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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04502914
• Other study ID #: IRB #: L20-067
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 9, 2021

Study information

• Verified date: December 2021
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Burns
• Communicable Diseases
• Infection Wound
• Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Ma — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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