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

NCT ID: NCT03686904

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2020-02-14

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.

Conditions

Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SOC GROUP [Cohort A]

Debridement, SOC irrigation \& SOC topical gel

Group Type: PLACEBO_COMPARATOR

standard of care topical gel

Intervention Type: OTHER

standard of care topical gel (hydrocolloid topical gel)

Debridement

Intervention Type: PROCEDURE

Removing dead tissue from infected wound (in clinic)

Saline Irrigation (SOC Irrigation)

Intervention Type: OTHER

Normal Saline Irrigation (SOC Irrigation)

SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]

Debridement, benzalkonium irrigation \& SOC topical gel

Group Type: ACTIVE_COMPARATOR

standard of care topical gel

Intervention Type: OTHER

standard of care topical gel (hydrocolloid topical gel)

Debridement

Intervention Type: PROCEDURE

Removing dead tissue from infected wound (in clinic)

benzalkonium irrigation

Intervention Type: DRUG

washing and lavaging in clinic with benzalkonium irrigation

BLASTX and SALINE (SOC) GROUP [Cohort C]

Debridement, SOC saline irrigation \& benzalkonium gel

Group Type: ACTIVE_COMPARATOR

Benzalkonium Gel

Intervention Type: DRUG

antibiofilm solution (BlastX) topical wound gel

Debridement

Intervention Type: PROCEDURE

Removing dead tissue from infected wound (in clinic)

Saline Irrigation (SOC Irrigation)

Intervention Type: OTHER

Normal Saline Irrigation (SOC Irrigation)

BLASTX and TORRENTX GROUP [Cohort D]

Debridement, benzalkonium irrigation \& benzalkonium gel

Group Type: ACTIVE_COMPARATOR

Benzalkonium Gel

Intervention Type: DRUG

antibiofilm solution (BlastX) topical wound gel

Debridement

Intervention Type: PROCEDURE

Removing dead tissue from infected wound (in clinic)

benzalkonium irrigation

Intervention Type: DRUG

washing and lavaging in clinic with benzalkonium irrigation

Interventions

Benzalkonium Gel

antibiofilm solution (BlastX) topical wound gel

Intervention Type: DRUG

standard of care topical gel

standard of care topical gel (hydrocolloid topical gel)

Intervention Type: OTHER

Debridement

Removing dead tissue from infected wound (in clinic)

Intervention Type: PROCEDURE

benzalkonium irrigation

washing and lavaging in clinic with benzalkonium irrigation

Intervention Type: DRUG

Saline Irrigation (SOC Irrigation)

Normal Saline Irrigation (SOC Irrigation)

Intervention Type: OTHER

Other Intervention Names

BlastX; Topical Antibacterial gel; local debridement; TorrentX; SOC Irrigation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Next Science TM

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Attinger, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Georgetown University Hospital

Locations

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2018-0218

Identifier Type: -

Identifier Source: org_study_id