Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds

• Status: Active, not recruiting
• Trial end date: 2020-02-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, double-blinded, single site study examining the impact of a biofilm-based treatment of chronic wounds of the lower extremity. 200 subjects will be enrolled in this study. Benzalkonium solution wound irrigation and Benzalkonium wound gel will be compared to standard of care wound preparation and dressing (NS wound irrigation and hydrocolloid gel) following local debridement. Wounds will be assessed maximum of 12 weeks with a minimum of 4 follow up visits. Patients will be recruited from the general wound clinic population. No enticement will be offered and participation will be completely voluntary. At enrollment and at each follow up visit the wound will be assessed for size (length, width, and depth), signs of infection or irritation, qualitative and quantitative cultures will be taken before and after debridement, patients will be assessed for compliance to the treatment protocol, satisfaction with their treatment, any adverse effects of the treatment, and hospitalizations since last assessment. It is anticipated that enrollment and completion of the study will take 1 year.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Next Science TM
• Treatments: Benzalkonium Compounds

Criteria

Inclusion Criteria:

1. Male or female, aged 18-99

2. Chronic wound requiring debridement

3. Wound located anywhere on the body

4. Able to comply with clinical trial requirements

Exclusion Criteria:

1. Patient unable or unwilling to comply with study requirements

2. Disease or treatment causing substantial immunosuppression

3. History of allergic reaction to benzalkonium

4. Transplant recipient