The Study on Bacterial Load Following Open-to-air Management in Burn Patients.
Primary Purpose
Burns, Infection Wound, Bacterial Infections
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open-to-air strategy
Traditional closed-wound management
Sponsored by
About this trial
This is an interventional treatment trial for Burns
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
Sites / Locations
- Texas Tech University Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
The experimental group
The control group
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04502914
First Posted
July 29, 2020
Last Updated
December 14, 2021
Sponsor
Texas Tech University Health Sciences Center
1. Study Identification
Unique Protocol Identification Number
NCT04502914
Brief Title
The Study on Bacterial Load Following Open-to-air Management in Burn Patients.
Official Title
The Study on Bacterial Load Following Open-to-air Management in Burn Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of subjects enrolled
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 9, 2021 (Actual)
Study Completion Date
June 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Infection Wound, Bacterial Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The experimental group
Arm Type
Experimental
Arm Description
The experimental group will consist of wounds treated with the open-to-air strategy.
Arm Title
The control group
Arm Type
Other
Arm Description
The control group will consist of wounds treated with traditional closed-wound management with dressings soaked in topical antimicrobial solutions.
Intervention Type
Procedure
Intervention Name(s)
Open-to-air strategy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional closed-wound management
Intervention Description
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.
Primary Outcome Measure Information:
Title
The bacterial load at baseline for each treatment
Description
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.
Time Frame
At baseline
Title
The bacterial load on day 1 for each treatment
Description
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.
Time Frame
On day 1
Title
The bacterial load on day 2 for each treatment
Description
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.
Time Frame
On day 2
Title
Difference in change in bacterial load for day 1
Description
Change in bacterial load from baseline and day 1 and compared between treatment and control groups.
Time Frame
Change in bacterial load from baseline and day 1
Title
Difference in change in bacterial load for day 2
Description
Change in bacterial load from baseline and day 2 and compared between treatment and control groups.
Time Frame
Change in bacterial load from baseline and day 2
Secondary Outcome Measure Information:
Title
Prevalence of bacterial species at baseline for each treatment
Description
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.
Time Frame
At baseline
Title
Prevalence of bacterial species on day 1 for each treatment
Description
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.
Time Frame
On day 1
Title
Prevalence of bacterial species on day 1 for each treatment
Description
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.
Time Frame
On day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29211657
Citation
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.
Results Reference
result
PubMed Identifier
23262998
Citation
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.
Results Reference
result
Learn more about this trial
The Study on Bacterial Load Following Open-to-air Management in Burn Patients.
We'll reach out to this number within 24 hrs