Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds
Primary Purpose
Wound Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Benzalkonium Gel
standard of care topical gel
Debridement
benzalkonium irrigation
Saline Irrigation (SOC Irrigation)
Sponsored by
About this trial
This is an interventional treatment trial for Wound Infection
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 18-99
- Chronic wound requiring debridement
- Wound located anywhere on the body
- Able to comply with clinical trial requirements
Exclusion Criteria:
- Patient unable or unwilling to comply with study requirements
- Disease or treatment causing substantial immunosuppression
- History of allergic reaction to benzalkonium
- Transplant recipient
Sites / Locations
- Medstar Georgetown University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
SOC GROUP [Cohort A]
SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]
BLASTX and SALINE (SOC) GROUP [Cohort C]
BLASTX and TORRENTX GROUP [Cohort D]
Arm Description
Debridement, SOC irrigation & SOC topical gel
Debridement, benzalkonium irrigation & SOC topical gel
Debridement, SOC saline irrigation & benzalkonium gel
Debridement, benzalkonium irrigation & benzalkonium gel
Outcomes
Primary Outcome Measures
Colony Forming Units Count Measure (Primary Measure)
The primary outcome is the change in CFU counts after treatment with Benzalkonium solution/Benzalkonium gel or SOC.
Secondary Outcome Measures
Change in index ulcer size measured in cm squared (Secondary endpoints)
Change in index ulcer size measured in cm squared
Duration of index ulcer measured in weeks (Secondary endpoints)
Duration of index ulcer measured in weeks
Full Information
NCT ID
NCT03686904
First Posted
August 2, 2018
Last Updated
May 31, 2022
Sponsor
Georgetown University
Collaborators
Next Science TM
1. Study Identification
Unique Protocol Identification Number
NCT03686904
Brief Title
Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds
Official Title
Investigating the Effect of an Anti-Biofilm Solution to Reduce Bacterial Burden and Accelerate Healing in Chronic Wounds.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
Next Science TM
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOC GROUP [Cohort A]
Arm Type
Placebo Comparator
Arm Description
Debridement, SOC irrigation & SOC topical gel
Arm Title
SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]
Arm Type
Active Comparator
Arm Description
Debridement, benzalkonium irrigation & SOC topical gel
Arm Title
BLASTX and SALINE (SOC) GROUP [Cohort C]
Arm Type
Active Comparator
Arm Description
Debridement, SOC saline irrigation & benzalkonium gel
Arm Title
BLASTX and TORRENTX GROUP [Cohort D]
Arm Type
Active Comparator
Arm Description
Debridement, benzalkonium irrigation & benzalkonium gel
Intervention Type
Drug
Intervention Name(s)
Benzalkonium Gel
Other Intervention Name(s)
BlastX
Intervention Description
antibiofilm solution (BlastX) topical wound gel
Intervention Type
Other
Intervention Name(s)
standard of care topical gel
Other Intervention Name(s)
Topical Antibacterial gel
Intervention Description
standard of care topical gel (hydrocolloid topical gel)
Intervention Type
Procedure
Intervention Name(s)
Debridement
Other Intervention Name(s)
local debridement
Intervention Description
Removing dead tissue from infected wound (in clinic)
Intervention Type
Drug
Intervention Name(s)
benzalkonium irrigation
Other Intervention Name(s)
TorrentX
Intervention Description
washing and lavaging in clinic with benzalkonium irrigation
Intervention Type
Other
Intervention Name(s)
Saline Irrigation (SOC Irrigation)
Other Intervention Name(s)
SOC Irrigation
Intervention Description
Normal Saline Irrigation (SOC Irrigation)
Primary Outcome Measure Information:
Title
Colony Forming Units Count Measure (Primary Measure)
Description
The primary outcome is the change in CFU counts after treatment with Benzalkonium solution/Benzalkonium gel or SOC.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in index ulcer size measured in cm squared (Secondary endpoints)
Description
Change in index ulcer size measured in cm squared
Time Frame
12 weeks
Title
Duration of index ulcer measured in weeks (Secondary endpoints)
Description
Duration of index ulcer measured in weeks
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Measurement of local perfusion using specialized noninvasive imaging (Tertiary endpoints)
Description
We will explore the association between the treatment and change in local perfusion using hyperspectral imaging.
Time Frame
12 weeks
Title
Measurement of time to heal subjects wounds
Description
Interaction of time with treatment and other baseline covariates will be included and tested
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 18-99
Chronic wound requiring debridement
Wound located anywhere on the body
Able to comply with clinical trial requirements
Exclusion Criteria:
Patient unable or unwilling to comply with study requirements
Disease or treatment causing substantial immunosuppression
History of allergic reaction to benzalkonium
Transplant recipient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Attinger, MD
Organizational Affiliation
MedStar Georgetown University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data was not collected for use in future research and will not be shared
Learn more about this trial
Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds
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