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

NCT04502914 | Withdrawn DMC

• 1 other identifier: IRB #: L20-067
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Infection Wound; Bacterial Infections

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Prevalence of bacterial species at baseline for each treatment

  At baseline

• Prevalence of bacterial species on day 1 for each treatment

  On day 1

• Prevalence of bacterial species on day 1 for each treatment

  On day 2

Study Arms (2)

The experimental group

EXPERIMENTAL

The experimental group will consist of wounds treated with the open-to-air strategy.

Procedure: Open-to-air strategy

The control group

OTHER

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

Interventions

Open-to-air strategy PROCEDURE

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.

The experimental group

Traditional closed-wound management PROCEDURE

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.

The control group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Children

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (2)

• 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.

  PMID: 29211657 RESULT

• 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.

  PMID: 23262998 RESULT

MeSH Terms

Conditions

Burns; Wound Infection; Bacterial Infections

Condition Hierarchy (Ancestors)

Wounds and Injuries; Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: November 1, 2020
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)