
I congratulate my hon. Friend Mrs. Moon on securing the debate. She has chosen an illuminating topic. In this era of advanced technology and medicine, she has shown us that there may be a place for treatments and therapies that have been around for hundreds of years. As she said, the term "maggot debridement" conjures up all kinds of images—often making people recoil in horror at the very thought. However, as she has pointed out, there appear to be some real merits in the practice, which, in the absence of other treatments, had some success for many hundreds of years.
The practice is becoming increasingly popular, particularly in cases where patients may have special clinical needs that cannot be met by licensed medicinal products; for example, elderly patients for whom anaesthetic could pose a real risk or patients who may be allergic to the types of antibiotic that would usually be prescribed for their condition. We have to remember the basic fact that these are real situations, involving real people—members of our families—who really need that element of choice in their treatment. The availability of maggot debridement as an alternative for such groups of patients is of considerable importance, but there must be sensitive engagement with those individuals and their families to reassure them that it is worth having the treatment.
People may see maggots as the antithesis of health, considering them as harbourers of bacteria, but those maggots emerge from eggs laid by flies on rubbish or rotting meat in a dirty environment where they are riddled with germs. Like my hon. Friend, I emphasise the fact that the maggots used in the procedures we are discussing are surgical-grade fly larvae. They are bred specifically for medical purposes from sterilised eggs in strictly controlled laboratory procedures. Not all types of maggot can be used, as some not only eat dead tissue but feed on healthy living tissue as well.
We are acutely aware that most of the literature on maggot therapy to date is anecdotal, so I completely understand why people would have concerns or be reluctant to take part in such treatment. In the absence of sufficient evidence for or against any particular method of debridement or for one type of modern dressing over another, the choice of debriding agent for difficult-to-heal surgical wounds should be based on impact, comfort, odour control and other aspects relevant to patient acceptability, type and location of wound and, of course, total cost. I listened very carefully to what my hon. Friend said about the potential cost savings of an effective treatment.
Clearly, patients and their carers should participate in the management of their wounds through shared decision making, including on choice of dressing, and in some instances by sharing the care of the wound after appropriate education advice. As my hon. Friend suggested, where a treatment has potential, it is important to think about providing some support for relevant clinical trials to take the idea further—possibly forward to a future where it could be used more commonly within our national health service.
We want to ensure that there is proper and robust evidence that the procedures we are using are effective, which is why the Department of Health is currently funding a major study in this area by the university of York. That study will also establish the cost-effectiveness of the maggot therapy. The researchers are looking into treating wounds with two different methods of application. The first is applying maggots loose to the wound and applying a light dressing, and the second is where the maggots are contained in a very fine mesh bag—something akin to a teabag, I understand, but not for that use afterwards, I hasten to add. The theory is that they can still clean the wound through the material without being able to work their way through it themselves. The study is also assessing the impact of larval therapy on wound microbiology, including MRSA, and the acceptability of the treatment for patients. The report of that research is expected early in 2009.
As the use of maggot debridement therapy is already reasonably well established in hospitals for the treatment of chronic ulcers, there is no real reason why it should not be indicated for MRSA-infected or colonised ulcers. The use of maggot debridement therapy must form part of a team effort, involving the infection control team, the tissue viability nurse and possibly input from plastic surgeons or other clinicians with wound healing expertise. Additional treatment, including relevant systemic antibiotics, would also be necessary.
According to a NICE guideline issued in 2001, there are a number of different methods of debridement, of which bio-surgical use of sterile maggots is one. I should like to pay a little attention to the regulatory position. I understand that, in 2001, the European committee that issues guidance and opinions on medicines licensing issues took the view that, when used to treat soft tissue infections or remove damaged tissue, maggots potentially fall into the definition of a medicinal product. In order to get a licence to market maggots as a medicine, a manufacturer would need to submit all relevant data, including those from extensive clinical trials, to the regulator. The Medicines and Healthcare products Regulatory Agency has not yet received an application for such a licence, but such an application would be welcome.
However, I am aware that clinical trials on the medical use of maggots are currently under way. Clinical trials are required by law and it is essential in medicines development to evaluate the quality, safety and efficacy of the product. In the UK, the medicines regulator is the MHRA, which authorises all clinical trials that take place in the UK, including the one under way, with support from the Department of Health, at the university of York.
Some patients might have clinical needs that cannot be met by licensed medicinal products. In order to meet those needs, the law allows the special use of unlicensed medicines, subject to certain conditions. These are that the product should be supplied in response to an unsolicited order from a UK-registered doctor or other authorised prescriber, that it should be used to treat that prescriber's individual patient, and that it should be formulated in accordance with the prescriber's requirements and used on the prescriber's direct personal responsibility.
ZooBiotic Ltd, in my hon. Friend's constituency, currently holds a manufacturer's "specials" licence to produce maggots for this purpose. This type of licence authorises the site to manufacture unlicensed medicinal products in compliance with medicines legislation, including good manufacturing practice. It does not, however, allow the company to market the product more widely. ZooBiotic also holds a licence to produce sterile maggots for use in clinical trials. The site is licensed and inspected by the MHRA.
In summary, maggot therapy is a recognised form of treatment for wound infections. Local trusts and clinical teams should apply the NICE guidance on the use of debriding agents and specialist wound care clinics for difficult-to-heal surgical wounds to individual cases, in discussion with patients and their families. I have outlined the work being undertaken by the university of York, which put out a press release on
Question put and agreed to.
Adjourned accordingly at twenty minutes to Eight o'clock.