RecruitingACTRN12612000170820

Randomised controlled trial of pressure Irrigation of major surgical wounds

Randomised controlled trial of pressure irrigation of major surgical wounds to reduce wound infections


Sponsor

University of Melbourne

Enrollment

128 participants

Start Date

Aug 11, 2010

Study Type

Interventional

Conditions

Summary

Wound infections after major surgery on the abdomen are very common. About 20-30 % of patients undergoing major prolonged abdominal surgery experience some form of wound infection. Although most of these infections are minor and often able to be treated by a short period of antibiotics or by release of the infection from the wound by drainage, in some cases it can be very serious resulting in the need for further surgical treatment or prolonged medical and nursing care. Although there have been improvements in surgical techniques to reduce wound infections, there is still room for improvement, in particular after prolonged operations. The purpose of this project is to see if we can reduce the rate of wound infections, by irrigating wounds at the end of procedures using a wound irrigating device with 2 litres of saline. This has been shown to reduce wound infections after major orthopaedic operations, but has not been well tested for major abdominal wounds. Participants will be assigned to having their wounds irrigated with either a pulse irrigator device or having standard treatment of saline poured into the wounds. GROUP 1. (n=64) Pulsed Irrigation Group The Surgilav (Stryker (Registered Trademark) pulse irrigating device (psi <15) is used in this group for wound irrigation. Wounds are wound irrigated with 2 litres of sterile saline solution delivered by the pulse irrigator prior to a routine closure methods. GROUP 2 (n=64) Standard Irrigation Group Patients assigned to this group will have their wounds irrigated with sterile saline solution, poured slowly into the wound, with excess fluid removed at the end of the procedure with a pad in the usual manner. The skin is closed in the usual fashion. Recruiting Hospitals: Austin Health & Warringal Private Hospitals Clinical significance: Significant reductions in wound infections in patients undergoing prolonged major abdominal operations will have a major impact in improving overall outcomes and reducing costs both to patients and hospital.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Adult patients (age > 18years) undergoing elective major abdominal surgery that extend beyond 2 hours.

Exclusion Criteria2

  • Emergency surgery
  • Surgical time less than 2 hours

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Interventions

The use of wound irrigation in the setting of major prolonged (operations extending beyond 2 hours duration) intra-abdominal procedure has not been tested in a randomised fashion. The Surgilav (

The use of wound irrigation in the setting of major prolonged (operations extending beyond 2 hours duration) intra-abdominal procedure has not been tested in a randomised fashion. The Surgilav (Stryker (Reistered Trademark) pulse irrigating device (psi <15) is used to irrigate abdominal wounds with 2 litres of sterile saline solution prior to a routine skin closure. Randomisation to the use of the Surgilav device occurs immediately prior to skin closure and the device is used purely to deliver saline into the wounds at a set pressure.


Locations(1)

Australia

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ACTRN12612000170820