Trials / Withdrawn
WithdrawnNCT04084093
Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Medline Industries · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This will be an observational study evaluating subject's perception of pain to dressing changes during removal and application of a surfactant gel. Wound healing will also be monitored. Anxiety before dressing change will be measured using a burn specific pain anxiety scale. Study intervention will include cleansing the wound per the facility's standard of care, followed by applying the investigational product on the wound. This will be followed by placing an appropriate secondary dressing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Surfactant Gel | This device is helps in the creation of an optimal moist wound healing environment that aids in protecting healthy tissues and provides an environment conductive to autolytic debridement. The device is 100% water-soluble, biocompatible, and non-ionic. The dressing is a surfactant based gel. |
Timeline
- Start date
- 2020-02-12
- Primary completion
- 2020-04-08
- Completion
- 2020-04-08
- First posted
- 2019-09-10
- Last updated
- 2020-04-20
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04084093. Inclusion in this directory is not an endorsement.