Topical Collagen Powder for Healing of Acute Full-thickness Wounds
Wound of Skin, Wound Heal
About this trial
This is an interventional treatment trial for Wound of Skin focused on measuring collagen powder, punch biopsy wound
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- George Washington Medical Faculty Associates
Arms of the Study
Arm 1
Other
Internalized Control
Subjects will receive 2 punch biopsy created wounds, one on each thigh, which will be addressed with primary closure with sutures or will be treated with Nuvagen collagen powder at time of wounding and daily thereafter. Suture(s) will be removed in 2 weeks. At week four, the wounded site will be biopsied again for tissue collection/evaluation, and treated with primary closure again. Suture(s) will be removed within to weeks. For those using collagen powder, the biopsy site will be biopsied again at week 4, and wound care will again be with NuvagenTM collagen powder until closure.