PluroGel for Burns

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Manitoba, Winnipeg, Canada
Burns
PluroGel - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a topical agent can reduce the amount of tissue removed during a burn debridement.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether PluroGel will improve 1 primary outcome and 3 secondary outcomes in patients with Burns. Measurement will happen over the course of 1-14 days.

1-14 days
Proportion requiring surgery
Relative surface area skin grafted
At each dressing change
Patient and caregiver satisfaction and perception of pain

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Standard dressing
1 of 2
Test dressing
1 of 2
Active Control
Experimental Treatment

This trial requires 25 total participants across 2 different treatment groups

This trial involves 2 different treatments. PluroGel is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Test dressing
Drug
A 0.5 cm layer of PluroGel® followed by the above standard dressing. In addition, this will be covered with moistened gauze, kept moist twice daily. (The additional factors are the use of PluroGel® and moistened gauze. Standard dressing will continue to be used.)
Standard dressing
Drug
Topical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PluroGel
2013
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1-14 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1-14 days for reporting.

Closest Location

University of Manitoba - Winnipeg, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Persons with partial thickness face burns or unilateral limb burn injuries requiring admission.

Patient Q&A Section

Can burns be cured?

"It is possible to induce sustained, symptomatic, healing burn wounds in most patients. Wound complications are not a limiting factor in this approach, as they can be managed safely and effectively. This approach is also inexpensive." - Anonymous Online Contributor

Unverified Answer

What is burns?

"An injury is a traumatic injury. It is defined as a serious injury affecting the skin, the underlying organ or the blood vessels. It is estimated that 1 million people were treated in hospital in the UK in 2007, with 1 in 40 of these needing assistance of some form post-injury. There were over 2,400 cases of hospital-acquired burns, with an admission rate of 674 per 100,000 population. A burn is a injury resulting in damage to body tissue by heat, radiation or chemicals. Burn wounds are often associated with other injuries and may require the use of an ambulance, hospital care and surgery." - Anonymous Online Contributor

Unverified Answer

What causes burns?

"This article aims to provide readers with a quick overview of the physical causes of burns. There is an increasing body of information which suggests that certain environmental factors could increase the risk of burns, including: use of tobacco and alcohol in combination with chemical burn solutions, the use of products containing chemicals, and alcohol or drug-related burns. This article provides suggestions in developing harm-reduction strategies by educating the public on the environmental risk factors for burns and their prevention through effective use of personal protective equipment (in healthcare workers for example)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for burns?

"Treatments for burns include wound care, hyperbaric oxygen treatment, skin grafts, pain control, and antibiotics. Most treatments are aimed at managing infection and maintaining a healthy wound. Surgery is typically reserved for patients who are unable to obtain wound care management through healing. Therapeutic regimens used vary depending on the severity of the fire and the patient.\n" - Anonymous Online Contributor

Unverified Answer

How many people get burns a year in the United States?

"Approximately 750,000 cases of burns were treated in the U.S. in 1997, compared with an incidence of nearly two million burns per year globally. Most adults with burn injuries were male, with most injuries (approximately half of all burns) occurring in the workplace. In adults and children with burns, approximately one million hospital discharges are incurred annually. It is estimated that burn injuries account for 2% of emergency department visits and 15% of hospitalizations. Most burn patients will remain in the hospital for 20 to 28 days, but some will require intensive care. Burn injuries are preventable, and a better understanding of how to prevent burns is needed." - Anonymous Online Contributor

Unverified Answer

What are the signs of burns?

"Signs of burns include skin changes such as blisters and erosions. These may occur in any place on the body, but are more common on the abdomen. The fingers of both hands are commonly involved in the process of self-injury." - Anonymous Online Contributor

Unverified Answer

How does plurogel work?

"This small case series demonstrates that this treatment is effective in the prevention of recurrent corneal erosions(DES) after topical cyclosporine with a concomitant high percentage of patients having a negative baseline Scheimpflug test and lower central flatter iris geometry. While this method appears to be safe and effective, longer follow-up is needed to determine its long-term safety and efficacy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of burns?

"The majority of burn injuries are caused by the following substances: hot water (50%), hot water with detergents (32.5%), liquids (9.3%), alcohol (9.3%), hot objects (4.7%), and gas (3.7%). Prevention efforts regarding the use of child care centers and outdoor activities should be emphasized." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving plurogel?

"There is one trial that looked at the effects of plurogel on burn wounds. This is the only trial that shows a positive result when used on the burn wounds; however, there is no evidence showing it is helpful in treating other conditions." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in plurogel for therapeutic use?

"Plurogel appears to have demonstrated significant clinical efficacy in several studies concerning burn and chemical ointment treatment. Currently, however, its most widely accepted application is the therapy of burns. The use in the therapy of chemical ointment has been demonstrated to be effective." - Anonymous Online Contributor

Unverified Answer

Is plurogel safe for people?

"In patients who do not suffer from a hypersensitivity reaction, PLUs are safe and can be used safely. These data differ slightly from the previously published results in children. The only risk posed to people who are hypersensitive is that small quantities can be injected into the same veins repeatedly leading to intravenous drug administration. This risk is reduced when administering PLUs in combination with lidocaine." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for burns?

"The current review offers evidence-based practice parameters on which clinicians may base their decisions with regard to whether a particular condition is appropriate for participation in clinical trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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