Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers

Leg Ulcers Clinical Trial

Official title:

A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427491
• Other study ID #: CW-0142-11-U358
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2011
• Last updated: July 29, 2013
• Start date: August 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2013
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to manage bioburden in leg ulcers over a two week study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or over

• Willing and able to provide written informed consent

• Leg ulcer will be of size ranging between 10 cm2 - 40 cm2 with moderate or heavy exudate

• Leg ulcer will exhibit at least 2 of the 4 following clinical signs: pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour

Exclusion Criteria:

• Known skin sensitivity to any component of the products being tested

• Subjects who have had current local or systemic antibiotics and/or topical antimicrobials applied in the week prior to inclusion

• Depth of ulcer classified as superficial (not involving dermis) or deep (exposing muscle and tendon)

• Any other medical condition which, according to the investigator, justifies the subject's exclusion from the study

• Participated in a clinical study within the past 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Leg Ulcers
• Ulcer

Intervention

Device:
• Aquacel® Ag
Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.
• Mepilex® Border Ag
Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.

Locations

Country	Name	City	State
United Kingdom	Wound Healing Research Unit, Cardiff University	Cardiff	Wales
United Kingdom	Arrowe Park Hospital	Upton	Wirral
United Kingdom	The Willows Centre for Health Care	Weaste	Salford

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial load reduction	The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods.	Days 1 and 14	No
Secondary	clinical evolution of the wound (presence of each of the selected clinical signs)	Study's clinical signs: level of exudate (moderate or heavy at baseline), pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour	Days 1, 3, 7, 14	No
Secondary	Occurrence of adverse events		Day 1-14	No