NCT02181621

A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs

A Prospective, Open, Comparative, Randomized, Single-centre Study to Evaluate the Effect of Cadexomer Iodine Gel (IODOSORB) Compared to Standard Dressings (SOLOSITE) on Biofilm Disruption in Infected Diabetic Foot Ulcers (DFUs)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers. ◊ Trademark of Smith \& Nephew

Detailed description

IODOSORB gel is a cadexomer iodine product indicated for use in wet ulcers and wounds. As the use of IODOSORB has an anti-microbial effect and removes exudate continuously from the wound, a reduction in pain, odour, oedema, exudate, pus and debris, and microbial load including biofilm can be achieved, hence providing an environment conducive to the normal healing process. While evidence exists to support the use of IODOSORB in diabetic foot ulcers (DFUs) for the reduction of planktonic bacteria, little evidence exits for the effect of any topical therapy on non-planktonic or biofilm bacteria in-vivo. The aim of this study is to explore the effects of IODOSORB on biofilm in the wound, wound healing, and associated factors, such as odour, pain, and reduction of slough.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Iodosorb	Cadexomer iodine gel
DEVICE	Solosite gel	Hydrogel

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-07-04
• Last updated: 2024-02-29
• Results posted: 2024-02-29

Locations

1 site across 1 country: United States