Trial Outcomes & Findings for Safety and Tolerability Study of Antimicrobial TheraGauze for Skin Abscess (NCT NCT02334384)
NCT ID: NCT02334384
Last Updated: 2018-10-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
1 week
Results posted on
2018-10-04
Participant Flow
Participant milestones
| Measure |
Antimicrobial TheraGauze
Antimicrobial 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.
Antimicrobial TheraGauze: In 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.
|
Standard Wound Packing
Standard wound packing will be used as the active comparator. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.
Antimicrobial TheraGauze: In 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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Antimicrobial TheraGauze
Antimicrobial 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.
Antimicrobial TheraGauze: In 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.
|
Standard Wound Packing
Standard wound packing will be used as the active comparator. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.
Antimicrobial TheraGauze: In 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Antimicrobial TheraGauze
n=4 Participants
Antimicrobial 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.
Antimicrobial TheraGauze: In 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.
|
Standard Wound Packing
n=2 Participants
Standard wound packing will be used as the active comparator. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.
Antimicrobial TheraGauze: In 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.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 12 • n=4 Participants
|
33 years
STANDARD_DEVIATION 12 • n=2 Participants
|
33 years
STANDARD_DEVIATION 12 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
|
Diameter of induration
|
32.5 mm
n=4 Participants
|
27.5 mm
n=2 Participants
|
30.8 mm
n=6 Participants
|
PRIMARY outcome
Timeframe: 1 weekEvaluate 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.
Outcome measures
| Measure |
Antimicrobial TheraGauze
n=4 Participants
Antimicrobial 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.
Antimicrobial TheraGauze: In 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.
|
Standard Wound Packing
n=2 Participants
Standard wound packing will be used as the active comparator. The ED physician will have the choice to use plain cotton wick or iodoform wick. Standard wound packing will be administered once.
Antimicrobial TheraGauze: In 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.
|
|---|---|---|
|
Number of Side-effects
|
4 Participants
|
2 Participants
|
Adverse Events
Antimicrobial TheraGauze
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Wound Packing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place