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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew Wound Management Inc
ClinicalTrials.gov Identifier:
NCT01050673
First received: January 13, 2010
Last updated: September 7, 2012
Last verified: September 2012
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Surgical Wound Dehiscence
Interventions: Device: VERSAJET
Procedure: Scalpel or blade

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
VERSAJET Excision with VERSAJET™ Hydrosurgery System
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.

Participant Flow:   Overall Study
    VERSAJET     Conventional Therapy  
STARTED     21     19  
COMPLETED     17     14  
NOT COMPLETED     4     5  
Physician Decision                 4                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
VERSAJET Excision with VERSAJET™ Hydrosurgery System
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.
Total Total of all reporting groups

Baseline Measures
    VERSAJET     Conventional Therapy     Total  
Number of Participants  
[units: participants]
  21     19     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     19     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  52.2  ± 15.5     57.1  ± 13.7     54.5  ± 14.7  
Gender  
[units: participants]
     
Female     5     9     14  
Male     16     10     26  
Region of Enrollment  
[units: participants]
     
United States     21     19     40  



  Outcome Measures
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1.  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 ]

2.  Secondary:   Time of Actual Excision Procedure   [ Time Frame: 28 days ]

3.  Secondary:   Cost Per Operative Procedure   [ Time Frame: 28 days ]

4.  Secondary:   Cost of Reference Wound-related Surgical Procedures to Achieve Closure   [ Time Frame: 28 days ]

5.  Secondary:   Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure   [ Time Frame: 28 days ]

6.  Secondary:   Percentage of Patients Achieving Stable Closure Within Study Period   [ Time Frame: 28 days ]

7.  Secondary:   Length of Hospital Stay (1st Excision to Discharge (Days))   [ Time Frame: 28 days ]

8.  Secondary:   Number of Patient's With Wound-related Readmissions   [ Time Frame: 28 days and 6 week follow up ]

9.  Secondary:   Number of Patient's With Serious Adverse Events and Relationship to Device   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Robert D Galiano, Assistant Professor of Surgery
Organization: Northwestern Medical Faculty Foundation
phone: 312-695-6022
e-mail: rgaliano@nmh.org


Publications:

Responsible Party: Smith & Nephew Wound Management Inc
ClinicalTrials.gov Identifier: NCT01050673     History of Changes
Other Study ID Numbers: CE/030/VJT
Study First Received: January 13, 2010
Results First Received: June 12, 2012
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board