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Randomised controlled trial of pressure Irrigation of major surgical wounds

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000170820
Enrollment
128
Registered
2012-02-07
Start date
2010-08-11
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 (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 deliv

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.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Emergency surgery Surgical time less than 2 hours

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 10, 2026