Topical Collagen Powder for Healing of Acute Full-thickness Wounds

NCT03481907 | Completed Results FDA Device

• 1 other identifier: 26552436
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Wound of Skin; Wound Heal

Keywords

collagen powder; punch biopsy wound

Outcome Measures

Primary Outcomes (1)

• Change in Wound Diameter

  Change in wound diameter will be assessed digitally from photographs of the wounds obtained at several distinct time points, both at the time of wounding and afterwards. The diameter of the biopsy wound is measured to reflect a change from baseline in wound size day 0 and again at week 4.

  4 weeks after first biopsy

Other Outcomes (1)

• Collagen Staining in Histopathology

  at 4 weeks after first biopsy

Study Arms (1)

Internalized Control

OTHER

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.

Device: Nuvagen Collagen Powder

Interventions

Nuvagen Collagen Powder DEVICE

Daily application of Nuvagen collagen powder for 2 to 4 weeks following wounding

Internalized Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Adam Friedman: lead
• CPN Biosciences: collaborator

Study Sites (1)

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

• Qureshi A, Murphy E, Milando R, Rengifo-Pardo M, Clayton C, Friedman A. A Head-to-Head Comparison of Topical Collagen Powder to Primary Closure for Acute Full-Thickness Punch Biopsy-Induced Human Wounds: An Internally Controlled Pilot Study. J Drugs Dermatol. 2019 Jul 1;18(7):667-673.

  PMID: 31334925 DERIVED

Limitations and Caveats

Small sample size, absence of negative control

Results Point of Contact

• Title: Dr. Adam Friedman
• Organization: George Washington University

ajfriedman@mfa.gwu.edu

214 235 7381

Study Officials

• Adam Friedman, MD

  GW School of Medicine and Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a self-controlled trial in which subjects will receive punch biopsies at sites on each leg, and will receive a different treatment on each of the 2 sites.

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 29, 2018
• Study Start: March 15, 2018
• Primary Completion: October 18, 2018
• Study Completion: November 1, 2018
• Last Updated: March 28, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available for public reference after JAN 29 2018
• Access Criteria: Journal of Dermatology and Drugs online access

Locations

US (1)