- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03686904
Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds
Investigating the Effect of an Anti-Biofilm Solution to Reduce Bacterial Burden and Accelerate Healing in Chronic Wounds.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- MedStar Georgetown University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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:
Removing dead tissue from infected wound (in clinic)
Other Names:
Normal Saline Irrigation (SOC Irrigation)
Other Names:
|
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:
Removing dead tissue from infected wound (in clinic)
Other Names:
washing and lavaging in clinic with benzalkonium irrigation
Other Names:
|
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:
Normal Saline Irrigation (SOC Irrigation)
Other Names:
antibiofilm solution (BlastX) topical wound gel
Other Names:
|
Active Comparator: BLASTX and TORRENTX GROUP [Cohort D]
Debridement, benzalkonium irrigation & benzalkonium gel
|
Removing dead tissue from infected wound (in clinic)
Other Names:
washing and lavaging in clinic with benzalkonium irrigation
Other Names:
antibiofilm solution (BlastX) topical wound gel
Other Names:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Attinger, MD, MedStar Georgetown University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Wound Infection
-
Pulmatrix Inc.TerminatedPost Operative Wound Infection | Postoperative Wound Infection-deepUnited States
-
Carilion ClinicSmith & Nephew, Inc.; DeRoyal Industries, Inc.CompletedImpaired Wound Healing | Postoperative Wound Infection-deepUnited States
-
PolyPid Ltd.CompletedPostoperative Wound Infection Superficial Incisional | Postoperative Wound Infection Deep Incisional Surgical SiteIsrael
-
Children's Healthcare of AtlantaWithdrawnPostoperative Wound InfectionUnited States
-
HITEC-Institute of Medical SciencesCompletedWound Infection | Wound Dehiscence | Wound Surgical | Wound BleedingPakistan
-
Universitat Internacional de CatalunyaHospital de GranollersCompletedSurgical Wound Infection | Postoperative Wound Infection | Postoperative Wound Infection Superficial Incisional | Preventive TherapySpain
-
Military Medical AcademyRecruitingPostoperative Wound Infection Superficial Incisional | Postoperative Wound Infection Deep Incisional Surgical SiteBulgaria
-
PfizerCompletedSurgical Wound Infection | Postoperative Wound Infection
-
Hospital for Special Surgery, New YorkNew York Presbyterian HospitalRecruitingSurgical Wound | Post Operative Wound InfectionUnited States
-
Brentwood Biomedical Research InstituteCompletedPostoperative Wound Infection | Traumatic Wound Infection | Closed Soft Tissue AbscessUnited States
Clinical Trials on standard of care topical gel
-
Integra LifeSciences CorporationIntegriumTerminatedDiabetic Foot UlcersUnited States, Puerto Rico, Canada, South Africa
-
Helsinn Healthcare SACompletedQuality of Life | RadiodermatitisItaly
-
Novan, Inc.CompletedAcne VulgarisUnited States
-
Glia, LLCCompletedContact Lens Discomfort | Contact Lens-induced Corneal Disorder | Contact Lens Acute Red Eye | Contact Lens-induced Corneal Fluorescein StainingUnited States
-
Rhodes Pharmaceuticals, L.P.ORA, Inc.Completed
-
MediWound LtdCompletedThermal BurnsUnited States, Israel, Belgium, Czechia, Georgia, Germany, Italy, Romania
-
Novan, Inc.CompletedAcne VulgarisUnited States
-
Maruho Co., Ltd.Leiden University Medical CenterCompletedCondylomata Acuminata (External)Netherlands
-
Maruho Co., Ltd.CompletedUsual Type Vulval Intraepithelial Neoplasia (uVIN)Netherlands