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Skin and Soft Tissue Infection (SSTI) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600871
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : March 27, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief Summary:
The purpose of this study is to determine if the use Provodine as an antiseptic and hand wash once daily for at least 7 days will have better healing, better health outcomes, fewer treatment failures and fewer infections themselves and among their household contacts than those who do not use Provodine.

Condition or disease Intervention/treatment Phase
Skin Diseases, Infectious Soft Tissue Infections Drug: Provodine Procedure: Incision and Drainage Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Provodine

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.

Drug: Provodine
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Skin abscess
  • Treatment requiring incision and drainage

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Homeless, incarcerated, or living in a group home
  • Abscess on the face or breast
  • Abscess requiring surgical drainage in the operating room or requiring admission to the hospital
  • Intravenous drug users
  • Previous enrollment in this study
  • Documented history of iodine sensitivity

Information from the National Library of Medicine

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


Locations
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United States, Texas
University Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
  Study Documents (Full-Text)

Documents provided by The University of Texas Health Science Center at San Antonio:
Publications:
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02600871    
Other Study ID Numbers: HSC20150722H
First Posted: November 9, 2015    Key Record Dates
Results First Posted: March 27, 2018
Last Update Posted: October 30, 2018
Last Verified: February 2018
Keywords provided by The University of Texas Health Science Center at San Antonio:
Abscess
Antiseptic
Provodine
Povidone-Iodine
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Soft Tissue Infections
Skin Diseases, Infectious
Skin Diseases
Povidone-Iodine
Povidone
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents