A feasibility study comparing topical use of acetic acid at the exit site versus mupirocin to prevent exit site infections in peritoneal dialysis patients.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001286336

Acronym

ACES Study

Enrollment

Registered

2017-09-06

Start date

2018-02-13

Completion date

2019-02-25

Last updated

2021-01-05

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

Conditions

None listed

Brief summary

PD catheter ESI is a major predisposing factor to PD peritonitis and resultant catheter and modality failure. The two most frequent causative organisms of ESI are Staphylococcus aureus (SA) and Pseudomonas aeruginosa. Daily topical application of an antibiotic cream such as mupirocin is the standard of care, however this agent is not anti-pseudomonal and may promote antibiotic resistance. Acetic acid at low concentrations is non=toxic to humans and non-irritant, but has broad antimicrobial activity including against Pseudomonas aeruginosa and may therefore offer a cheap and effective alternative. It has a long history in chronic wound care for this purpose. In this trial we will investigate the feasibility of the use of daily acetic acid dressings to reduce exit site infection, in comparison to the use of standard mupirocin treatment.

Interventions

Group 1 (intervention): routine exit site cleaning + topical acetic acid Group 2(control group - standard care): routine exit site cleaning + topical mupirocin Routine exit site (ES) cleaning involves: Cleaning ES in the shower with a packet of sterile gauze with antibacterial soap and water, drying the ES after the shower with sterile gauze then sunning ES for 10 minutes where possible. Topical mupirocin involves: application of small amount (approx.. 1/4 pea size) of Mupirocin ointment 2% with cotton tip, after cleaning and sunning of ES (as described above). Topical acetic acid involves: application of sterile gauze soaked with 2% acetic acid (approximately 5ml) for 10 minutes contact time to the ES after cleaning and sunning of ES as above. Exit site cares (including the intervention and control treatment) are performed daily in the morning and for the duration of the trial (12 months). Exit site cares are administered by the patient.

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 No maximum

Healthy volunteers

Inclusion criteria

All adult patients undergoing peritoneal dialysis under the catchement area of the Royal Brisbane and Women's Hospital. No active peritonitits or exit site infection. Ability to comply with exit site cares.

Exclusion criteria

Active infection. Inability to comply with exit site cares.

Outcome results