Clinical trial NCT04502914: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Burns
Infection Wound
Bacterial Infections
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The bacterial load at baseline for each treatment
timeFrame: At baseline
measure: The bacterial load on day 1 for each treatment
timeFrame: On day 1
measure: The bacterial load on day 2 for each treatment
timeFrame: On day 2
measure: Difference in change in bacterial load for day 1
timeFrame: Change in bacterial load from baseline and day 1
measure: Difference in change in bacterial load for day 2
timeFrame: Change in bacterial load from baseline and day 2
Secondary outcomes:
measure: Prevalence of bacterial species at baseline for each treatment
timeFrame: At baseline
measure: Prevalence of bacterial species on day 1 for each treatment
timeFrame: On day 1
measure: Prevalence of bacterial species on day 1 for each treatment
timeFrame: On day 2
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
References:
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.
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.