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

NCT03686904 | Completed Phase 4 FDA Drug

• 1 other identifier: 2018-0218
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• Change in index ulcer size measured in cm squared (Secondary endpoints)

  12 weeks

• Duration of index ulcer measured in weeks (Secondary endpoints)

  12 weeks

Other Outcomes (2)

• Measurement of local perfusion using specialized noninvasive imaging (Tertiary endpoints)

  12 weeks

• Measurement of time to heal subjects wounds

  12 weeks

Study Arms (4)

SOC GROUP [Cohort A]

PLACEBO COMPARATOR

Debridement, SOC irrigation \& SOC topical gel

Other: standard of care topical gel; Procedure: Debridement; Other: Saline Irrigation (SOC Irrigation)

SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]

ACTIVE COMPARATOR

Debridement, benzalkonium irrigation \& SOC topical gel

Other: standard of care topical gel; Procedure: Debridement; Drug: benzalkonium irrigation

BLASTX and SALINE (SOC) GROUP [Cohort C]

ACTIVE COMPARATOR

Debridement, SOC saline irrigation \& benzalkonium gel

Drug: Benzalkonium Gel; Procedure: Debridement; Other: Saline Irrigation (SOC Irrigation)

BLASTX and TORRENTX GROUP [Cohort D]

ACTIVE COMPARATOR

Debridement, benzalkonium irrigation \& benzalkonium gel

Drug: Benzalkonium Gel; Procedure: Debridement; Drug: benzalkonium irrigation

Interventions

Benzalkonium Gel DRUG

antibiofilm solution (BlastX) topical wound gel

Also known as: BlastX

BLASTX and SALINE (SOC) GROUP [Cohort C]; BLASTX and TORRENTX GROUP [Cohort D]

standard of care topical gel OTHER

standard of care topical gel (hydrocolloid topical gel)

Also known as: Topical Antibacterial gel

SOC GROUP [Cohort A]; SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]

Debridement PROCEDURE

Removing dead tissue from infected wound (in clinic)

Also known as: local debridement

BLASTX and SALINE (SOC) GROUP [Cohort C]; BLASTX and TORRENTX GROUP [Cohort D]; SOC GROUP [Cohort A]; SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]

benzalkonium irrigation DRUG

washing and lavaging in clinic with benzalkonium irrigation

Also known as: TorrentX

BLASTX and TORRENTX GROUP [Cohort D]; SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]

Saline Irrigation (SOC Irrigation) OTHER

Normal Saline Irrigation (SOC Irrigation)

Also known as: SOC Irrigation

BLASTX and SALINE (SOC) GROUP [Cohort C]; SOC GROUP [Cohort A]

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18-99
• Chronic wound requiring debridement
• Wound located anywhere on the body
• Able to comply with clinical trial requirements

You may not qualify if:

• Patient unable or unwilling to comply with study requirements
• Disease or treatment causing substantial immunosuppression
• History of allergic reaction to benzalkonium
• Transplant recipient

Sponsors & Collaborators

• Georgetown University: lead
• Next Science TM: collaborator

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Wound Infection

Interventions

Debridement

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Christopher Attinger, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: September 27, 2018
• Study Start: November 19, 2018
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: June 2, 2022

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)