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

NCT03686904 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-06-02

No results posted yet for this 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.

Conditions

  • Wound Infection

Interventions

DRUG

Benzalkonium Gel

antibiofilm solution (BlastX) topical wound gel

OTHER

standard of care topical gel

standard of care topical gel (hydrocolloid topical gel)

PROCEDURE

Debridement

Removing dead tissue from infected wound (in clinic)

DRUG

benzalkonium irrigation

washing and lavaging in clinic with benzalkonium irrigation

OTHER

Saline Irrigation (SOC Irrigation)

Normal Saline Irrigation (SOC Irrigation)

Sponsors & Collaborators

  • Next Science TM

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Christopher Attinger, MD · MedStar Georgetown University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2020-02-14
Completion
2020-02-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03686904 on ClinicalTrials.gov