Trial Outcomes & Findings for Trial of Versajet Compared With Conventional Treatment in Acute and Chronic Wounds (NCT NCT01050673)

NCT ID: NCT01050673

Last Updated: 2018-03-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 28 days plus 6 week follow-up
• Results posted on: 2018-03-12

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	21	19
Overall Study COMPLETED	17	14
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Measure	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.
Overall Study Physician Decision	4	5

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	VERSAJET n=21 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 Participants 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 n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	52.2 years STANDARD_DEVIATION 15.5 • n=5 Participants	57.1 years STANDARD_DEVIATION 13.7 • n=7 Participants	54.5 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	19 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days plus 6 week follow-up

Outcome measures

Measure	VERSAJET n=21 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 Participants 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.
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	15 Time (minutes) Standard Deviation 8.5

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	VERSAJET n=21 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 Participants 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.
Time of Actual Excision Procedure	7 Time (Minutes) Standard Deviation 3.7	15 Time (Minutes) Standard Deviation 8.5

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	VERSAJET n=21 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 Participants 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.
Cost Per Operative Procedure	4411.70 Dollars $ Standard Deviation 2020.2	6014.10 Dollars $ Standard Deviation 4143.3

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	VERSAJET n=21 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 Participants 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.
Cost of Reference Wound-related Surgical Procedures to Achieve Closure	13689.1 Dollars ($) Standard Deviation 8154.3	12869.4 Dollars ($) Standard Deviation 5703.3

SECONDARY outcome

Timeframe: 28 days

Population: Pre and post-excision values added, (cfu/g) tissue.

Outcome measures

Measure	VERSAJET n=20 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 Participants 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.
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	4.0 cfu/g Standard Deviation 1.5
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 2.0	3.3 cfu/g Standard Deviation 1.6

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	VERSAJET n=21 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 Participants 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.
Percentage of Patients Achieving Stable Closure Within Study Period	42.9 percentage of patients	42.1 percentage of patients

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	VERSAJET n=21 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=17 Participants 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.
Length of Hospital Stay (1st Excision to Discharge (Days))	39 Days Standard Deviation 22.6	38 Days Standard Deviation 18.7

SECONDARY outcome

Timeframe: 28 days and 6 week follow up

Outcome measures

Measure	VERSAJET n=21 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 Participants 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.
Number of Patient's With Wound-related Readmissions	1 Number of patients	0 Number of patients

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Measure	VERSAJET n=21 Participants Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 Participants 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.
Number of Patient's With Serious Adverse Events and Relationship to Device	5 Number of patients	5 Number of patients

Adverse Events

VERSAJET

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Therapy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	VERSAJET n=21 participants at risk Excision with VERSAJET™ Hydrosurgery System	Conventional Therapy n=19 participants at risk 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.
Infections and infestations calcaneal pin site infection leading to foot gangrene	4.8% 1/21 • Number of events 1	0.00% 0/19
Skin and subcutaneous tissue disorders sacral pressure sore	4.8% 1/21 • Number of events 1	0.00% 0/19
Metabolism and nutrition disorders urinary tract infection	4.8% 1/21 • Number of events 1	0.00% 0/19
Skin and subcutaneous tissue disorders flap dehiscence	4.8% 1/21 • Number of events 1	0.00% 0/19
Gastrointestinal disorders small bowel obstruction	4.8% 1/21 • Number of events 1	0.00% 0/19
Skin and subcutaneous tissue disorders flap failure	0.00% 0/21	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders seroma leading to limited flap dehiscence	0.00% 0/21	5.3% 1/19 • Number of events 1
Infections and infestations infection leading to prolonged hospitalisation and an amputation of the distal portion of the right	0.00% 0/21	5.3% 1/19 • Number of events 1
Skin and subcutaneous tissue disorders partial flap failure/dehiscence	0.00% 0/21	5.3% 1/19 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr Robert D Galiano, Assistant Professor of Surgery

Northwestern Medical Faculty Foundation

Phone: 312-695-6022

Email: rgaliano@nmh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place