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

NCT01050673 | Completed Results

• 1 other identifier: CE/030/VJT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Dehiscence

Keywords

VERSAJET hydro-surgical debridement; traumatic wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Time of Actual Excision Procedure

  28 days

• 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

• Percentage of Patients Achieving Stable Closure Within Study Period

  28 days

Study Arms (2)

VERSAJET

ACTIVE COMPARATOR

Excision with VERSAJET™ Hydrosurgery System

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.

Procedure: Scalpel or blade

Interventions

VERSAJET DEVICE

Hydro-surgery debridement

VERSAJET

Scalpel or blade PROCEDURE

Conventional Surgical Debridement

Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• 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.

  PMID: 16799376 BACKGROUND

• 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.

  PMID: 8673309 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Robert D Galiano, Assistant Professor of Surgery
• Organization: Northwestern Medical Faculty Foundation

rgaliano@nmh.org

312-695-6022

Study Officials

• Robert D Galiano, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: November 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 12, 2018
• Results First Posted: October 8, 2012

Record last verified: 2018-02

Locations

US (1)