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

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.

Study Overview

• Status: Withdrawn
• Conditions: Burns; Bacterial Infections; Infection Wound
• Intervention / Treatment: Procedure: Open-to-air strategy; Procedure: Traditional closed-wound management

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 to 89
2. Burn patients with TBSA≥ 20%
3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group; The experimental group will consist of wounds treated with the open-to-air strategy.	Procedure: Open-to-air strategy; 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.
Other: The control group; 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; 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.

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

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center

Publications and helpful links

General Publications

• Yang D, Davies A, Burge B, Watkins P, Dissanaike S. Open-to-Air Is a Viable Option for Initial Wound Care in Necrotizing Soft Tissue Infection that Allows Early Detection of Recurrence without Need for Painful Dressing Changes or Return to Operating Room. Surg Infect (Larchmt). 2018 Jan;19(1):65-70. doi: 10.1089/sur.2017.080. Epub 2017 Dec 6.
• Dai T, Gupta A, Huang YY, Yin R, Murray CK, Vrahas MS, Sherwood ME, Tegos GP, Hamblin MR. Blue light rescues mice from potentially fatal Pseudomonas aeruginosa burn infection: efficacy, safety, and mechanism of action. Antimicrob Agents Chemother. 2013 Mar;57(3):1238-45. doi: 10.1128/AAC.01652-12. Epub 2012 Dec 21.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): June 9, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Bacterial Infections and Mycoses; Burns; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: IRB #: L20-067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No