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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02127658
Other study ID # 1R24HS022434-01, 1305011439
Secondary ID 1R24HS022434-01
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date February 2019

Study information

Verified date July 2018
Source Indiana University
Contact Paul I Musey, MD
Phone 3178803900
Email pmusey@iu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the investigators intend to compare therapies (abscess surgery and hygiene education compared to abscess surgery and hygiene education followed by decolonization) for Methicillin-Resistant Staphylococcus Aureus skin and soft tissue infections (MRSA SSTI) to determine which is the more effective treatment. The investigators focus on patient centered outcomes as described by the families of MRSA infected patients. Such outcomes are likely to include quality of life, side effects, and school and work attendance. The hypothesis is that treatment with decolonization will decrease the rate of SSTI recurrence and improve overall patient centered outcomes. The rationale is that negative outcomes such as recurrence may be avoided through the use of readily available prevention strategies, but that it is important to determine how burdensome those prevention strategies are for patients and families.


Recruitment information / eligibility

Status Recruiting
Enrollment 190
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Years
Eligibility Inclusion Criteria:

- Children/youth ages 3 months - 18 years seen in the Riley Pediatric Surgery Outpatient Clinic for a follow up visit within two weeks of the incision and drainage of a culture-confirmed MRSA abscess (regardless of where the abscess was drained)

- Children/youth ages 3 months - 18 years who had an incision and drainage of a culture-confirmed MRSA abscess in the Riley Emergency Department or Riley Operating Room within the two weeks prior to enrollment

- Household members of the patient who are between the ages 3 months - 64 years

Exclusion Criteria:

- Children in need of additional abscess surgery

- Documented immune deficiency

- Previous burn victims

- Self reported history of sensitivity to chlorine bleach or mupirocin

- Families without a bathtub

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hygiene education
Participants will receive specific hygiene instructions according to existing recommendations.
Hygiene education and Decolonization
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite [Clorox; The Clorox Company] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupiricin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days

Locations

Country Name City State
United States Pediatric Surgery Outpatient Clinic, Riley Outpatient Center, Riley Hospital for Children, Indiana University Health Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Side effects adverse events 6 months
Other Participant time committed to intervention The investigators will ask parents to estimate the amount of time (in hours) per week they estimate the intervention took for all family members combined 6 weeks
Other Quality of Life Quality of Life Impact on quality of life will be measured by the use of Peds QL, Pediatric Quality of Life Inventory. 12 months
Other Impact on school attendance Parents of participants will be asked whether their child have missed any school days due to MRSA SSTI. Parents will be asked about number of school days missed. 12 months
Other Adherence to Intervention Adherence will be reported on a 5 point scale for child and other family members separately:
"I always did the hygiene recommendations/bleach baths/mupirocin as recommended".
"I sometimes didn't do the hygiene recommendations/bleach baths/mupirocin knowingly or unknowingly, but never omitted more than one time/dose/bath in a row" "I sometimes didn't do the hygiene recommendations/bleach baths/mupirocin knowingly or unknowingly, but never omitted more than one day/week in a row" "I missed hygiene recommendations/bleach baths/mupirocin, knowingly or unknowingly, for two or more days/weeks in a row".
"I missed most hygiene recommendations/bleach baths/mupirocin, knowingly or unknowingly."
6 weeks
Other Impact on parents' work attendance frequency of work absences due to child's MRSA infection 12 months
Primary Recurrence of skin and soft tissue infection frequency of recurrence 12 months
Secondary Repeat surgery frequency of repeated surgical procedures 12 months
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