Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds
Condition: Wound Infection
MeSH terms: Wound Infection; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Benzalkonium Gel; standard of care topical gel; Debridement; benzalkonium irrigation; Saline Irrigation (SOC Irrigation)
Intervention type(s): Drug; Other; Procedure; Drug; Other
Intervention description(s): antibiofilm solution (BlastX) topical wound gel; standard of care topical gel (hydrocolloid topical gel); Removing dead tissue from infected wound (in clinic); washing and lavaging in clinic with benzalkonium irrigation; Normal Saline Irrigation (SOC Irrigation)
Other intervention name(s): BlastX; Topical Antibacterial gel; local debridement; TorrentX; SOC Irrigation
Intervention MeSH terms: Benzalkonium Compounds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment