The efficacy of low-frequency ultrasonic debridement (LFUD) and Polyhexamethylene Biguanide (PHMB) combination therapy for adults with chronic wounds; a randomised controlled trial

Phase 3

Completed

• Conditions: Chronic wounds; Infection - Studies of infection and infectious agents; Skin - Other skin conditions

• Registration Number: ACTRN12617001291370
• Lead Sponsor: Marianne Wallis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-06
• Study Completion: 2019-10-21
• Last Update Posted: 18 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Adults 18 years plus
Chronic wound for more than 6 weeks
Wound suitable for debridement therapy

Exclusion Criteria

Cognitive deficit
Malignant wound or systemic condition
spreading infection in the wound
autoimmune disease
Type 1 diabetes
sensitivity to PHMB
pregnancy
cartilage exposed in the wound
wound size < 2 cm 2 , or > 100 cm 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacterial counts measured via colony forming units (CFUs) from swab cultures. <br><br>[CFUs will be assessed at baseline, week 3, 6 & 12.<br><br>];A change in visual signs of wound biofilm/chronic infection via a newly designed Visual Biofilm Tool.[Clinical signs of biofilm will be assessed at baseline, week 6 and at week 12. ];Wound biofilm associated with the bacterial burden measured via molecular techniques: polymicrobial numbers from DNA sequencing from swab cultures and tissue samples.[At baseline, 6 weeks and 12 weeks. ]