Trial Outcomes & Findings for Skin and Soft Tissue Infection (SSTI) Study (NCT NCT02600871)
NCT ID: NCT02600871
Last Updated: 2018-10-30
Results Overview
Clinical cure was defined as improvement in the initial wound with respect to a decrease in measured size, erythema, and purulent discharge. Wound management at the follow up visits was left up to the discretion of the treating provider, but additional interventions for patients not clinically improving or worsening were considered a lack of clinical cure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
7-10 Days
Results posted on
2018-10-30
Participant Flow
Participant milestones
| Measure |
Provodine
Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine were applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.
Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.
Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and cover ed the wound with 4x4 gauze.
|
Standard Care
Standard care patients had standard care including incision and drainage.
Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.
Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
49
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
Reasons for withdrawal
| Measure |
Provodine
Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine were applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.
Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.
Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and cover ed the wound with 4x4 gauze.
|
Standard Care
Standard care patients had standard care including incision and drainage.
Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.
Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
10
|
Baseline Characteristics
Skin and Soft Tissue Infection (SSTI) Study
Baseline characteristics by cohort
| Measure |
Provodine
n=52 Participants
Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine applied with a Q-tip to the walls and floor of the abscess cavity. Contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.
Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.
Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze.
|
Standard Care
n=49 Participants
Standard care patients had standard care including incision and drainage.
Standard care patients returned at 48-72 hours for a follow-up visit and have the packing removed.
Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered the wound with 4x4 gauze and washed hands with soap and water for 1 minute.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Culture results
Other
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Culture results
Streptococcus
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Culture results
No growth
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
41.33 years
STANDARD_DEVIATION 14.82 • n=5 Participants
|
41.76 years
STANDARD_DEVIATION 13.57 • n=7 Participants
|
41.53 years
STANDARD_DEVIATION 14.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Abscess location
Trunk
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Abscess location
Extremity
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Abscess location
Groin/Buttock
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Abscess location
Axilla
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Abscess location
Head and Neck
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cellulitis
|
5 cm^2
n=5 Participants
|
5 cm^2
n=7 Participants
|
5 cm^2
n=5 Participants
|
|
Abscess size
|
18 cm^2
n=5 Participants
|
12 cm^2
n=7 Participants
|
15 cm^2
n=5 Participants
|
|
Culture results
MRSA
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Culture results
MSSA
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Culture results
Coag neg Staph
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-10 DaysClinical cure was defined as improvement in the initial wound with respect to a decrease in measured size, erythema, and purulent discharge. Wound management at the follow up visits was left up to the discretion of the treating provider, but additional interventions for patients not clinically improving or worsening were considered a lack of clinical cure.
Outcome measures
| Measure |
Provodine
n=51 Participants
Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.
Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.
Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze.
|
Standard Care
n=46 Participants
Standard care patients had standard care including incision and drainage.
Standard care patients returned within 48-72 hours for a follow-up visit and had the packing removed.
Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They then covered wound with 4x4 gauze and washed hands with soap and water for 1 minute.
|
|---|---|---|
|
Number of Participants With a Clinical Cure
|
45 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 30 DaysNew lesions (abscess, pustule, carbuncle, or furuncle) that developed in household contacts of subjects within 30 days of enrollment
Outcome measures
| Measure |
Provodine
n=39 Participants
Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.
Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.
Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze.
|
Standard Care
n=39 Participants
Standard care patients had standard care including incision and drainage.
Standard care patients returned within 48-72 hours for a follow-up visit and had the packing removed.
Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They then covered wound with 4x4 gauze and washed hands with soap and water for 1 minute.
|
|---|---|---|
|
Infection Rates of Household Contacts
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 DaysNew lesions, defined as a new abscess, pustule, carbuncle, or furuncle at least 5cm away from the initial wound, that developed in the subject within 30 days of enrollment
Outcome measures
| Measure |
Provodine
n=39 Participants
Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.
Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.
Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze.
|
Standard Care
n=41 Participants
Standard care patients had standard care including incision and drainage.
Standard care patients returned within 48-72 hours for a follow-up visit and had the packing removed.
Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They then covered wound with 4x4 gauze and washed hands with soap and water for 1 minute.
|
|---|---|---|
|
Rate of New Lesion Development
|
8 Participants
|
8 Participants
|
Adverse Events
Provodine
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Provodine
n=52 participants at risk
Provodine patients had standard care including incision and drainage. The contents of 1 packet of Provodine was applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a 2nd packet were applied to the surrounding skin within 5 cm around the incision.
Provodine patients returned at 48-72 hours for a follow-up visit, had the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.
Provodine patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They washed their hands with soap and water, patted dry, and applied the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rubbed together for 1 minute. They applied the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They rinsed their hands with water, patted dry, and covered the wound with 4x4 gauze.
|
Standard Care
n=49 participants at risk
Standard care patients had standard care including incision and drainage.
Standard care patients returned at 48-72 hours for a follow-up visit and had the packing removed.
Standard care patients were instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They covered wound with 4x4 gauze and washed hands with soap and water for 1 minute.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Burning/pain
|
34.6%
18/52 • Number of events 18 • 30 days
|
2.0%
1/49 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
13.5%
7/52 • Number of events 7 • 30 days
|
4.1%
2/49 • Number of events 2 • 30 days
|
|
Skin and subcutaneous tissue disorders
Tape irritation
|
13.5%
7/52 • Number of events 7 • 30 days
|
14.3%
7/49 • Number of events 7 • 30 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation around wound
|
7.7%
4/52 • Number of events 4 • 30 days
|
0.00%
0/49 • 30 days
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/52 • Number of events 1 • 30 days
|
0.00%
0/49 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/52 • Number of events 1 • 30 days
|
0.00%
0/49 • 30 days
|
|
Infections and infestations
Chills
|
1.9%
1/52 • Number of events 1 • 30 days
|
0.00%
0/49 • 30 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52 • 30 days
|
2.0%
1/49 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Decreased appetite
|
0.00%
0/52 • 30 days
|
2.0%
1/49 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/52 • 30 days
|
4.1%
2/49 • Number of events 2 • 30 days
|
Additional Information
Dr. Adriana Segura Olson
University of Texas Health San Antonio
Phone: 2152649796
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place