N/A
N=40
Trial of Versajet Compared With Conventional Treatment in Acute and Chronic Wounds
Surgical Wound Dehiscence
Bottom Line
View on ClinicalTrials.gov: NCT01050673 ↗Enrolled (actual)
40
Serious AEs
25.0%
Results posted
Oct 2012
Primary outcome: Primary: Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques. — 7; 15 Time (minutes)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VERSAJET (Device); Scalpel or blade (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques. |
7; 15 | — |
| SECONDARY Time of Actual Excision Procedure |
7; 15 | — |
| SECONDARY Cost Per Operative Procedure |
4411.70; 6014.10 | — |
| SECONDARY Cost of Reference Wound-related Surgical Procedures to Achieve Closure |
13689.1; 12869.4 | — |
| SECONDARY Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure |
4.0; 4.0; 3.2; 3.3 | — |
| SECONDARY Percentage of Patients Achieving Stable Closure Within Study Period |
42.9; 42.1 | — |
| SECONDARY Length of Hospital Stay (1st Excision to Discharge (Days)) |
39; 38 | — |
| SECONDARY Number of Patient's With Wound-related Readmissions |
1; 0 | — |
| SECONDARY Number of Patient's With Serious Adverse Events and Relationship to Device |
5; 5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01050673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.