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

May 31, 2022 updated by: Georgetown University

Investigating the Effect of an Anti-Biofilm Solution to Reduce Bacterial Burden and Accelerate Healing in Chronic Wounds.

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: SOC GROUP [Cohort A]
Debridement, SOC irrigation & SOC topical gel
standard of care topical gel (hydrocolloid topical gel)
Other Names:
  • Topical Antibacterial gel
Removing dead tissue from infected wound (in clinic)
Other Names:
  • local debridement
Normal Saline Irrigation (SOC Irrigation)
Other Names:
  • SOC Irrigation
Active Comparator: SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]
Debridement, benzalkonium irrigation & SOC topical gel
standard of care topical gel (hydrocolloid topical gel)
Other Names:
  • Topical Antibacterial gel
Removing dead tissue from infected wound (in clinic)
Other Names:
  • local debridement
washing and lavaging in clinic with benzalkonium irrigation
Other Names:
  • TorrentX
Active Comparator: BLASTX and SALINE (SOC) GROUP [Cohort C]
Debridement, SOC saline irrigation & benzalkonium gel
Removing dead tissue from infected wound (in clinic)
Other Names:
  • local debridement
Normal Saline Irrigation (SOC Irrigation)
Other Names:
  • SOC Irrigation
antibiofilm solution (BlastX) topical wound gel
Other Names:
  • BlastX
Active Comparator: BLASTX and TORRENTX GROUP [Cohort D]
Debridement, benzalkonium irrigation & benzalkonium gel
Removing dead tissue from infected wound (in clinic)
Other Names:
  • local debridement
washing and lavaging in clinic with benzalkonium irrigation
Other Names:
  • TorrentX
antibiofilm solution (BlastX) topical wound gel
Other Names:
  • BlastX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colony Forming Units Count Measure (Primary Measure)
Time Frame: 12 weeks
The primary outcome is the change in CFU counts after treatment with Benzalkonium solution/Benzalkonium gel or SOC.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in index ulcer size measured in cm squared (Secondary endpoints)
Time Frame: 12 weeks
Change in index ulcer size measured in cm squared
12 weeks
Duration of index ulcer measured in weeks (Secondary endpoints)
Time Frame: 12 weeks
Duration of index ulcer measured in weeks
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of local perfusion using specialized noninvasive imaging (Tertiary endpoints)
Time Frame: 12 weeks
We will explore the association between the treatment and change in local perfusion using hyperspectral imaging.
12 weeks
Measurement of time to heal subjects wounds
Time Frame: 12 weeks
Interaction of time with treatment and other baseline covariates will be included and tested
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Christopher Attinger, MD, MedStar Georgetown University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2018

Primary Completion (Actual)

February 14, 2020

Study Completion (Actual)

February 14, 2020

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data was not collected for use in future research and will not be shared

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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