Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686904
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
Next Science TM
Information provided by (Responsible Party):
Georgetown University

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.

Condition or disease Intervention/treatment Phase
Wound Infection Drug: Benzalkonium Gel Other: standard of care topical gel Procedure: Debridement Drug: benzalkonium irrigation Other: Saline Irrigation (SOC Irrigation) Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigating the Effect of an Anti-Biofilm Solution to Reduce Bacterial Burden and Accelerate Healing in Chronic Wounds.
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: SOC GROUP [Cohort A]
Debridement, SOC irrigation & SOC topical gel
Other: standard of care topical gel
standard of care topical gel (hydrocolloid topical gel)
Other Name: Topical Antibacterial gel

Procedure: Debridement
Removing dead tissue from infected wound (in clinic)
Other Name: local debridement

Other: Saline Irrigation (SOC Irrigation)
Normal Saline Irrigation (SOC Irrigation)
Other Name: SOC Irrigation

Active Comparator: SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]
Debridement, benzalkonium irrigation & SOC topical gel
Other: standard of care topical gel
standard of care topical gel (hydrocolloid topical gel)
Other Name: Topical Antibacterial gel

Procedure: Debridement
Removing dead tissue from infected wound (in clinic)
Other Name: local debridement

Drug: benzalkonium irrigation
washing and lavaging in clinic with benzalkonium irrigation
Other Name: TorrentX

Active Comparator: BLASTX and SALINE (SOC) GROUP [Cohort C]
Debridement, SOC saline irrigation & benzalkonium gel
Drug: Benzalkonium Gel
antibiofilm solution (BlastX) topical wound gel
Other Name: BlastX

Procedure: Debridement
Removing dead tissue from infected wound (in clinic)
Other Name: local debridement

Other: Saline Irrigation (SOC Irrigation)
Normal Saline Irrigation (SOC Irrigation)
Other Name: SOC Irrigation

Active Comparator: BLASTX and TORRENTX GROUP [Cohort D]
Debridement, benzalkonium irrigation & benzalkonium gel
Drug: Benzalkonium Gel
antibiofilm solution (BlastX) topical wound gel
Other Name: BlastX

Procedure: Debridement
Removing dead tissue from infected wound (in clinic)
Other Name: local debridement

Drug: benzalkonium irrigation
washing and lavaging in clinic with benzalkonium irrigation
Other Name: TorrentX




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in index ulcer size measured in cm squared (Secondary endpoints) [ Time Frame: 12 weeks ]
    Change in index ulcer size measured in cm squared

  2. Duration of index ulcer measured in weeks (Secondary endpoints) [ Time Frame: 12 weeks ]
    Duration of index ulcer measured in weeks


Other Outcome Measures:
  1. 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.

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686904


Contacts
Layout table for location contacts
Contact: Elliot Walters 12024446735 elliot.t.walters@gunet.georgetown.edu

Locations
Layout table for location information
United States, District of Columbia
Medstar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Christopher Attinger, MD    202-444-3059      
Principal Investigator: Christopher Attinger, MD         
Sponsors and Collaborators
Georgetown University
Next Science TM
Investigators
Layout table for investigator information
Principal Investigator: Christopher Attinger, MD MedStar Georgetown University Hospital

Layout table for additonal information
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT03686904     History of Changes
Other Study ID Numbers: 2018-0218
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data was not collected for use in future research and will not be shared

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Wound Infection
Wounds and Injuries
Infection
Benzalkonium Compounds
Anti-Infective Agents, Local
Anti-Infective Agents