Phase 4
N=101
Skin and Soft Tissue Infection (SSTI) Study
Skin Diseases, Infectious · Soft Tissue Infections
Bottom Line
View on ClinicalTrials.gov: NCT02600871 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Number of Participants With a Clinical Cure — 45; 42 Participants — p=0.71
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Provodine (Drug); Incision and Drainage (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Clinical Cure |
45; 42 | 0.71 |
| SECONDARY Infection Rates of Household Contacts |
2; 4 | — |
| SECONDARY Rate of New Lesion Development |
8; 8 | — |
Summary
The purpose of this study is to determine if the use Provodine as an antiseptic and hand wash once daily for at least 7 days will have better healing, better health outcomes, fewer treatment failures and fewer infections themselves and among their household contacts than those who do not use Provodine.
Eligibility Criteria
Inclusion Criteria
- Skin abscess
- Treatment requiring incision and drainage
Exclusion Criteria
- Unable or unwilling to provide informed consent
- Homeless, incarcerated, or living in a group home
- Abscess on the face or breast
- Abscess requiring surgical drainage in the operating room or requiring admission to the hospital
- Intravenous drug users
- Previous enrollment in this study
- Documented history of iodine sensitivity
Data sourced from ClinicalTrials.gov (NCT02600871). 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.