Q&A Chronic wounds and Debrichem Chronic wounds: Indication, standard of care

• • When is a wound called hard-to-heal or chronic? Textbooks refer to chronic wounds when healing is not initiated within 3 to 6 weeks. Some national health authorities extend this period to several months. Chronic wounds affect 1 to 2 % of developed countries’ populations at least once in their lifetime and represent a silent epidemic that affects a large fraction of the world population.

 

• • What impairs healing in chronic wounds? Chronic wounds are caused by a number of internal (such as venous hypertension or neuropathy) and external factors. External factors include the presence of necrosis, which prevents the formation of granulation tissue and subsequent healing and the presence of microorganisms, particularly when they have formed a biofilm, which corrupts the onset of healing.Within the chronic lesion, continuous disruption of the “normal” processes of tissue-remodelling prevents healing.

 

• • Why are chronic wounds so dangerous? Besides being associated with chronic pain, unpleasant smell and social isolation, chronic wounds are the leading cause for amputation, because unsuccessful treatment of difficult to heal wounds may lead to enlargement of the wound, bone involvement and in the worst case, amputation. Amputation is one of the leading causes of premature death, with 1 out of 5 patients dying within a year after the procedure.

 

• • Why is debridement of chronic wounds so important? Debridement of a chronic wound is important to clean the wound bed and restart healing.Often, wounds do not heal due to infection and its protective biofilm in the wound bed. Traditionally, the best way to remove the biofilm and the infection is through debridement of the wound. Debridement should disrupt the biofilm and clear necrotic debris from the wound allowing the natural wound healing to start and develop granulation. Unsuccessful treatment of difficult to heal wounds may lead to enlargement of the wound, bone involvement, or in the worst case, amputation. Amputation is one of the leading causes of premature death, with 1 out of 5 patients dying within a year after the procedure.

 

• • What treatment options are there for chronic wounds, what is the standard of care? Surgical debridement is generally considered the standard of care as it offers the best way to remove the biofilm, because it is quick, rigorous and the most efficacious option available. It is an essential step in getting a chronic wound or ulcer to heal. Other forms of debridement such as topical enzymes, vacuum assisted techniques or larval application are often less effective or require extended treatment periods. However, surgical debridement is expensive and requires both skilled operators and a sterile operating room. The biofilm is not visible to the human eye, which often means that several debridements are needed before the wound start to granulate fully.

  Application and Side Effects:

• • What is Debrichem and what is it used for? Debrichem is a new treatment option for debriding infected chronic wounds. Debrichem is a semifluid or gel-like substance containing the active ingredient methanesulfonic acid. Debrichem offers an alternative to surgical debridement. Debrichem works by desiccating (dehydrating) the biofilm and the pathogens living inside it, thereby reversing chronic wounds into acute wounds and enabling the healing process to start.Treatment with Debrichem removes unhealthy and necrotic tissue as well as the infection and its biofilm present in the wound bed, after which the natural healing process can start.

 

• • Who can use Debrichem? Debrichem should be used by health care professionals only, however in contrast to surgical debridement, it does not require a high level of specialization or a sterile room and can be applied in an ambulatory setting, both by doctors and nurses.

 

• • How is Debrichem used? After undressing and cleaning the wound, Debrichem is applied to the wound bed and 1 cm around the perimeter of the wound. It is then left on the wound for up to 60 seconds. After incubation, the wound is rinsed with sterile or saline water and dressed according to standard of care. After only one treatment with Debrichem, more than 90 % of chronic wounds start healing. To reduce the transient pain during application, healthcare professionals may consider using local anaesthetics when applying Debrichem onto the wound (see IFU).

 

• • Why does one only need to use Debrichem for 60 seconds?

Debrichem is a very powerful agent, the formulation is designed to fully debride the chronic wound within 60 seconds.  

• • How big is the wound area that could be treated with one bottle of Debrichem? One bottle of Debrichem is sufficient to treat a wound area of up to 100 cm². Debrichem has however also been used in wounds larger than 100 cm² in surface area resulting in full granulation in most cases. These larger wounds may require more than one bottle of Debrichem.

 

• • Does one clean the wound before the application of Debrichem and again after? After removing the dressing, the wound should be cleaned like you would normally do before debridement. After 60 seconds post application of Debrichem, it is rinsed off with ample sterile or saline water. It is up to the treatment specialist to clean the wound further to remove debris before dressing.

 

• • How does Debrichem work chemically? Debrichem is an acid with enhanced hygroscopic characteristics, creating a powerful tool to extract water molecules from biologic material like pathogens, their extracellular matrix called biofilm and necrotic debris. This is called desiccation and is used to debride chronic wounds. Due to the low water content, healthy surrounding skin and epidermis are not affected.The chronic wound is cleaned by Debrichem by removing water molecules from the wound bed, disrupting infection and its biofilm. The main reason why Debrichem works is that the micro-organisms in the biofilm and the biofilm itself have a very high water content, up to 95%. The surrounding skin and underlying tissue are not affected because it only contains 30% water leaving a clean wound bed to re-start healing post procedure.

 

• • What are the effects of a treatment with Debrichem? Debrichem desiccates or de-hydrates the organic material in the wound bed. This includes the biofilm and infection present in 78 % of chronic wounds, as well as necrotic material. This form of debridement leaves a clean wound bed in which the healing process can re-start. Furthermore, the pain and smell associated with chronic wounds usually start to ameliorate within 24 hours after treatment with Debrichem.

 

• • Biofilms can grow back within 24 hours of debridement, how come a once-off application of Debrichem suffices? Debrichem treats the infection and its biofilm in the wound. A new infection will have to occur to grow a new biofilm. This is why it is very important to apply Debrichem onto the entire wound itself and include at least 1 cm of the intact perimeter of the wound, to remove any nearby infection as well, and thus prevent contamination. The surrounding intact tissue does not deteriorate during this treatment.

 

• • Is there evidence that the infection is eliminated immediately? In vitro testing shows rapid and complete eradication of the infection and biofilm in wound models, the results of which are currently written up for publication. A video is available on the website which shows the rapid effect of Debrichem on bacteria in their biofilm in the wound care model of the Danish Technological Institute.

 

• • Which data support the use of Debrichem? Initial clinical evidence of the efficacy of Debrichem in chronic wound care is based on a retrospective analysis of a compassionate, real-life study of Debrichem. Additionally, clinical results from more than 50 patients in which full granulation was achieved in 96 % of subjects after 38 days (median) have been submitted for publication in a peer-reviewed journal. The study included a high number of patients with concomitant diseases and/or ulcer types/size that are typically excluded in studies. Regardless, the granulation and re-epithelialisation percentages are high compared to many published trials in chronic lesions. The manuscript currently under review for publication (Cogo A et al and Hermans H.E.).

 

• • Do you plan to collect further clinical evidence? DEBx Medical emphasizes the scientific basis of Debrichem. The Company is currently about to start a controlled clinical trial in a open label, randomised multicentre setting, comparing Debrichem to standard of care debridement. Case studies are ongoing globally awaiting final outome.

 

• • What is the expected chance of healing after the use of Debrichem? There are >1000 wounds treated with Debrichem. Well documented case studies of the more difficult to treat wounds, based on size, etiology and severity have shown that only one application of Debrichem is sufficient to reach full granulation of the wound in more than 90 % of patients, within a median time of 22 days.

 

• • What are the advantages and disadvantages of treatment with Debrichem? The main advantages for patients are:
    • Debrichem offers a fast-acting therapy based on only one application. Patients do not have to undergo repeated, further surgical debridement. In more than 90% of the cases, this one-off procedure is sufficient to establish granulation of the wound. Further cleaning and wound dressing are based on the doctors’ preference.
    • In most cases, wound healing can starts immediately after treatment.
    • Patients experience reduced pain and smell within 24 hours after the procedure.
    The only disadvantage is transient procedural pain that can be treated with a local anaesthetic in the wound bed similar to surgical debridement. Patients suffering from neuropathy are less likely to experience pain.

 

• • Where in the world is Debrichem registered and used? Debrichem has received CE-mark medical device type II certification in Europe and TGA certification in Australia. This means Debrichem can be used in Europe currently and the countries that accept CE-Mark/TGA for approval. Debrichem is used in several European countries, South Africa, Australia, New Zealand and Hong Kong currently.

 

• • Has the FDA approved Debrichem for the US market? Debrichem does not have US FDA approval today. The company is in conversation with the US FDA to decide which route to the US-market is applicable for Debrichem, which will likely include new clinical data from the US.The following questions will have to be answered by the SA team or we will have to wait for case study results or the App to be ready: