Benefits of new wound therapy questioned

NEW YORK, Aug 9 (Reuters) More and more doctors are using a new high-tech device to treat chronic wounds such as bed sores and diabetic ulcers, but there is little evidence the device is any better than standard therapies, according to a review of studies on the technique.

In fact, the new method -- known as topical negative pressure -- may cause harm in some cases, warn the authors of the report.

''It would be wrong to sort of suggest its very dangerous, that would be unfair, but on the other hand it certainly isn't risk-free,'' Dr. Ike Iheanacho, the editor of Drug and Therapeutics Bulletin, where the review is published, told Reuters Health.

The treatment, also called vacuum-assisted closure or V A C Therapy, involves placing a foam dressing on a wound, which is then attached to a device that exerts suction, drawing out wound fluid.

Makers of the V A C Therapy device recommend that it be used ontinuously for the first 48 hours, and then intermittently thereafter.

The approach may indeed speed healing and help to remove harmful substances such as bacteria from a wound, at least in theory, Iheanacho and his colleagues say. However, the 11 published clinical trials with the therapy have been small and have had major flaws, such as comparing the new treatment to an old-fashioned and labor-intensive therapy such as wet gauze dressing, they add.

Iheanacho's team says one study indicates that the device may speed the healing of post-amputation foot wounds in people with diabetes. While there is evidence that it can also be helpful for people with chronic venous leg ulcers, they add, research that found benefit was done in people who were hospitalized and on bed-rest, which is rarely the case in the real world given the high cost of hospitalization.

''There is no compelling evidence,'' they add, ''that topical negative pressure helps skin graft 'take,' or the healing of pressure ulcers or simple diabetic foot ulcers.'' Adverse effects of the device, Iheanacho noted, could include damage to the wound, and pain. It also can be ''cumbersome'' for patients to be attached to the device for long stretches of time.

According to Iheanacho, V A C Therapy is growing in popularity both in the UK and elsewhere in the world. He suggested that the device has a certain high-tech appeal, and that the plausibility of its proposed effects is also attractive. ''There's a kind of glamour I suppose about using it -- there often is with new treatments.'' Nevertheless, he and his colleagues conclude, there is too little evidence to justify the use of the device ''outside a research setting.'' Requests to the manufacturer of the V A C Therapy device for comments on the review were not answered.

Iheanacho's advise to anyone who is offered topical negative pressure wound treatment is to ask why it's being recommended, what the health professional's experience is with the therapy, and whether there are any alternatives. ''Certainly patients should not assume that just because someone's offering this technique to them that it must be the best available,'' he said.

Reuters CS DB0910