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International Journal of Colorectal Disease

, Volume 34, Issue 11, pp 2003–2010 | Cite as

Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial

  • Noel Edward DonlonEmail author
  • P. A. Boland
  • M. E. Kelly
  • K. Schmidt
  • F. Cooke
  • P. M. Neary
  • K. M. Barry
  • J. V. Reynolds
CLINICAL STUDY PROTOCOL
  • 129 Downloads

Abstract

Background

Superficial surgical site infections are a common post-operative complication. They also place a considerable financial burden on healthcare. The use of prophylactic negative pressure wound therapy has been advocated to reduce wound infection rates. However, there is debate around its routine use. The purpose of this trial is to determine if prophylactic negative pressure wound therapy reduces post-operative wound complications in patients undergoing laparotomy.

Methods/design

This multi-centre randomised controlled trial will compare standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™). All patients will be over 18 years, who are undergoing an emergency or elective laparotomy. It is intended to enrol a total of 271 patients for the trial.

Discussion

The PROPEL trial is a multi-centre randomised controlled trial of patients undergoing laparotomy. The comparison of standard treatment to two commercially available NPWT will help provide consensus on the routine management of laparotomy wounds.

Trial registration

This study is registered with ClinicalTrials.gov (NCT number NCT03871023).

Keywords

Emergency surgery Surgical site infection Wound management Negative pressure wound therapy 

Notes

Compliance with ethical standards

The protocol has been approved by the ethics committee at Tallaght University Hospital/St. James Hospital Dublin and consent was obtained from other participating centres.

Conflict of interest

The authors declare that they have no conflict of interest.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of SurgerySt James HospitalDublin 8Ireland
  2. 2.Department of SurgeryWexford General HospitalWexfordIreland
  3. 3.Department of SurgeryUniversity Hospital WaterfordWaterfordIreland
  4. 4.Department of SurgeryMayo University HospitalMayoIreland

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