Topical Collagen Powder for Healing of Acute Full-thickness Wounds

Completed · Not applicable

Conditions studied: Wound of Skin, Wound Heal

In brief

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 biopsy method. After inducing an acute full-thickness wound, the rate of complete healing of a wound treated with topical NuvagenTM (collagen powder) will be compared to the rate of complete healing of a wound treated with primary closure with sutures, the current gold standard. Qualification and semi-quantification of histologic and immunohistochemical markers will be used to assess the maturity and structural stability of the wound bed. Positive findings would suggest that NuvagenTM (collagen powder) may be capable of stimulating the healing of acute wounds in a similar or even superior manner to primary closure, suggesting collagen powder may be used in place of sutures, and encouraging further studies to characterize its therapeutic potential in dermatologic surgery.

Key facts

Study ID

NCT03481907

Run by

Adam Friedman

People needed

8

Starts

2018-03-15

Expected to finish

2018-11-01

Last updated by the study team

2023-03-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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