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Product X for Burns

Q: Are there any open slots currently available for this clinical experiment?

<p>According to clinicaltrials.gov, this medical trial has ceased its recruitment of participants, having last been updated on December 1st 2023 since first being posted on January 1 2024. However, there are still 96 other trials recruiting patients at present.</p>

N/A

Waitlist Available

Led By Marc G Jeschke, MD PhD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

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

Must have

<25% total body surface area (TBSA) burn

Autologous donor site(s) on thigh, torso, and/or arm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 months and 6 months post-hospital discharge.

Awards & highlights

Study Summary

This trial tests a new dressing, Product X, to improve wound healing, pain, itch and infection in burn patients requiring skin grafts. Participants will receive either Product X or standard-of-care dressings and data will be collected to compare benefits.

Who is the study for?

This trial is for adults over 18 with deep burns covering less than a quarter of their body, needing skin grafts from their thigh, torso, or arm. It's not for those at the end of life, pregnant women, or active cancer patients under treatment.Check my eligibility

What is being tested?

The study tests Product X against standard dressings (Allevyn and Xeroform) in managing donor sites after skin grafting. Participants are randomly assigned to either Product X or standard care and monitored through photos, daily comfort surveys, and scar assessments.See study design

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include irritation at the donor site dressing area, allergic reactions to materials in Product X compared to standard dressings like Allevyn and Xeroform.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

Less than 25% of my body has been burned.

Select...

I have suitable tissue on my thigh, torso, or arm for donation.

Select...

I am 18 years old or older.

Select...

I have a severe burn that needs surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 months and 6 months post-hospital discharge.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 months and 6 months post-hospital discharge.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months and 6 months post-hospital discharge. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of donor site infections

Number of non-healing donor sites

Poor scarring requiring additional (unplanned) OR measured with the Patient Observer Scar Assessment Score (POSAS).

Secondary outcome measures

Absorption of wound exudate measured daily by the amount of dressing required and the number of additional dressing changes needed.

Donor Site Pain

Itch

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Product XExperimental Treatment1 Intervention

Group II: Standard-of-CareActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,953 Total Patients Enrolled

3 Trials studying Burns

379 Patients Enrolled for Burns

Marc G Jeschke, MD PhDPrincipal InvestigatorHamilton Health Sciences Corporation

4 Previous Clinical Trials

404 Total Patients Enrolled

4 Trials studying Burns

404 Patients Enrolled for Burns

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots currently available for this clinical experiment?

"According to clinicaltrials.gov, this medical trial has ceased its recruitment of participants, having last been updated on December 1st 2023 since first being posted on January 1 2024. However, there are still 96 other trials recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Donor Site Dressing (Product X)

2024. "Novel Donor Site Dressing (Product X)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163742.