Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000170820
Ethics application status
Approved
Date submitted
3/02/2012
Date registered
7/02/2012
Date last updated
7/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of pressure Irrigation of major surgical wounds
Scientific title
Randomised controlled trial of pressure irrigation of major surgical wounds to reduce wound infections
Secondary ID [1] 279873 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound infections after major elective abdominal surgery 285777 0
Condition category
Condition code
Surgery 285953 285953 0 0
Other surgery
Infection 285968 285968 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 285969 285969 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284196 0
Treatment: Devices
Intervention code [2] 284213 0
Prevention
Comparator / control treatment
In the control group 2 litres of sterile saline solution is poured slowly into the wound pior to skin closure.
Control group
Active

Outcomes
Primary outcome [1] 286437 0
The primary outcome measure in this study is the rate of wound infection. Wounds will be assessed at one week following surgery and again two weeks thereafter, unless otherwise indicated. Wound infections is defined based on the following criteria:


Superficial Surgical Site infection (SSI)
Occurs within 30 days after the operation and infection involves only skin or subcutaneous tissue of the incision and at least
one of the following:
1. Purulent drainage, with or without laboratory confirmation, from the superficial incision.
2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.
3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial
incision is deliberately opened by surgeon, unless incision is culture-negative.
4. Diagnosis of superficial incisional SSI by the surgeon or attending physician.
Do not report the following conditions as SSI:
1. Stitch abscess (minimal inflammation and discharge confined to the points of suture penetration).
2. Infection of an episiotomy or newborn circumcision site.
3. Infected burn wound.
4. Incisional SSI that extends into the fascial and muscle layers (see deep incisional SSI).

Deep incision Surgical site infection
Infection occurs within 30 days after the operation if no implant? is left in place or within 1 year if implant is in place and the infection
appears to be related to the operation and infection involves deep soft tissues (e.g., fascial and muscle layers) of the incision and at
least one of the following:
1. Purulent drainage from the deep incision but not from the organ/space component of the surgical site.
2. A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following
signs or symptoms: fever (>38 degrees Celsius), localized pain, or tenderness, unless site is culture-negative.
3. An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by
histopathologic or radiologic examination.
4. Diagnosis of a deep incisional SSI by a surgeon or attending physician.
Timepoint [1] 286437 0
Wound infection rates within one month of surgery is assessed
Secondary outcome [1] 295893 0
Factors contributing to wound infections are analysed.
Univariate and multivariate analysis will be undertaken assessing the relationship of various pre-operative (eg. patient age, gender, medical comorbidites etc...), intra-operative (type of surgery, duration, fluids administered etc..) and post operative factors (duration of antibiotics, presence of drain tubes, need for blood transfusions etc...) on the development of wound infections.
Timepoint [1] 295893 0
Within one month of surgery

Eligibility
Key inclusion criteria
Adult patients (age > 18years) undergoing elective major abdominal surgery that extend beyond 2 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency surgery
Surgical time less than 2 hours

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each patient electively booked for major abdominal surgery within a specialized hepatobiliary pancreatic unit will be considered to be potentially suitable for this trial. Patient will be informed that they are being asked to participate in a wound management trial and that all will have their wounds treated by washout at the end of the case, either by pulse irrigation or standard washout. All patients must be able to consent for surgery and the study. Patients will be randomized only if the operative procedure at the time of skin closure has extended to 2 hours or beyond.

Control and Pulse irrigation groups tags will be placed in a large envelope. Diabetic patients are randomised seperately to ensure even distribution in each group. At the time of skin closure, a grouping tag is blindly drawn from an envelope according to whether the patient is known to be diabetic or not. At this point they are assigned to either control or pulse irrigation treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation) will be preformed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284641 0
University
Name [1] 284641 0
University of Melbourne
Country [1] 284641 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University Department of Surgery
Austin Hospital
Studley Rd, Heidelberg, VICTORIA 3084
Country
Australia
Secondary sponsor category [1] 283554 0
None
Name [1] 283554 0
Address [1] 283554 0
Country [1] 283554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286634 0
Austin Health Reseach Ethics unit
Ethics committee address [1] 286634 0
Austin Health Research Ethics Unit
Henry Buck Building
Austin Hospital
Studley Road
Heidelberg, Victoria
3084
Ethics committee country [1] 286634 0
Australia
Date submitted for ethics approval [1] 286634 0
Approval date [1] 286634 0
11/08/2010
Ethics approval number [1] 286634 0
03909

Summary
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.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33733 0
Address 33733 0
Country 33733 0
Phone 33733 0
Fax 33733 0
Email 33733 0
Contact person for public queries
Name 16980 0
Dr Mehrdad Nikfarjam
Address 16980 0
University department of Surgery
Austin Health
Studley Road
Heidelberg, Victoria, 3084
Country 16980 0
Australia
Phone 16980 0
+61 3 9496 5000
Fax 16980 0
+61 3 9458 1650
Email 16980 0
[email protected]
Contact person for scientific queries
Name 7908 0
Dr Mehrdad Nikfarjam
Address 7908 0
University department of Surgery
Austin Health
Studley Road
Heidelberg, Victoria, 3084
Country 7908 0
Australia
Phone 7908 0
+61 3 9496 5000
Fax 7908 0
+61 3 9458 1650
Email 7908 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23212Other    362055-(Uploaded-28-07-2020-16-48-31)-Study-related document.pdf
23821Other    Paper Published World Journal of Surgery

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.