Prevention of postsurgical wound dehiscence after abdominal surgery with NPWT: a multicentre randomised controlled trial protocol.
OBJECTIVE
The effectiveness of negative pressure wound therapy (NPWT) in the prevention of postoperative surgical wound dehiscence (SWD) is the subject of much debate and remains to be determined. This study will identify individuals at risk of postoperative SWD and trial the use of NPWT as a prophylactic measure against the occurrence of SWD, compared with a non-NPWT standard surgical dressing (SSD).


METHODS
A prospective multicentre randomised controlled trial comparing NPWT dressing against standard surgical dressings (SSD) will be conducted. An intention-to-treat (ITT) approach will be used for the trial.


OBJECTIVE
The primary outcome is the prevention of postoperative SWD up to and including day 30 postoperative. Secondary outcomes are: prevention of surgical site infection (SSI) and economic analysis of treatment groups.


CONCLUSIONS
This study will determine the effectiveness of NPWT in the prevention of postoperative abdominal SWD in a predefined level of risk population. This level 1 study will provide further data for abdominal SWD risk classification, which is anticipated to inform preventive postoperative management. The study design uses a prospective real-world scenario in order to identify clinically significant differences between the intervention and control groups.


BACKGROUND
This trial was prospectively registered on 10 December 2012 with Australian and New Zealand Clinical Trials Network (ANZCTR): 12612001275853.
(PhD Scholar), Research Associate, Adjunct Research Fellow, School of Nursing and Midwifery, Curtin University, Perth, WA, Australia; and School of Anatomy, Physiology and Human Biology, University of Western Australia, Perth, WA, Australia; and Wound Management Innovation Cooperative Research Centre (WMICRC).
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Sandy-Hodgetts
Director of Research, School of Nursing and Midwifery, Curtin University, Perth, WA, Australia; and Wound Management Innovation Cooperative Research Centre (WMICRC).
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Leslie
PhD Senior Lecturer Statistics, School of Occupational Therapy & Social work, Curtin University, WA, Australia; and School of Pharmacy, Curtin University, WA.
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Parsons
Director, Chrysalis Advisory, Adjunct Professor, School of Health Sciences, Curtin University, WA, Australia; and Centre for Comparative Genomics, Murdoch University, Perth, WA, Australia; and School of Pathology and Laboratory Medicine and Colorectal Cancer Research Unit, University of Western Australia, WA, Australia; and School of Medicine, University of Notre Dame Australia.
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Zeps
Professor of Primary Health Care and Community, School of Nursing and Midwifery, Curtin University, Perth, WA, Australia; and Wound Management Innovation Cooperative Research Centre (WMICRC); and Silver Chain Group, WA, Australia.
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Carville
D006801:Humans; D000005:Abdomen / Q000601:surgery; D001458:Bandages; D013505:Digestive System Surgical Procedures / Q000379:methods; D013509:Gynecologic Surgical Procedures / Q000379:methods; D057194:Intention to Treat Analysis; D007813:Laparotomy; D054843:Negative-Pressure Wound Therapy / Q000191:economics / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D013529:Surgical Wound Dehiscence / Q000191:economics / Q000517:prevention & control; D013530:Surgical Wound Infection / Q000191:economics / Q000517:prevention & control; D015337:Multicenter Studies as Topic
economic cost analysis; efficacy; negative pressure wound therapy; randomised controlled trial; surgical wound dehiscence