search
Back to results

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

Primary Purpose

Surgical Wound Dehiscence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VERSAJET
Scalpel or blade
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound Dehiscence focused on measuring VERSAJET hydro-surgical debridement, traumatic wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

VERSAJET

Conventional Therapy

Arm Description

Excision with VERSAJET™ Hydrosurgery System

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.

Outcomes

Primary Outcome Measures

Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques.

Secondary Outcome Measures

Time of Actual Excision Procedure
Cost Per Operative Procedure
Cost of Reference Wound-related Surgical Procedures to Achieve Closure
Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure
Percentage of Patients Achieving Stable Closure Within Study Period
Length of Hospital Stay (1st Excision to Discharge (Days))
Number of Patient's With Wound-related Readmissions
Number of Patient's With Serious Adverse Events and Relationship to Device

Full Information

First Posted
January 13, 2010
Last Updated
February 12, 2018
Sponsor
Smith & Nephew, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01050673
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Dehiscence
Keywords
VERSAJET hydro-surgical debridement, traumatic wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VERSAJET
Arm Type
Active Comparator
Arm Description
Excision with VERSAJET™ Hydrosurgery System
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VERSAJET
Intervention Description
Hydro-surgery debridement
Intervention Type
Procedure
Intervention Name(s)
Scalpel or blade
Intervention Description
Conventional Surgical Debridement
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Time of Actual Excision Procedure
Time Frame
28 days
Title
Cost Per Operative Procedure
Time Frame
28 days
Title
Cost of Reference Wound-related Surgical Procedures to Achieve Closure
Time Frame
28 days
Title
Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure
Time Frame
28 days
Title
Percentage of Patients Achieving Stable Closure Within Study Period
Time Frame
28 days
Title
Length of Hospital Stay (1st Excision to Discharge (Days))
Time Frame
28 days
Title
Number of Patient's With Wound-related Readmissions
Time Frame
28 days and 6 week follow up
Title
Number of Patient's With Serious Adverse Events and Relationship to Device
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D Galiano, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16799376
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.
Results Reference
background
PubMed Identifier
8673309
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs