Topical Collagen Powder for Healing of Acute Full-thickness Wounds
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/16/2018 |
| Start Date: | March 15, 2018 |
| End Date: | November 1, 2018 |
Topical Collagen Powder as a Wound Healing Adjuvant for Acute Full-thickness Punch Biopsy-induced Human Wounds: a Pilot Study
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.
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.
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.
We found this trial at
1
site
Washington, District of Columbia 20037
Principal Investigator: Adam J. Friedman, MD
Phone: 202-741-3547
Click here to add this to my saved trials
