Status:
COMPLETED
Topical Collagen Powder for Healing of Acute Full-thickness Wounds
Lead Sponsor:
Adam Friedman
Collaborating Sponsors:
CPN Biosciences
Conditions:
Wound of Skin
Wound Heal
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
We have designed a pilot study to investigate the effect and potential utility of topical NuvagenTM (collagen powder) on the rate and quality of wound healing in healthy volunteers using the punch bio...
Detailed Description
Each patient received a single 4mm punch biopsy on each anterior thigh to provide for internalized controls. One wound was managed with PC, while the other was treated with daily topical collagen powd...
Eligibility Criteria
Inclusion
- Outpatient, male or female subjects of any race, 18-75 years of age
- Able to understand the requirements of the study and understand and sign Informed Consent/HIPAA Authorization forms
- Patients willing to refrain from using topical medications to punch biopsy sites
- Patients who are willing to follow protocol instructions and return for follow-up visits
Exclusion
- Patients that have any medical or skin condition that could impair wound healing
- Patients that have used systemic medications that suppress the immune system within 5 half-lives (if known), or 2 months of enrollment (i.e. corticosteroids)
- Patients that have applied topical steroids to the thigh(s) in the 2 weeks prior to enrollment
- Patients that are currently participating in an investigational study of a drug or device or have participated within 4 weeks of enrollment
- Patients that in the opinion of the investigator demonstrate evidence of unwillingness or inability to follow instructions or to complete the study
- Patients currently using systemic antimicrobials
- Patients with a history of diabetes mellitus
- Patients with a history of bleeding disorders or concomitant treatment with aspirin or anticoagulants (including heparin, low molecular weight heparin, warfarin, fondaparinux, or rivaroxaban)
- Patients with a history of keloids or hypertrophic scars
- Patients with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness)
- Patients with a known allergy or sensitivity to any component of the test medication (including bovine and/or collagen products) or local anesthetic agent used
- Current or previous users of tobacco products
- Recent alcohol or drug abuse is evident
- Pregnant females or nursing mothers. Eligible women of reproductive age will be required to have a negative urine pregnancy test at screening. They will also be required to be on at least 1 reliable form of effective birth control \[examples: barrier method (condoms, diaphragm), oral, injectable, implant birth control or abstinence\] during the course of this study and 30 days following the last treatment period.
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03481907
Start Date
March 15 2018
End Date
November 1 2018
Last Update
March 28 2023
Active Locations (1)
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1
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037