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NCT03686904 · ClinicalTrials.gov registry record · Phase 4
Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds
A Phase 4 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT03686904 is a Phase 4 study that has completed, run by Georgetown University. The registered enrollment target is 11 participants.
The verdict
NCT03686904, a Phase 4 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Debridement
- DRUG Benzalkonium Gel
- OTHER standard of care topical gel
- DRUG benzalkonium irrigation
- OTHER Saline Irrigation (SOC Irrigation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2020-02-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03686904
The ClinicalTrials.gov registry entry for NCT03686904 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Debridement is the first listed.
NCT03686904 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03686904 about?
NCT03686904 is a clinical study titled "Investigation of a Novel Wound Gel to Improve Wound Healing in Chronic Wounds". 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...
What is the current status of trial NCT03686904?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2018-11-19. Estimated completion is 2020-02-14.
What interventions are being tested in trial NCT03686904?
The interventions under investigation include: Debridement (PROCEDURE), Benzalkonium Gel (DRUG), standard of care topical gel (OTHER), benzalkonium irrigation (DRUG), Saline Irrigation (SOC Irrigation) (OTHER).
Who is sponsoring clinical trial NCT03686904?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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