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

The role of biofilm in causing wound infections and preventing healing is unclear.
Preliminary data suggests that persistent biofilm following excisional debridement may
re-inoculate clean wounds leading to infection. Additionally, this data also suggests that
persistent biofilm leads to chronic wound inflammation. Novel wound gels have been developed
which claim to disrupt biofilm and kill biofilm producing bacteria. Patients presenting with
a chronic wound will be randomized to receive treatment with a novel anti-biofilm solution
BlastX™(benzalkonium gel) or standard of care. All patients presenting with a chronic wound
(>4 weeks duration) will be assessed for eligibility in the study. If eligible, subjects will
be randomized into Cohort A (debridement, NS irrigation, SOC topical wound treatment), Cohort
B (debridement, benzalkonium irrigation, SOC topical wound treatment), Cohort C (debridement,
NS irrigation, and benzalkonium topical wound treatment) of Cohort D (debridement,
benzalkonium irrigation, and benzalkonium topical wound treatment). Subjects will receive
this treatment until the wound is completely healed or they are exited from the study.

Infection of chronic wounds is a multifactorial process involving the interplay between host
factors, the condition of the wound, and the number and virulence of bacterial species that
flourish and critically colonize in the tissue. 1 It is widely recognized that the
microorganisms colonizing in these wounds are biofilm producers. 2, 3, 4, 5 Biofilm is a
polymeric slime layer made up of polymeric sugars, microbial and/or host DNA, microbial
proteins and host molecules that encapsulate microorganisms.5 This limits the reach of the
host immune system and antibacterial agents. Biofilm formation has been associated with the
emergence of a diverse group of opportunistic pathogens, such as Staphylococcus aureus and
Pseudomonas aeruginosa, which contribute to recurrent infections by modifying environmental
parameters.4

Excisional debridement is the standard of care for chronic wound management and has shown to
be effective against biofilm. However, studies have shown that biofilm formation recurs
within 24hrs of debridement. Common topical wound preparations contain silver, iodine, honey,
or chlorhexidine; none of which have shown efficacy against biofilm.1 Recent studies have
reported that when targeting and disrupting the wound biofilm matrix, wound healing outcomes
are improved and there is a significant decrease in biofilm-related infections. 3, 5 To date,
there is no widely accepted topical agent which targets biofilm.

Preliminary and invitro studies have shown benzalkonium chloride to be an effective agent to
disrupt biofilm and prevent recolonization. An example of a commercially available
formulation of benzalkonium chloride is Benzalkonium gel wound gel and Benzalkonium solution
wound irrigation. There is insufficient clinical data suggesting whether a biofilm focused
approach is superior or inferior to standard of care treatment. In order to determine the
clinical efficacy of a biofilm-focused approached against current stand of care treatment,
this study outlines a clinical study evaluating the outcomes of patients treated with
Benzalkonium gel and Benzalkonium solution compared to standard of care wound gel and
irrigation.

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