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Topical Collagen Powder for Healing of Acute Full-thickness Wounds

Primary Purpose

Wound of Skin, Wound Heal

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nuvagen Collagen Powder

About this trial

This is an interventional treatment trial for Wound of Skin focused on measuring collagen powder, punch biopsy wound

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Other

Arm Label

Internalized Control

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03481907

First Posted

March 15, 2018

Last Updated

March 27, 2023

Sponsor

Adam Friedman

Collaborators

CPN Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT03481907

Brief Title

Topical Collagen Powder for Healing of Acute Full-thickness Wounds

Official Title

Topical Collagen Powder as a Wound Healing Adjuvant for Acute Full-thickness Punch Biopsy-induced Human Wounds: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

March 15, 2018 (Actual)

Primary Completion Date

October 18, 2018 (Actual)

Study Completion Date

November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Adam Friedman

Collaborators

CPN Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

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 powder for up to four weeks. Prior to each biopsy, the areas were cleansed with an alcohol swab and anesthetized using 1 mL of 2% lidocaine with epinephrine. An Integra Miltex 4.0 mm Standard Biopsy Punch instrument was used to create full-thickness wounds and pressure was applied with gauze until hemostasis occurred. Up to one gram of topical type 1, 100% bovine collagen powder (NuvagenTM, CPN Biosciences, Inc., Largo, FL) was placed on one wound before covering it with a non-adherent sterile dressing. The other wound underwent PC with two epidermal sutures (Ethilon Nylon Sutures, Ethicon, Somerville, NJ) and was similarly covered with a sterile dressing. At the four week follow-up, wounds were re-biopsied following the same procedures. For home treatment, patients were provided with collagen powder in one-gram containers and dressings along with the following instructions: 1) Irrigate the wound with tap water or saline solution, 2) Dry the wound with gently with dry gauze, 3) Apply up to one gram of collagen powder to the wound, and 4) Apply a sterile dressing. Assistance from a caregiver was permitted as needed. This procedure was repeated daily for four weeks after the first biopsy and until wound closure after the second biopsy. For wounds closed primarily, patients were instructed to apply petroleum jelly before covering the wounds with sterile dressings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound of Skin, Wound Heal

Keywords

collagen powder, punch biopsy wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internalized Control

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Nuvagen Collagen Powder

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Wound Diameter

Description

Time Frame

4 weeks after first biopsy

Other Pre-specified Outcome Measures:

Title

Collagen Staining in Histopathology

Description

histopathological processing was performed by HistoWiz, Inc. (Brooklyn, NY) on one baseline sample and both four-week samples, including hematoxylin and eosin (H&E), CD31 (platelet-derived endothelial cell adhesion molecule-1), and Masson trichrome staining. H&E staining was used to examine the quality of the epidermis and colla- gen bundles as well as to observe the amount of inflammatory granulation tissue.

Time Frame

at 4 weeks after first biopsy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Friedman, MD

Organizational Affiliation

GW School of Medicine and Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

George Washington Medical Faculty Associates

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The results are published in Journal of Dermatology and Drugs

IPD Sharing Time Frame

The data will be available for public reference after JAN 29 2018

IPD Sharing Access Criteria

Journal of Dermatology and Drugs online access

IPD Sharing URL

https://pubmed.ncbi.nlm.nih.gov/31334925/

Citations:

PubMed Identifier

31334925

Citation

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.

Results Reference

derived

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Topical Collagen Powder for Healing of Acute Full-thickness Wounds

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