The Study on Bacterial Load Following Open-to-air Management in Burn Patients.

Study Overview
=================
Brief Summary
-----------------
Burns are one of the common forms of trauma and are a cause of unintentional death and injury. Management of burns becomes complex due to multiple associated complications, for instance, secondary infection of burn wounds is the most common complication associated with burn injuries. Treatment of bacterial infections with antibiotics is becoming more challenging due to the development of multidrug-resistance. Hence, there is a critical need to investigate and establish non-antibiotic approaches to prevent colonization, control growth, and eliminate bacteria from burn wounds. Recent studies have explored the beneficial effects of open-to-air strategies on wound healing. Based on the evidence, the investigators hypothesize that bacterial load in burn wounds will be lowered when treated with an open-to-air strategy compared to the traditional closed wound approach.

Detailed Description
-----------------
Burns are one of the common forms of trauma and are a cause of unintentional death and injury in the world as well as in the United States (US). Management of burns becomes complex due to multiple associated complications, which result in short-term and long-term disability. Secondary infection of burn wounds is the most common complication associated with burn injuries. Approximately 10,000 people die in the US due to burn-related infections. For instance, gram-negative Pseudomonas aeruginosa is an opportunistic organism commonly found in burn wounds. Bacterial infections cause prolonged hospital stay, increase morbidity, and mortality of burn patients. Treatment of bacterial infections with antibiotics is becoming more challenging due to the development of multidrug-resistance. Hence, current antibiotic regimens and wound care are not always successful in eliminating bacterial infections. As such, there is a critical need to investigate and establish non-antibiotic approaches to prevent colonization, control growth, and eliminate bacteria from burn wounds. Recent studies have explored the beneficial effects of open-to-air strategies on wound healing, especially in the presence of necrotizing infections. In an open-to air strategy, the wound is left open to the external environment with a heat lamp placed at 6 feet to promote drying. However, the spritz of a topical solution will be applied to avoid excessive drying. Based on current evidence, the investigators hypothesize that bacterial load in burn wounds will be lowered when treated with an open-to-air strategy compared to the traditional closed wound approach.

Official Title
-----------------
The Study on Bacterial Load Following Open-to-air Management in Burn Patients.

Conditions
-----------------
Burns, Infection Wound, Bacterial Infections

Intervention / Treatment
-----------------
* Procedure: Open-to-air strategy
* Procedure: Traditional closed-wound management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 89 Burn patients with TBSA≥ 20% Any suspicion of skin colonization or infection based on a positive result of microbiologic testing. Testing would only be performed if the attending surgeon treating the patient had a clinical suspicion of wound infection. Exclusion Criteria: 1. Children

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The experimental group will consist of wounds treated with the open-to-air strategy. The control group will consist of wounds treated with traditional closed-wound management with dressings soaked in topical antimicrobial solutions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The experimental group<br>The experimental group will consist of wounds treated with the open-to-air strategy. | Procedure: Open-to-air strategy<br>* In open-to-air management, the wound will be washed with a chlorhexidine solution and leave the wound open, or portion of the wound assigned to OTA, to the environment. An electric heat lamp (model no. 53103, 250W, Brandt Industries LLC, Bronx, NY) will be placed at as close to 1 yard (0.91 m) as possible from the wound after daily wound care for 24 hours (+/- 6 hours) to promote drying. However, to prevent excessive drying an hourly spritz of topical solution, e.g., DuoDERM® Hydroactive® gel (ConvaTec Oklahoma City, OK) will be used at the bedside.<br>|
| Other: The control group<br>The control group will consist of wounds treated with traditional closed-wound management with dressings soaked in topical antimicrobial solutions. | Procedure: Traditional closed-wound management<br>* In traditional closed-wound management, once a day the wound will be washed with a chlorhexidine solution and closed with a non-adherent dressing such as ADAPTIC® (Acelity, San Antonio, TX) soaked in topical antimicrobial solutions, ointments, and creams designed to promote wound healing.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The bacterial load at baseline for each treatment | Scrapings of the superficial wound exudate and debris will be obtained at baseline (i.e., the 0-time point before implementing any the tested wound care management option) from both wound sites of each patient. The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control. | At baseline | 
| The bacterial load on day 1 for each treatment | Scrapings of the superficial wound exudate and debris will be obtained on day 1 (about 24 hours after obtaining samples for baseline measurement) from both wound sites of each patient. The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control. | On day 1 | 
| The bacterial load on day 2 for each treatment | Scrapings of the superficial wound exudate and debris will be obtained on day 2 (about 48 hours after obtaining samples for baseline measurement) from both wound sites of each patient. The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control. | On day 2 | 
| Difference in change in bacterial load for day 1 | Change in bacterial load from baseline and day 1 and compared between treatment and control groups. | Change in bacterial load from baseline and day 1 | 
| Difference in change in bacterial load for day 2 | Change in bacterial load from baseline and day 2 and compared between treatment and control groups. | Change in bacterial load from baseline and day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of bacterial species at baseline for each treatment | Scrapings of the superficial wound exudate and debris will be obtained at baseline from both wound sites of each patient. Debridement samples will be homogenized and serially diluted.The dilutions will be spot plated on selective agar. | At baseline | 
| Prevalence of bacterial species on day 1 for each treatment | Scrapings of the superficial wound exudate and debris will be obtained at baseline on day 1 from both wound sites of each patient. Debridement samples will be homogenized and serially diluted.The dilutions will be spot plated on selective agar. | On day 1 | 
| Prevalence of bacterial species on day 1 for each treatment | Scrapings of the superficial wound exudate and debris will be obtained on day 2 from both wound sites of each patient. Debridement samples will be homogenized and serially diluted.The dilutions will be spot plated on selective agar. | On day 2 |