EVALUATION OF NEGATIVE-PRESSURE WOUND THERAPY

Transcription

1 EVALUATION OF NEGATIVE-PRESSURE WOUND THERAPY JANUARY 2010 Medical Devices Assessment Department 1

2 You can download this document on the following web site Haute Autorité de santé Service communication 2, avenue du Stade de France F Saint-Denis La Plaine CEDEX Tél. : + 33 (0) Fax : + 33 (0) Haute Autorité de santé

3 THE TEAM This dossier was compiled by Michel Vaneau, project manager and Doctor of Pharmacy at the Medical Devices Assessment Department, tel: +33 (0) , Document research was carried out by Gaëlle Fanelli and Virginie Henry, researchers, and Yasmine Lombry, assistant researcher. Meetings were arranged and secretarial work was undertaken by Stephanie Luzio (tel: +33 (0) Fax: +33 (0) , e-mai l: Head of Medical Devices Assessment Department: Catherine Denis, MD (tel: : +33 (0) , c.denis@has-sante.fr). Assistant head of department: Hubert Galmiche. Head of Documentation & Public Information Department: Frédérique Pagès. 3

4 WORKING GROUP The working group consisted of the following professionals: - Dr Jean-Christophe Bel - Orthopedic Surgeon - Lyon - Professor Dominique Casanova - Plastic Surgeon - Marseille - Dr Guillaume Chaby - Dermatologist - Amiens - Professor Olivier Chapuis - Thoracic surgeon - Clamart - Dr Xavier Flecher - Orthopedic Surgeon - Marseille - Maryse Guillaume - Registered nurse - Castres - Dr François Guillon - Visceral surgeon - Montpellier - Professor Bernard Guillot - Dermatologist - Montpellier - Dr Jean-Claude Guimberteau - Plastic Surgeon - Pessac - Professor Agnes Hartemann-Heurtier - Diabetologist - Paris - Dr Didier Ollat - Orthopedic Surgeon - Paris - Professor Vincent Pinsolle - Plastic Surgeon - Bordeaux - Dr Patricia Senet - Dermatologist - Ivry-sur-Seine The working group was formed at the proposal of the learned societies concerned. In accordance with decree No of 26 October 2004 (article R to R of the Social Security Code), all members of the group completed a public declaration of interests to inform HAS of any conflicts of interest that might exist between certain members of the group and a manufacturer. Under the criteria laid down in the HAS guide, Guide des déclarations d intérêts et de prévention des conflits [Guide to declaration of interests and prevention of conflicts of interest], none of the members of the working group are considered to have a conflict of interest. The opinion of the working group was confirmed by 12 of its members. 4

5 SUMMARY Context Negative-pressure wound therapy (NPWT) consists in placing the surface of a wound under a pressure that is below ambient atmospheric pressure. This is done by connecting a specially designed dressing to a negative-pressure source and an exudate collection system. Integrated NPWT systems have been around for nearly twenty years. They are available as a substitute for the dressings usually used to treat acute or chronic wounds for limited periods in particular situations. Those situations mainly involve unsuturable wounds and wounds where healing by first intention fails. Use of NPWT is growing in hospital settings and is funded by hospitals through Diagnosis related Groups. There are both strictly hospital applications and uses as part of home hospitalisation. In view of the implications for hospitals of the emergence of several competing NPWT systems and with users expecting good practice recommendations, the Haute Autorité de Santé decided to set about evaluating negative-pressure wound treatment. Working method The evaluation is based on the following sources of information: a systematic review of the literature, a search for original data from manufacturers and distributors in France, an analysis of dossiers submitted by manufacturers, the expertise of healthcare professionals meeting in a multidisciplinary working group on the subject. Evaluation Critical analysis of the data The literature search covering the period from January 2000 to April 2009 resulted in the analysis of 14 literature reviews produced by independent bodies (literature reviews, whether or not used in a technological evaluation study or in preparing recommendations) and 13 randomised controlled studies that met the selection criteria. Among the literature reviews, the publications that appeared between 2003 and 2008 reveal the poor quality and the limited nature of the clinical studies published; they recommend the initiation of rigorously designed studies. Nevertheless, a number of these reviews and technological evaluations favour the use of NPWT for specially selected patients in view of its potential therapeutic value. The updated bibliographical data produced during this study do not identify any clinical studies likely to alter the conclusions of the reviews already published. The clinical studies used all have a low level of evidence. They do not demonstrate the value of the technique as compared to the alternatives, nor do they provide a means of comparing the different NPWT techniques with one another. Overall, there is no formal scientific proof of the value of NPWT. 5

6 Working group opinion The clinical experience of group members was used to identify a limited number of situations encountered in specialist units for which NPWT is of value. In all cases, and taking account of the adverse effects and drawbacks inherent in the technique, the decision to use NPWT must be taken only after considering and weighing up the use of conventional treatments. NPWT is an adjuvant wound healing treatment. It has specific adverse effects, contraindications, precautions for use and drawbacks. It must not be an easy solution for the caregiver. In addition, any NPWT treatment must be initiated for a limited period and be accompanied by strict monitoring of the wound s progress. In clinical situations where the use of NPWT might be justified, a clear objective in terms of the wound s progress must be specified at the start of treatment. If there is no improvement between two changes of dressing or in one week, treatment must be stopped. The working group, on the basis of its clinical experience (expert opinion), unanimously proposed restricting the use of NPWT to the following clinical situations: Acute conditions traumatic, unsuturable wound, with extensive and/or deep loss of substance, with or without infection, surgical excision with extensive and/or deep loss of substance, with or without infection, dehiscence of a surgical wound, extensive or in an unfavourable location, with or without superinfection, trimmed first if necessary, laparostomy. Chronic conditions (as second line therapy) leg ulcers requiring a skin graft, stage 3 or 4 pressure sore, to achieve surgical closure, diabetic foot wound with extensive and/or deep loss of substance. In addition, the group advocates the following conditions of use: NPWT must be used until granulation tissue is produced or the condition is amenable to surgical treatment; NPWT must be initiated in a healthcare establishment (medicosurgical, rehabilitation or geriatric centre) by a medical specialist (plastic surgeon, abdominal surgeon, vascular surgeon, thoracic surgeon, orthopaedic surgeon, diabetologist or dermatologist); monitoring is done by the initial prescriber; treatment should be stopped if there is no improvement after 2 consecutive dressing changes or one week of use; the maximum duration of treatment is 30 days (can be repeated once if necessary); specific training in the technique is needed by all caregivers; the patient must be informed of the adverse effects of NPWT and the constraints associated with its use; treatment can be given as part of hospitalisation at home, subject to weekly assessment by the initial prescriber. 6

7 Conclusion HAS opinion Since there are no clinical studies with a good level of evidence, this evaluation by the Haute Autorité de Santé (HAS) is based mainly on the expertise of a multidisciplinary working group made up of healthcare professionals. It takes account of the potential value of the technique in certain carefully selected patients. HAS has accepted limited-period uses targeting precisely defined clinical situations for certain chronic wounds (use as second-line therapy) or acute wounds (possible use as first-line therapy). The decision to use NPWT must be taken only after simpler conventional treatments have been considered or actually tried. In addition, a clear objective in terms of wound progress must be set when NPWT is started, accompanied by strict monitoring of that progress. If there is no improvement between two consecutive changes of dressing or after one week of use, the treatment must be stopped. NPWT must satisfy precise conditions of use. Specific training is required for all caregivers, plus information for the patient about the objective of the treatment, its adverse effects and its constraints. It must be prescribed following an opinion given by a specialist (plastic surgeon, dermatologist, diabetologist, etc.) and started in a healthcare establishment (it can then be continued in hospitalisation at home, with weekly assessment by the initial prescriber). The maximum prescribed period is 30 days, repeatable just once by the initial prescriber. There are no clinical grounds for distinguishing between the different medical devices currently available on the market. Finally, set-ups using the hospital s central vacuum system (and not a specific integrated device) raise questions about the safety of their use and the reliability of the underpressure obtained. Although the opinions expressed by the experts were divided, HAS cannot recommend use of these techniques. 7