Evidence review | The Versajet II hydrosurgery system for surgical debridement of acute and chronic wounds and burns | Advice

Clinical and technical evidence

There was no evidence found through independent searches or provided by the manufacturer about the clinical effectiveness or safety of the Versajet II system. Two pre-clinical studies in the form of conference posters were available. One evaluated the speed of set up of the Versajet II system compared with the original Versajet system (Liebert 2011) and concluded that the Versajet II system was faster by a number of seconds. The other evaluated pig subcutaneous tissue depth removed at 45° and 90° angles and at various power settings for both models (Martin 2012). This found that the Versajet II system removed tissue more deeply than the Versajet system at the same power settings, within 1 standard deviation of the depth.

It is assumed that the clinical evidence for the Versajet system would also apply to the Versajet II system, because the manufacturer's website cites references to studies on the Versajet system rather than any new studies on the Versajet II system. Therefore, the evidence for the Versajet system has been summarised here.

There were 6 randomised controlled trials evaluating the Versajet system found: Anniboletti 2011 (abstract), Caputo 2008, Esposito 2009 (abstract), Gravante 2007, Lantis (2013) (abstract) and Liu 2012 (abstract). Three were on burns (see table 1) and 3 were on chronic wounds (see table 2). There were 4 non-randomised comparative studies found: Granick 2006, Mosti 2006 and Scholten 2011 (abstract). Mosti 2005 was a subset of Mosti 2006 so is not described here. See table 3 for the details and results of the comparative studies. Critical appraisal of the conference abstracts was limited as there was insufficient information on study conduct and the results that were presented. All relevant numerical results are included in the tables. The abstracts were not peer reviewed, so their results may not be as accurate as the fully published studies. However, they have been included because they do present interesting findings on the Versajet system.

Many of the studies did not give numerical results per group, just statistical comparisons (p values), so meta-analysis was not done.

The outcomes suggested mixed results. Compared with the study comparators (see tables 1, 2 and 3):

There was no difference in time to debride (3 randomised controlled trials, 1 comparative study) or the Versajet system was faster (2 randomised controlled trials, 1 comparative study).
Healing time or wound closure was no different (3 randomised controlled trials, 1 comparative study) or shorter with the Versajet system compared with sharp debridement with scalpel plus pulse lavage (1 randomised controlled trial).
Contractures were no different compared with hand held dermatome escharectomy (1 randomised controlled trial). The mean number of surgical procedures was lower in the Versajet arm (1 comparative study).
Bacterial load was no different with the Versajet system compared with conventional debridement with scalpels and electrocautery (1 randomised controlled trial) or worse after using the Versajet system compared with sharp debridement (1 randomised controlled trial).
There was no difference in hypertrophy compared with conservative treatment or guarded knife (1 comparative study).
Pain experience was no different (1 randomised controlled trial, 1 comparative study).
There was less blood loss using the Versajet system compared with conventional debridement with scalpels and electrocautery (1 randomised controlled trial) but in another randomised controlled trial a large blood vessel was cut in the Versajet system group.

In one randomised controlled trial, 25% of patients had adverse events in the Versajet arm compared with 9.5% in the comparator arm. In one comparative study there were 2 patients with new necroses along the wound margins after treatment with the Versajet system.

Table 1. Summary of randomised controlled trials on the Versajet system for patients with burns

Study component	Description
	Anniboletti 2011 (abstract)	Esposito 2009 (abstract)	Gravante 2007
Objective/ hypothesis	Report experience with Versajet	Report experience with Versajet	Compare Versajet to escharectomy
Setting (country)	Unclear (Italy)	Unclear (Italy)	Burn centre in hospital (Italy)
Participants	Total n=35 including 12 children 17 Versajet, 18 escharectomy Age/sex/wound characteristics not given	Total n=36 including 8 children. 14 Versajet, 12 escharectomy, Age/sex/wound characteristics not given	Total n=100 of which 87 received allocated treatment 42 Versajet (17 women, mean age 46 (SD=27), 19 with deep burns), 45 escharectomy (20 women, mean age 50 (SD=28), 21 with deep burns)
Comparator	Hand held dermatome escharectomy	Hand held dermatome escharectomy	Hand held dermatome escharectomy
Variables	Time to debride, correct dermal plane, wound healing, pain, adverse events	Speed of debridement	Operative time, post-operative pain, complete healing, contractures at 6 months
Statistical methods	Unclear	Unclear	Student's T Test
Main numerical results	No difference in time to debridement (p=0.4). Healing time shorter (by 7 days on average) (Pain results not given)	No difference in speed of debridement (p=0.4)	Operative time similar overall (less for limbs or trunk, more for hands, genitals, face). Complete healing in days: Versajet 11 (SD=2), escharectomy 13 (SD=2) (p=NS) Post-operative pain (mean (SD)) Versajet 4.3 (1.6), escharectomy 4.6 (1.2) (p=NS) Contractures at 6 months Versajet n=14, escharectomy n=16 (p=NS)
Safety, adverse events	Not given	Not given	1 patient – larger blood vessel cut in Versajet group.
Narrative results/ conclusions from the article	'Benefits in the treatment of deep burns' 'More easy to reach desirable plane'	'Easier to reach the desirable plane'	'Versajet is a feasible, simple and safe technique'
Quality	Conference abstract so very little information on study conduct	Conference abstract so very little information on study conduct	No information on randomisation, allocation concealment or blinding of outcome assessment
Conclusions	Conference abstract so results should be treated with caution	Conference abstract so results should be treated with caution	Due to the conduct of the study, results may not be reliable
p, probability; SD, standard deviation; N, number; NS, not statistically significant.

Table 2. Summary of randomised controlled trials on the Versajet system for patients with chronic wounds

Study component	Description
	Caputo 2008	Lantis 2013 (abstract)	Liu 2012 (abstract)
Objective/ hypothesis	Measure debridement time with Versajet vs comparator	Compare bioburden before and after Versajet or sharp debridement	Report clinical and cost effectiveness of Versajet
Setting (country)	Medical centre (USA)	Unclear (USA)	Unclear (USA)
Participants	Lower extremity ulcers Total n=41 19 Versajet (4 women, mean age 68.5, median wound duration 1.2 months) 22 comparator (11 women, mean age 67.6, median wound duration 1.2 months)	Chronic lower leg wounds Total n=14. (numbers in each group not given) Age/sex not given, mean wound duration 13.9 months vs 18.8 months	Chronic wounds Total n=40 21 Versajet, 19 comparator Age/sex/wound characteristics not given
Comparator	Sharp debridement with scalpel plus pulse lavage	Sharp debridement	Conventional debridement with scalpels and electrocautery
Variables	Debridement time, wound closure, adverse events	Bacterial load after debridement	Time to wound closure, bacterial count, first excision time, total excision time, blood loss
Statistical methods	Wilcoxon Rank Sum, Kaplan Maier, Multiple regression,	Unclear	Unclear
Numerical results	Debridement with Versajet significantly quicker (p=0.008). No difference in wound closure time (median 71 days Versajet, 74 days comparator, p=0.73).	Bacterial load – 75% bacteria killed by hydrosurgery compared with 93% killed by sharp debridement (p<0.05)	Versajet – significant improvement for first excision time (p<0.001) and total excision time (p=0.005) No difference in time to wound closure (p=0.77) No difference in bacterial count (p=0.38) Less blood loss (p=0.003) (NB only p values given)
Safety, adverse events	Serious adverse events – 25% patients Versajet, 9.5% comparator (no p value given)	Not given	Not given
Narrative results/ conclusions from the article	'Quicker without compromising wound healing'	'sharp debridement superior for bacterial elimination'	'System did offer advantages'
Quality	Randomisation method not given, treatment allocation revealed 2 days before treatment. Outcome assessment not blinded.	Conference abstract so very little information on study conduct	Conference abstract so very little information on study conduct
Conclusions	Due to the conduct of the study, results may not be reliable	Conference abstract so results should be treated with caution	Conference abstract so results should be treated with caution
p, probability.

Table 3. Summary of the non-randomised comparative studies on the Versajet system

Study component	Description
	Granick 2006	Mosti 2006	Scholten 2011 (abstract)
Objective/ hypothesis	Evaluate efficacy, safety and economic impact of Versajet	Report experience with Versajet	Report scar quality with Versajet compared with comparators
Setting (country)	Hospital plastic surgery unit (USA)	Hospital (Italy)	Burn centre in hospital (Netherlands)
Participants	Acute and chronic wounds. n=62 Versajet – 40 (45 wounds) 22 women, mean age 46, 49% chronic wounds comparator – 22 patients (22 wounds) (10 women, mean age 53, 64% chronic wounds)	Chronic leg ulcers, n=469 Versajet – 142, (95 women, mean age 71.3, mean wound duration 55 months) comparator – 327 (222 women, mean age 70.8, mean wound duration 35.9 months)	Burns. Total n=114 (number in each group not given) Age/sex/wound characteristics not given
Comparator	Sharp debridement	Moist dressings (hydrogel, hydrocolloid)	A, conservative B, guarded knife
Variables	Time to debridement, number of surgical procedures, safety, costs	Pain (VAS), healing rate, and time to obtain clean wound bed, patient satisfaction.	Scar assessment, hypertrophy
Statistical methods	Regression model	None	Unclear
Numerical results	No difference in debridement time (p=0.159) Mean number of surgical procedures less (Versajet 1.18, comparator 1.91 (p=0.002))	Mean time to obtain clean wound bed Versajet 1.3 (SD 0.6), comparator 4.3 (SD 3.9) Healing rate Versajet 82%, comparator 88% Pain (VAS) Versajet 4.3 (SD 1.9), comparator 5.3 (SD 2.1) Patient satisfaction 2.8 (SD 0.1) in both groups	No difference in hypertrophy, (overall results for scar scores not given)
Safety, adverse events	Not given	New necroses after Versajet treatment in 2 patients.	Not given
Narrative results/ Conclusions from the article	'no difference in debridement time'	'reduces the bacterial burden in the wound'	'better result in scar quality' with hydrosurgery
Quality	Historical controls treated by the same surgeon in the previous year. No blinding of outcome assessment.	Unclear as to how patients were chosen for Versajet treatment. No blinding of outcome assessment.	Conference abstract so very little information on study conduct
Conclusion	Due to the conduct of the study, results may not be reliable	Due to the conduct of the study, results may not be reliable	Conference abstract so results should be treated with caution
p, probability; VAS, visual analogue scale; SD, standard deviation; N, number.

Costs and resource consequences

In a small retrospective cost study with historical controls investigating 45 patients treated in the USA in 2002–3 it was estimated that the average number of debridement procedures to achieve a healthy wound was 1.2 for the Versajet system and 1.9 for conventional surgical debridement (Granick 2006). In this study the cost of debridement per patient was estimated at $6229 for conventional debridement and $4507 for the Versajet system. These estimates should be treated with considerable caution as there are a number of unexplained issues: the mean cost of the debridement procedure was estimated to be the same for both types of procedure, there were more costs of diagnostic tests and pathology in the conventional procedure arm, and there were no allowances for training in the use of the Versajet system. The increased cost estimates for the operating room and recovery room resource use was more than expected compared with the mean number of debridement procedures in the 2 groups.

A small randomised controlled trial of the Versajet system debridement compared with conventional debridement in the USA in 40 patients (Liu 2012) found no significant difference between the 2 groups in terms of cost of the first operative procedure, cost of surgical procedures during the study, cost of study treatment or cost to achieve stable wound closure.

The Versajet system is being used in the NHS. The manufacturer estimated that 105 centres are currently using the Versajet system on a routine basis (including all of the major burns centres) and a further 20–30 centres are using it less frequently. The majority of use is in burns, and vascular, orthopaedic and podiatry procedures. There is some limited adoption in community settings. No NHS sales information was available.

With regard to future resource consequences of adopting the Versajet II system:

Other than the need to schedule cases efficiently when and where the device is available for use, there are no anticipated changes to the way current services are organised or delivered.
There are no additional facilities or technologies needed alongside the Versajet system.
Staff members need to be trained properly in the use of the Versajet II system because if it is used incorrectly at high settings it can damage viable tissue. It is also possible that bacteria on the wound could be converted into an aerosol that could spread infection.

Strengths and limitations of the evidence

A strength of the evidence is that 6 randomised controlled trials and 3 non-randomised comparative studies were found. Specific features in quality are listed in tables 1–3 (above) and are addressed below. Four of the randomised controlled trials were available in abstract form only, so the quality of these studies cannot be assessed because of lack of information; as a general caution, results from conference abstracts do not always correlate well with the final published results in peer-reviewed articles.

The quality of the 2 fully published randomised controlled trials was poor (randomisation method was not given, treatment allocation was inadequate, outcome assessment was not blinded). Studies like these are unlikely to give unbiased estimates of treatment effects. Also, conclusions drawn from them are unlikely to be useful because they are potentially misleading. There were no sample size calculations given so it was unclear whether the samples were large enough to detect differences in outcomes, even if the quality of the studies had been adequate. Non-randomised comparative studies are even more prone to biases than randomised studies so their results may not be as accurate. However, they had relatively large samples compared with the randomised controlled trials, which is why they were included in the evidence review. Where historical controls were used it was unclear if other aspects of treatment might have changed.