Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds
Public ClinicalTrials.gov record NCT03686904. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Investigating the Effect of an Anti-Biofilm Solution to Reduce Bacterial Burden and Accelerate Healing in Chronic Wounds.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03686904
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 11 participants
Conditions and interventions
Conditions
Interventions
- Benzalkonium Gel Drug
- standard of care topical gel Other
- Debridement Procedure
- benzalkonium irrigation Drug
- Saline Irrigation (SOC Irrigation) Other
Drug · Other · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 18, 2018
- Primary completion
- Feb 13, 2020
- Completion
- Feb 13, 2020
- Last update posted
- Jun 1, 2022
2018 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03686904, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 1, 2022 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03686904 live on ClinicalTrials.gov.