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We congratulate the authors for their innovative efforts in dealing with a clinically relevant issue.1 Indeed this may prove to be a significant breakthrough in the management of difficult enterocutaneous fistulas. However, we were a bit concerned whether an ethical committee approval/informed patient consent was obtained before treatment. This is because Argenta et al considered dehisced wound and fistula a contraindication to a vacuum assisted closure (VAC) system.2 Moreover, continuous suction may hamper closure of fistulas. I would be grateful if the authors could shed light on this aspect.
We are grateful to Mr Saklani and Mr Delicata for their interest in our report. We were aware before using this device that enterocutaneous fistula has been suggested as a possible contraindication to the use of the VAC system. In the first patient on whom we used this system, it had proved impossible to achieve adherence of any wound care product despite the attention of an experienced tissue viability nurse and a stoma therapist. As a result, the patient suffered severe pain from skin excoriation and frequent embarrassment from leakage of intestinal contents. Against this background we discussed with her the option of using the VAC device. She was informed this was traditionally regarded as a contraindication to the use of the device. It seemed unlikely that the use of this device could cause additional problems as a fistula was already established.
As our paper reports the outcome was very satisfactory. Based on this anecdotal experience, we had similar discussion with the subsequent patients.
It is not necessary to obtain ethics committee approval for the use of novel treatments in desperate situations. We would agree, however, that if a prospective study of the VAC device was to be performed ethics committee approval would be mandatory.
Saklani and Delicata have raised interesting questions relating to the introduction of new techniques. Do ethical committees have a role in the treatment of individual patients as opposed to the conduct of a clinical trial where different modalities of treatment are under investigation and comparison? With the emergence of bioethics and medical ethics, it should be the role of ethics committees to concern themselves with such issues. However, their role would then include many other aspects of life and death in which clinical interventions played a part. Are ethics committees prepared to take on this role, and are their members adequately trained to fulfil it?
Patients need advocates who can put their view, and although nurses have traditionally claimed this ground, the patient advocate of the 21st century needs to be an independent practitioner. As to informed patient consent, we need to move towards informed patient choice where patients choose between options based on a comprehensive package of information. Anything less smacks of medical paternalism.