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Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial)

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4305 (Published 31 July 2013) Cite this as: BMJ 2013;347:f4305

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Re: Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial)

The collaborative efforts at trainee level nationwide need be praised for its significant portent.

But I do have problem with the study!

This trial seems in the end about barrrier method to wound edge infection control and the intervention is about novel mechanical device to prevent or minimise contamination of surgical site.

As in all such methods, the aseptic protocol should span the entire 'skin to skin' interval such that mechanical or barrier protocol is assured from time of incision to skin closure.

My criticism of this study is that there is a window moment in the protocol when the wound edge was exposed to risk; namely removal of the mechanical barrier whilst neither gloves nor contact instruments were changed towards the end of surgery.

No matter how brief that moment, and no matter what a good mechanical barrier the ring had been prior to that moment, its possible efficacy and thus impact became vitiated by the post- device pre-closure wound edge exposure at closure.

Better it might have been, if before removal ofdevice, all used instruments were kept away, gloves changed and new uncontaminated set of instruments used for closure.

As it stands, any Infection rate reported in this trial could have been related not to wound edge contamination whilst the barrier was on, but after it has been removed.

One of. The most vulnerable moments for wound edge is often towards the end of the procedure when everywhere connected with the surgery is at its most sodden and contaminated/colonised.

It will be rash to conclude that this single breach made the trial(and thus conclusion) fatally flawed but I do think it renders the results somewhat less reliable and unfair to the role of barrier methods in surgical site infection control

Competing interests: No competing interests

22 August 2013
basil b basil fadipe
surgeon/ clinical professorsurgery/anatomy
none
justin fadipe centre
mero heights. dominica w/indies