Skin and Soft Tissue Infection (SSTI) Study
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|ClinicalTrials.gov Identifier: NCT02600871|
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : March 27, 2018
Last Update Posted : October 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Skin Diseases, Infectious Soft Tissue Infections||Drug: Provodine Procedure: Incision and Drainage||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Skin and Soft Tissue Infection (SSTI) Study|
|Actual Study Start Date :||December 2015|
|Actual Primary Completion Date :||April 30, 2017|
|Actual Study Completion Date :||May 30, 2017|
Provodine patients will have 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. The contents of a 2nd packet will be applied to the surrounding skin within 5 cm around the incision.
Provodine patients will return within 48-72 hours for a follow-up visit, have the packing removed and the contents of the packet reapplied to the abscess cavity and surrounding skin.
Provodine patients will be instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They will wash their hands with soap and water, pat dry, and apply the contents of 1 packet of Provodine to dorsum and palmar aspects of hands and fingers and rub together for 1 minute. They will apply the contents of a 2nd packet to the abscess cavity, and a 3rd packet to the surrounding skin. They will be then rinse their hands with water, pat dry, and cover the wound with 4x4 gauze.
Other Name: Povidone-Iodine
Procedure: Incision and Drainage
Active Comparator: Standard Care
Standard care patients will have standard care including incision and drainage.
Standard care patients will return within 48-72 hours for a follow-up visit and have the packing removed.
Standard care patients will be instructed to cleanse the abscess at home by soaking in water once a day and patting the wound dry. They will cover wound with 4x4 gauze and wash hands with soap and water for 1 minute.
Procedure: Incision and Drainage
- Number of Participants With a Clinical Cure [ Time Frame: 7-10 Days ]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.
- Infection Rates of Household Contacts [ Time Frame: 30 Days ]New lesions (abscess, pustule, carbuncle, or furuncle) that developed in household contacts of subjects within 30 days of enrollment
- Rate of New Lesion Development [ Time Frame: 30 Days ]New 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600871
|United States, Texas|
|San Antonio, Texas, United States, 78229|