Trial of Versajet Compared With Conventional Treatment in Acute and Chronic Wounds

It is increasingly recognised that the debridement of devitalised, bacterially contaminated
or senescent tissue is an essential component of the effective treatment of delayed healing
wounds. Whilst passive autolytic or enzymatic debridement procedures have their place, where
patients are unable to tolerate any surgical procedure, the judicious use of surgical
debridement to rapidly remove necrotic, contaminated tissue and slough has been shown to
offer many advantages in returning a wound to a healing trajectory.

Whilst surgical debridement procedures have conventionally been performed with scalpels and
other sharp instrumentation, alternative techniques such as the VERSAJET Hydrosurgery System
are becoming more widespread.

To increase the adoption of this new technology, it is essential that clinical improvements
are assessed alongside the potential impact on the costs of debridement and the net financial
impact on the hospital. In fiscal year 2004, there were more than 57,000 discharges under DRG
code 217 ('wound debridement and skin graft except hand) in the United States. Mean length of
stay (all payers) was 11 days and mean charges were $52,800. In 2005, Medicare funded 15,800
discharges under this code. Average charges for these patients were $56,500 and average
reimbursement was $18,2654. In this context it is particularly important that the potential
patient benefit and cost impact of new technology is fully assessed.

It is hypothesised that a decrease in the time to achieve stable wound closure will not only
lead to a patient benefit, but also a potential reduction in the cost of treatment due to
e.g. repeat procedures, longer hospital stay, infection etc. The purpose of this study is to
investigate the difference in time to closure of wounds surgically excised with VERSAJET
Hydrosurgery System and those surgically excised using conventional operating room
techniques.

Inclusion Criteria:

- Patients aged 18 years and older

- Male, and female patients (provided they are not pregnant and if of reproductive age
are using contraception)

- Patients with a delayed healing traumatic wound or chronic cutaneous defect of 30 days
or more in duration, or a delayed healing dehisced incision that requires excision to
remove necrotic or infected tissue

- Patients who are deemed to require closure by primary intention or definitive cover
with an autologous split-thickness skin graft (STSG) or flap

- Patients who are hospital in-patients, or will be an in-patient for the period of 1st
excision to closure

- Patients deemed suitable for debridement with both VERSAJET Hydrosurgery System and
conventional operating room techniques

- Patients undergoing surgical excision of their reference wound in the operating room
(OR)

- Patients able to understand the evaluation and willing to consent to the evaluation

Exclusion Criteria:

- Patients who have previously undergone surgical excision of the reference wound by the
Principal Investigator in the last 30 days

- Patients with coagulopathy (including those with haemophilia)

- Patients with vasculitis, non-reconstructive peripheral vascular disease, pyoderma
granulosa, renal failure or lymphoedema

- Patients with irradiated, burn or ischaemic wounds

- Patients with a BMI >35

- Patients deemed to require a staged procedure, with hospital discharge occurring
between procedures

- Patients deemed to require biological dressings / skin substitutes

- Patients for whom wound healing by secondary intention is deemed necessary

- Patients who have been treated with systemic immunosuppressants (including
corticosteroids), or cytotoxic chemotherapy in the last 30 days, or who are
anticipated to require such medications during the course of the study

- Patients known to have Acquired Immunodeficiency Syndrome (AIDS) or known to be
infected with Human Immunodeficiency Virus (HIV)

- Patients with a known history of poor compliance with medical treatment

- Patients who have participated in this evaluation previously or who are currently
participating in another clinical study