What side effects are associated with this type of intervention?

Common treatments for burns that aim to reduce scarring, such as silicone gel sheets, corticosteroid creams, and other anti-scarring agents, can have various side effects. Silicone gel sheets are generally well-tolerated but may cause mild skin irritation or maceration. Corticosteroid creams can lead to skin thinning, discoloration, and increased susceptibility to infections with prolonged use. Other anti-scarring agents, like those being studied for Nefopam, may cause local skin reactions such as redness, itching, or irritation. It is important to monitor for these side effects and consult with a healthcare provider for appropriate management.

What prior FDA approvals exist?

The FDA has approved various treatments for burns, focusing primarily on pain management, infection prevention, and wound healing. While specific anti-scarring treatments like Nefopam are still under investigation, other treatments such as silicone gel sheets and corticosteroid injections are commonly used to manage and reduce scarring. Additionally, advanced wound care products like hydrocolloid dressings and bioengineered skin substitutes have been approved to promote healing and minimize scar formation. These treatments aim to improve the overall recovery process for burn patients.

What other types of research exist?

Promising alternatives to Nefopam for burn patients include: 1) Autologous Platelet Concentrates (APC), which have shown potential in improving wound healing and reducing scarring. 2) Low-Level Laser Therapy (LLLT), which has been reported to improve healing and symptoms related to scarring. 3) Hyperbaric Oxygen Therapy (HBO), which has demonstrated some improvement in wound healing, pain, and quality of life in small trials. These therapies are emerging as potential options for enhancing recovery and minimizing scarring in burn patients.

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Nefopam Cream for Burns

Q: What is the mechanism of action of this treatment?

Common treatments for burns, particularly those aimed at preventing or reducing scarring, include topical applications and systemic therapies. Nefopam, for instance, is a pain medication with anti-scarring properties, working by modulating inflammatory responses and promoting proper wound healing. This is crucial for burn patients as it helps prevent the formation of hypertrophic scars and keloids, which can impair movement and cause significant physical and psychological distress. Other treatments, such as silicone gel sheets and corticosteroids, also aim to reduce inflammation and promote organized collagen deposition, further aiding in the prevention of abnormal scar formation.

Phase 2

Recruiting

Led By Edward E Tredget, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Exclusion criteria specific to burn patients in addition to the previously described factors would include severe inhalation injury requiring FiO2 >50%, renal failure requiring dialysis or hemodynamic instability requiring vasopressor therapy at the time of initiation of therapy

Subjects with end stage renal disease, where eGFR </= 30 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hear rate will be measured at day 27, 76, and 104.

Summary

This trial tests a cream called Nefopam to prevent and treat severe scars in adult burn patients. Burn patients often develop difficult-to-treat scars, and Nefopam has shown promise in reducing scar tissue. The cream will be applied to small wounds on the patients' hips, and its effectiveness will be evaluated.

Who is the study for?

Adult burn or trauma patients aged 18-65 with certain types of burns, who can understand and follow study procedures. They must have healthy liver function, no history of abnormal scarring, and not be involved in other healing trials. Women should use birth control and not be pregnant. People with well-managed HIV may join after expert consultation.

What is being tested?

The trial is testing Nefopam Cream's ability to prevent or reduce scarring in burn patients by comparing it to a placebo cream. Patients will receive both treatments on different sides of the hip and undergo regular assessments including photographs, ultrasound for scar thickness, color measurements, and personal scar evaluations.

What are the potential side effects?

While specific side effects are not listed for Nefopam Cream in this context, potential risks could include skin irritation at the application site or allergic reactions if sensitivity to ingredients exists.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe lung damage, kidney failure needing dialysis, or unstable blood pressure needing strong medicine.

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My kidney function is very low (eGFR <= 30 mL/min).

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My BMI is between 15 and 35.

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I have had radiation therapy on the scar that is being studied.

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I have scars, tattoos, or birthmarks near the treatment area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hear rate will be measured at day 27, 76, and 104.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hear rate will be measured at day 27, 76, and 104.

This trial's timeline: 3 weeks for screening, Varies for treatment, and hear rate will be measured at day 27, 76, and 104. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of efficacy by assessing scar/wound healing at day 104 (after completion of Nefopam cream application).

Assessment of efficacy by assessing scar/wound healing at day 13 (during Nefopam cream treatment).

Assessment of efficacy by assessing scar/wound healing at day 20 (during Nefopam cream treatment).

+29 more

Secondary study objectives

Assessment of Safety by assessing drug tolerability.

Assessment of blood pressure.

Assessment of heart rate.

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NefopamExperimental Treatment1 Intervention

NEFOPAM 3% cream will be applied topically to healing deep dermal scratches in the lateral hip of burn patients daily (twice) for 3 weeks during the proliferative phase of wound healing.

Group II: PlaceboPlacebo Group1 Intervention

This will work as a placebo for the experimental drug.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nefopam

2006

Completed Phase 3

~690

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for burns, particularly those aimed at preventing or reducing scarring, include topical applications and systemic therapies. Nefopam, for instance, is a pain medication with anti-scarring properties, working by modulating inflammatory responses and promoting proper wound healing. This is crucial for burn patients as it helps prevent the formation of hypertrophic scars and keloids, which can impair movement and cause significant physical and psychological distress. Other treatments, such as silicone gel sheets and corticosteroids, also aim to reduce inflammation and promote organized collagen deposition, further aiding in the prevention of abnormal scar formation.