Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001492741p
Ethics application status
Not yet submitted
Date submitted
28/01/2022
Date registered
29/11/2022
Date last updated
29/11/2022
Date data sharing statement initially provided
29/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of bacterial binding dressings following colorectal surgery on surgical wound complications in an adult population.
Scientific title
Single blinded randomised control trial evaluating dialkylcarbamoylchloride (DACC) impregnated dRessings for the prevention of Surgical siTe infection in at risk patients uNdergoing Abdominal surgery: the CRISTINA trial.
Secondary ID [1] 306298 0
None
Universal Trial Number (UTN)
U1111-1273-6794
Trial acronym
CRISTINA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal surgery 325055 0
wound healing 325056 0
Condition category
Condition code
Skin 322491 322491 0 0
Other skin conditions
Infection 322492 322492 0 0
Studies of infection and infectious agents
Cancer 322998 322998 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 322999 322999 0 0
Bowel - Small bowel (duodenum and ileum)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial participants will be allocated to either the intervention or control group. There is currently only one DACC dressing (Leukomed Sorbact) available in the wound care dressing. The intervention group will receive the DACC containing dressings following surgery (Leukokmed Sorbact). The DACC dressing is a cover dressing applied over the incision site The control group will receive a dressing that does not contain DACC and has the same dressing properties without the interventional dressing characteristics. Participants allocated to the control group will receive a non DACC dressing. The wear time for both groups will be 14 days, unless otherwise clinical indicated for a dressing change and assessment by the lead PI. Dressing application and wear time is to be conducted according to the manufacturer specifications. Dressings will be applied as per standard of post operative care. Dressings will be visually checked daily by the study lead wound care clinician.
Intervention code [1] 322725 0
Prevention
Comparator / control treatment
Postoperative wound care protocol will be applied in both intervention and control groups. The control group will receive a post operative dressing of equivalence material properties that does not contain DACC.
Control group
Active

Outcomes
Primary outcome [1] 330275 0
The primary outcome will be determined by clinical assessment and diagnosis as well as patient reported outcome. Post discharge surveillance using telemedicine and a phone call at 3o days will be conducted on all trial participants. The primary outcome measurement is defined as the occurrence of surgical site infection as per Centres of Disease Control definition and coding ICD-11 T81.49.
Timepoint [1] 330275 0
Day 30 postoperative
Primary outcome [2] 330276 0
The primary outcome measurement is defined as the occurrence of surgical wound dehiscence as defined by World Union of Wound Healing Societies definition and coding ICD 11: T81.3. Post discharge surveillance will be conducted using telemedicine and a phone call at 30 days after surgery.
Timepoint [2] 330276 0
Day 30 postoperative.
Secondary outcome [1] 405546 0
Secondary outcome 1: patient reported wound healing outcomes using the Bluebelle Wound Experience Questionnaire.


Timepoint [1] 405546 0
Timepoint: Day 7 following surgery
Secondary outcome [2] 405547 0
Secondary outcome 2: quality of life assessed using the ED5QL Quality of Life Questionnaire
Timepoint [2] 405547 0
Timepoint: Baseline, and at Day 7 after surgery.

Eligibility
Key inclusion criteria
Consenting adult patient scheduled to undergo an abdominal procedure with an incision to the skin.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Allergy to DACC containing dressings
Urgent or emergency admissions

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Powered sample size based upon reduced occurrence rate of 50% at 80% confidence level, 5% margin of error, n=164. Assume 15% attrition rate (n=24), therefore a total of 188 per arm is required to meet minimum statistical requirements. Baseline descriptive statistics will be derived and a ROC statistic will be calculated to determine the predictive power of the surgical wound dehiscence risk assessment tool.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2023
Actual
Date of last participant enrolment
Anticipated
6/05/2024
Actual
Date of last data collection
Anticipated
10/06/2024
Actual
Sample size
Target
376
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23643 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 39064 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 310644 0
Commercial sector/Industry
Name [1] 310644 0
Essity/Abigo BSN Hamburg
Country [1] 310644 0
Germany
Primary sponsor type
University
Name
Murdoch University
Address
Murdoch University
Barry Marshall Drive
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 311867 0
None
Name [1] 311867 0
Address [1] 311867 0
Country [1] 311867 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 310241 0
Joondalup Health Campus
Ethics committee address [1] 310241 0
Ethics committee country [1] 310241 0
Australia
Date submitted for ethics approval [1] 310241 0
09/01/2023
Approval date [1] 310241 0
Ethics approval number [1] 310241 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116970 0
A/Prof Kylie Sandy-Hodgetts
Address 116970 0
Centre for Molecular Medicine & Innovative Therapeutics
Murdoch University
Barry Marshall Drive
Murdoch WA 6150
Country 116970 0
Australia
Phone 116970 0
+61435436747
Fax 116970 0
Email 116970 0
[email protected]
Contact person for public queries
Name 116971 0
Kylie Sandy-Hodgetts
Address 116971 0
Centre for Molecular Medicine & Innovative Therapeutics
Murdoch University
Barry Marshall Drive
Murdoch WA 6150
Country 116971 0
Australia
Phone 116971 0
+61435436747
Fax 116971 0
Email 116971 0
[email protected]
Contact person for scientific queries
Name 116972 0
Kylie Sandy-Hodgetts
Address 116972 0
Centre for Molecular Medicine & Innovative Therapeutics
Murdoch University
Barry Marshall Drive
Murdoch WA 6150
Country 116972 0
Australia
Phone 116972 0
+61435436747
Fax 116972 0
Email 116972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.