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BLASTX and TORRENTX GROUP [Cohort D] for Wound Infection

Phase 4
Waitlist Available
Led By Christopher Attinger, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

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.

Eligible Conditions
  • Wound Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Colony Forming Units Count Measure (Primary Measure)
Secondary outcome measures
Change in index ulcer size measured in cm squared (Secondary endpoints)
Duration of index ulcer measured in weeks (Secondary endpoints)
Other outcome measures
Measurement of local perfusion using specialized noninvasive imaging (Tertiary endpoints)
Measurement of time to heal subjects wounds

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: BLASTX and TORRENTX GROUP [Cohort D]Active Control3 Interventions
Debridement, benzalkonium irrigation \& benzalkonium gel
Group II: BLASTX and SALINE (SOC) GROUP [Cohort C]Active Control3 Interventions
Debridement, SOC saline irrigation \& benzalkonium gel
Group III: SOC TOPICAL GEL & TORRENT X GROUP [Cohort B]Active Control3 Interventions
Debridement, benzalkonium irrigation \& SOC topical gel
Group IV: SOC GROUP [Cohort A]Placebo Group3 Interventions
Debridement, SOC irrigation \& SOC topical gel

Find a Location

Who is running the clinical trial?

Next Science TMIndustry Sponsor
15 Previous Clinical Trials
9,513 Total Patients Enrolled
3 Trials studying Wound Infection
66 Patients Enrolled for Wound Infection
Georgetown UniversityLead Sponsor
346 Previous Clinical Trials
137,199 Total Patients Enrolled
3 Trials studying Wound Infection
350 Patients Enrolled for Wound Infection
Christopher Attinger, MDPrincipal InvestigatorMedStar Georgetown University Hospital
6 Previous Clinical Trials
569 Total Patients Enrolled
2 Trials studying Wound Infection
350 Patients Enrolled for Wound Infection
~2 spots leftby Sep 2025