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临床试验/NCT02600871
NCT02600871已完成4 期

Skin and Soft Tissue Infection (SSTI) Study

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
101
试验地点
1
主要终点
Number of Participants With a Clinical Cure

研究概览

简要总结

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.

详细描述

Patients who meet criteria for the study will be enrolled by a convenience sample and randomized to a treatment group. Each patient will have a demographic data sheet completed by one of the study investigators or research associates. The data sheet will include contact information, age, gender, ethnicity, location of the abscess, measured length and width of palpable fluctuance and induration, measured length and width of surrounding cellulitis, presence or absence of fever, and previous medical history (including history of prior skin abscesses.) Assignment to a treatment group will be by blocked randomization.

All enrolled patients will be provided with an informed consent document and an overview of the study. Baseline measurements including size of abscess (measured by ruler of palpable fluctuance and induration) and maximal diameter of the largest area of cellulitis will be recorded. Providers will outline the area of palpable fluctuance with an Aspen skin marker and delineate the surrounding area of cellulitis with a dotted line to establish baseline surface area of wound. All patients will have standard care including incision and drainage and wound culture of the abscess cavity. All patients will receive local anesthesia and additional pain management will be left to the discretion of the treating provider. Providers will make a linear incision over the length of palpable fluctuance and induration. The provider will explore the wound cavity and break apart any loculations to allow for adequate drainage of purulent discharge. The provider will obtain wound cultures and irrigate with normal saline until clear irrigation fluid drains from cavity. Swabs will be sub-cultured on blood agar plates and grown overnight for bacterial identification and antibiotic susceptibility testing.

Patients randomized to Provodine will have the abscess cavity and surrounding skin gently painted with Provodine solution. The contents of one foil packet of Provodine will be applied with a Q-tip to the walls and floor of the abscess cavity. The contents of a second foil packet will be applied to the surrounding skin within 5 cm around the incision.

The abscess cavity of both groups will be gently packed with ¼ inch plain gauze strips and the wound will be covered with 4x4 gauze and secured with tape. Patients will be instructed to leave the wound packing in place and change the outer dressing once a day until they return at 48-72 hours for their first wound recheck.

Several studies have shown that there is no clinical benefit to antibiotics in the routine management of uncomplicated abscesses. Patients with uncomplicated abscesses (defined as palpable abscess < 5 cm in a healthy patient with no history of diabetes, HIV, IVDA or immunocompromised state who has no systemic signs of infection) will not be treated with antibiotics. Patients who do not meet these criteria will be treated with antibiotics at the discretion of the provider.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Skin abscess
  • Treatment requiring incision and drainage

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Provodine (Drug)

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.

干预措施: Incision and Drainage (Procedure)

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.

干预措施: Incision and Drainage (Procedure)

结局指标

主要结局

Number of Participants With a Clinical Cure

时间窗: 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.

次要结局

  • Rate of New Lesion Development(30 Days)
  • Infection Rates of Household Contacts(30 Days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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