Skin and Soft Tissue Infection (SSTI) Study

NCT02600871 | Completed Phase 4 Results

• 1 other identifier: HSC20150722H
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Diseases, Infectious; Soft Tissue Infections

Keywords

Abscess; Antiseptic; Provodine; Povidone-Iodine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Clinical Cure

  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.

  7-10 Days

Secondary Outcomes (2)

• Infection Rates of Household Contacts

  30 Days

• Rate of New Lesion Development

  30 Days

Study Arms (2)

Provodine

EXPERIMENTAL

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; Procedure: Incision and Drainage

Standard Care

ACTIVE COMPARATOR

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

Interventions

Provodine DRUG

Also known as: Povidone-Iodine

Provodine

Incision and Drainage PROCEDURE

Provodine; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Skin abscess
• Treatment requiring incision and drainage

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

• Labreche MJ, Lee GC, Attridge RT, Mortensen EM, Koeller J, Du LC, Nyren NR, Trevino LB, Trevino SB, Pena J, Mann MW, Munoz A, Marcos Y, Rocha G, Koretsky S, Esparza S, Finnie M, Dallas SD, Parchman ML, Frei CR. Treatment failure and costs in patients with methicillin-resistant Staphylococcus aureus (MRSA) skin and soft tissue infections: a South Texas Ambulatory Research Network (STARNet) study. J Am Board Fam Med. 2013 Sep-Oct;26(5):508-17. doi: 10.3122/jabfm.2013.05.120247.

  PMID: 24004702 BACKGROUND

• Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26.

  PMID: 20346539 BACKGROUND

• Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann Emerg Med. 2010 May;55(5):401-7. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5.

  PMID: 19409657 BACKGROUND

MeSH Terms

Conditions

Skin Diseases, Infectious; Soft Tissue Infections; Abscess

Interventions

Povidone-Iodine; Drainage

Condition Hierarchy (Ancestors)

Infections; Skin Diseases; Skin and Connective Tissue Diseases; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Therapeutics; Surgical Procedures, Operative

Limitations and Caveats

The low sample size of subjects was insufficient to perform a power calculation. Not all patients were compliant with hand washing and Provodine use. The 30-day follow phone call was self-reported, and not all subjects could be contacted.

Results Point of Contact

• Title: Dr. Adriana Segura Olson
• Organization: University of Texas Health San Antonio

adriana.s.olson@gmail.com

2152649796

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: December 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: May 30, 2017
• Last Updated: October 30, 2018
• Results First Posted: March 27, 2018

Record last verified: 2018-02

Locations

US (1)