Surgical Wound Dehiscence
Conditions
Keywords
VERSAJET hydro-surgical debridement, traumatic wound
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.
Interventions
DEVICEVERSAJET
Hydro-surgery debridement
PROCEDUREScalpel or blade
Conventional Surgical Debridement
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques. | 28 days plus 6 week follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Cost Per Operative Procedure | 28 days |
| Cost of Reference Wound-related Surgical Procedures to Achieve Closure | 28 days |
| Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure | 28 days |
| Time of Actual Excision Procedure | 28 days |
| Length of Hospital Stay (1st Excision to Discharge (Days)) | 28 days |
| Number of Patient's With Wound-related Readmissions | 28 days and 6 week follow up |
| Number of Patient's With Serious Adverse Events and Relationship to Device | 28 days |
| Percentage of Patients Achieving Stable Closure Within Study Period | 28 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VERSAJET Excision with VERSAJET™ Hydrosurgery System | 21 |
| Conventional Therapy Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded. | 19 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 4 | 5 |
Baseline characteristics
| Characteristic | Conventional Therapy | VERSAJET | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 21 Participants | 40 Participants |
| Age, Continuous | 57.1 years STANDARD_DEVIATION 13.7 | 52.2 years STANDARD_DEVIATION 15.5 | 54.5 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment United States | 19 participants | 21 participants | 40 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 5 / 21 | 5 / 19 |
Outcome results
Primary
Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques.
Time frame: 28 days plus 6 week follow-up
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| VERSAJET | Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques. | 7 Time (minutes) | Standard Deviation 3.7 |
| Conventional Therapy | Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques. | 15 Time (minutes) | Standard Deviation 8.5 |
Secondary
Cost of Reference Wound-related Surgical Procedures to Achieve Closure
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VERSAJET | Cost of Reference Wound-related Surgical Procedures to Achieve Closure | 13689.1 Dollars ($) | Standard Deviation 8154.3 |
| Conventional Therapy | Cost of Reference Wound-related Surgical Procedures to Achieve Closure | 12869.4 Dollars ($) | Standard Deviation 5703.3 |
Secondary
Cost Per Operative Procedure
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VERSAJET | Cost Per Operative Procedure | 4411.70 Dollars $ | Standard Deviation 2020.2 |
| Conventional Therapy | Cost Per Operative Procedure | 6014.10 Dollars $ | Standard Deviation 4143.3 |
Secondary
Length of Hospital Stay (1st Excision to Discharge (Days))
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| VERSAJET | Length of Hospital Stay (1st Excision to Discharge (Days)) | 39 Days | Standard Deviation 22.6 |
| Conventional Therapy | Length of Hospital Stay (1st Excision to Discharge (Days)) | 38 Days | Standard Deviation 18.7 |
Secondary
Number of Patient's With Serious Adverse Events and Relationship to Device
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VERSAJET | Number of Patient's With Serious Adverse Events and Relationship to Device | 5 Number of patients |
| Conventional Therapy | Number of Patient's With Serious Adverse Events and Relationship to Device | 5 Number of patients |
Secondary
Number of Patient's With Wound-related Readmissions
Time frame: 28 days and 6 week follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VERSAJET | Number of Patient's With Wound-related Readmissions | 1 Number of patients |
| Conventional Therapy | Number of Patient's With Wound-related Readmissions | 0 Number of patients |
Secondary
Percentage of Patients Achieving Stable Closure Within Study Period
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VERSAJET | Percentage of Patients Achieving Stable Closure Within Study Period | 42.9 percentage of patients |
| Conventional Therapy | Percentage of Patients Achieving Stable Closure Within Study Period | 42.1 percentage of patients |
Secondary
Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure
Time frame: 28 days
Population: Pre and post-excision values added, (cfu/g) tissue.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| VERSAJET | Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure | Pre-first excision bacterial count (log10) cfu/g | 4.0 cfu/g | Standard Deviation 2.1 |
| VERSAJET | Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure | Post-first excision bacterial count (log10) cfu/g | 3.2 cfu/g | Standard Deviation 2 |
| Conventional Therapy | Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure | Pre-first excision bacterial count (log10) cfu/g | 4.0 cfu/g | Standard Deviation 1.5 |
| Conventional Therapy | Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure | Post-first excision bacterial count (log10) cfu/g | 3.3 cfu/g | Standard Deviation 1.6 |
Secondary
Time of Actual Excision Procedure
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| VERSAJET | Time of Actual Excision Procedure | 7 Time (Minutes) | Standard Deviation 3.7 |
| Conventional Therapy | Time of Actual Excision Procedure | 15 Time (Minutes) | Standard Deviation 8.5 |