The impact of bacterial binding dressings following colorectal surgery on surgical wound complications in an adult population.

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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622001492741

Acronym

CRISTINA

Enrollment

376

Registered

2022-11-29

Start date

2023-07-10

Completion date

2024-05-06

Last updated

2022-12-05

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

Conditions

None listed

Brief summary

Surgical wound complications such as surgical site infection or surgical wound dehiscence are a considerable burden to the patient, carer and provider. They result in delays to wound healing, reduced patient wellbeing, readmissions to acute care and clinical management in the primary and community nursing setting. Early identification is key to prevention and the use of dressings that reduce the bacterial load of the incision site may reduce the occurrence of wound complications after surgery. A randomised control trial is proposed to determine the efficacy of bacterial binding dressings for the prevention of surgical site infection and surgical wound dehiscence in an adult population undergoing abdominal surgery. The interventional dressing contains a fatty acid coating bacterial binding agent dialkylcarbamoylchloride (DACC) associated with reducing bacterial burden in chronic wounds. Unlike other antimicrobial dressings that rely upon a chemically active agent to reduce bioburden, DACC dressings use a mechanical rather than a chemical mode of action to reduce bioburden. Two arms will be investigated, one with the DACC dressings and a control arm using no DACC dressings. Participants will have a 14 day wear time of the dressing and will be followed up for a period of 30 days after their surgery including standard wound review meetings as per usual care. This study aims to determine the comparative efficacy of DACC containing dressings for the prevention of surgical wound complications following abdominal surgery in an adult cohort.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Consenting adult patient scheduled to undergo an abdominal procedure with an incision to the skin.

Exclusion criteria

Allergy to DACC containing dressings Urgent or emergency admissions

Outcome results