N/A
N=49
The Clinical Efficacy of Next Science Wound Gel (NXTSC) in the Healing of Chronic Wounds
Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT02465073 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care — 62; 72; 47 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NXTSC wound gel (Device); NXTSC wound gel plus Standard of Care (Device); Standard of Care Group (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Southwest Regional Wound Care Center
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care |
62; 72; 47 | — |
Summary
Determine the effect on wound treatment outcomes using a novel antimicrobial wound gel (NXTSC) for the treatment of infected wounds as the sole topical treatment of microbial infection at the wound site.
Eligibility Criteria
Inclusion Criteria
- The subject must have a full-thickness chronic wound for greater than one month.
- The subject must be at least 18 years of age.
- The ulcer to be biopsied must be greater than 1 centimeter in area.
- The subject must be able to give informed consent.
Exclusion Criteria
- Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator.
- Those patients that have significant contributions from other disease processes such as arterial disease (Ankle Brachial Index [ABI] less than .7, OR Transcutaneous Partial Oxygen Pressure [TCpO2 ] less than 20) will be considered to have mixed vascular disease producing their wound and will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT02465073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.