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Antimicrobial TheraGauze

Phase 1

Furunculosis | Monoclonal antibody | Other |Bioventus Inc.|Last Updated: Oct 4, 2018

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Antimicrobial TheraGauze · 1 trial · 1 indication

Phase 1 1
NCT02334384Safety and Tolerability Study of Antimicrobial TheraGauze for Skin AbscessFurunculosis
COMPLETED6 Analytics
PHASE1COMPLETED
Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess
FurunculosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Side-effects
1 week

Evaluate for evidence of side-effects from Antimicrobial TheraGauze packing of skin abscess wounds compared with standard of care (i.e. cotton wick or iodoform wick). Tests for statistical significance will be made for multiple potential side-effects including: 1) erythema around the wound packing, 2) increased pain at the wound site, 3) increased tenderness around the wound 4) increased discharge from the wound, 4) new rash, and 5) fever.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Antimicrobial TheraGauzeEXPERIMENTALAntimicrobial TheraGauze (i.e. tobramycin impregnated TheraGauze) will be used as a wound packing after incision and drainage of skin abscess (i.e. furunculosis). Antimicrobial TheraGauze will be administered once.
Standard of care - standard wound packingNO_INTERVENTIONIn this control arm the subject will receive standard of care with standard wound packing. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.

Interventions

NameTypeDescription
Antimicrobial TheraGauzeBIOLOGICALIn the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess. In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Ages \>18 to \<65 years at time of enrollment * Subject has skin abscess requiring incision and drainage * Male or female * Ability to read and understand the English language at a level sufficient to provide informed consent and comply with study requirements * Subject is wil...

Countries:United States
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