Clinical trial NCT01050673: Trial of Versajet Compared With Conventional Treatment in Acute and Chronic Wounds
Official title: A Study to Investigate the Time to Closure of Delayed Healing Dehisced Incisions, Delayed Healing Traumatic Wounds or Chronic Cutaneous Defects Surgically Excised With VERSAJET Compared Conventional Operating Room Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Dehiscence
Keywords: VERSAJET hydro-surgical debridement
traumatic wound
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques.
timeFrame: 28 days plus 6 week follow-up
Secondary outcomes:
measure: Time of Actual Excision Procedure
timeFrame: 28 days
measure: Cost Per Operative Procedure
timeFrame: 28 days
measure: Cost of Reference Wound-related Surgical Procedures to Achieve Closure
timeFrame: 28 days
measure: Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure
timeFrame: 28 days
measure: Percentage of Patients Achieving Stable Closure Within Study Period
timeFrame: 28 days
measure: Length of Hospital Stay (1st Excision to Discharge (Days))
timeFrame: 28 days
measure: Number of Patient's With Wound-related Readmissions
timeFrame: 28 days and 6 week follow up
measure: Number of Patient's With Serious Adverse Events and Relationship to Device
timeFrame: 28 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Robert D Galiano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Attinger CE, Janis JE, Steinberg J, Schwartz J, Al-Attar A, Couch K. Clinical approach to wounds: debridement and wound bed preparation including the use of dressings and wound-healing adjuvants. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):72S-109S. doi: 10.1097/01.prs.0000225470.42514.8f.
citation: Steed DL, Donohoe D, Webster MW, Lindsley L. Effect of extensive debridement and treatment on the healing of diabetic foot ulcers. Diabetic Ulcer Study Group. J Am Coll Surg. 1996 Jul;183(1):61-4.