Surgical Wound DehiscenceNCT01050673
Trial of Versajet Compared With Conventional Treatment in Acute and Chronic Wounds
A study testing VERSAJET and Scalpel or blade in people with Surgical Wound Dehiscence, run by Smith & Nephew, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Dehiscence
- What is being tested?
- VERSAJET and Scalpel or blade
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Surgical Wound Dehiscence
- Being tested
- VERSAJET, Scalpel or blade
- Keywords
- VERSAJET hydro-surgical debridement, traumatic wound
- Medical subject headings
- Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERSAJETDevice
Hydro-surgery debridement
Scalpel or bladeProcedure or surgery
Conventional Surgical Debridement
| Study group | Role | What they receive |
|---|---|---|
| VERSAJET | Active comparator | Excision with VERSAJET™ Hydrosurgery System Receives: Device: VERSAJET |
| Conventional Therapy | Active comparator | 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. Receives: Procedure: Scalpel or blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques.
Measured: 28 days plus 6 week follow-up
Secondary outcomes (8)
Time of Actual Excision Procedure
Measured: 28 days
Cost Per Operative Procedure
Measured: 28 days
Cost of Reference Wound-related Surgical Procedures to Achieve Closure
Measured: 28 days
Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure
Measured: 28 days
Percentage of Patients Achieving Stable Closure Within Study Period
Measured: 28 days
Length of Hospital Stay (1st Excision to Discharge (Days))
Measured: 28 days
Number of Patient's With Wound-related Readmissions
Measured: 28 days and 6 week follow up
Number of Patient's With Serious Adverse Events and Relationship to Device
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startNov 2007
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound DehiscenceStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert D Galiano, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050673
- Sponsor's protocol ID
- CE/030/VJT
- Status last verified
- Feb 2018
- First submitted
- 13 Jan 2010
- Last updated
- 12 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16799376Steed 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.
PubMed 8673309
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01050673
- Acronym / sponsor ID
- CE/030/VJT
- Conditions
- Surgical Wound Dehiscence
- Keywords
- VERSAJET hydro-surgical debridement, traumatic wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 8 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VERSAJET | Active comparator | Device: VERSAJETExcision with VERSAJET™ Hydrosurgery System |
| Conventional Therapy | Active comparator | Procedure: Scalpel or bladeConventional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VERSAJETHydro-surgery debridement | Device | VERSAJET |
| Scalpel or bladeConventional Surgical Debridement | Procedure or surgery | Conventional Therapy |
Primary outcome
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
8 secondary outcomes
Time of Actual Excision Procedure
Time frame: 28 days
Cost Per Operative Procedure
Time frame: 28 days
Cost of Reference Wound-related Surgical Procedures to Achieve Closure
Time frame: 28 days
Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure
Time frame: 28 days
Percentage of Patients Achieving Stable Closure Within Study Period
Time frame: 28 days
Length of Hospital Stay (1st Excision to Discharge (Days))
Time frame: 28 days
Number of Patient's With Wound-related Readmissions
Time frame: 28 days and 6 week follow up
Number of Patient's With Serious Adverse Events and Relationship to Device
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16799376Attinger 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.
- Background: PubMed 8673309Steed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Galiano, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VERSAJET and Scalpel or blade in people with Surgical Wound Dehiscence, run by Smith & Nephew, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01050673, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.