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Topical Collagen Powder for Healing of Acute Full-thickness Wounds

NCT03481907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-03-28

Study results available
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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

Interventions

DEVICE

Nuvagen Collagen Powder

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

Sponsors & Collaborators

  • CPN Biosciences

    collaborator INDUSTRY

  • Adam Friedman

    lead OTHER

Principal Investigators

  • Adam Friedman, MD · GW School of Medicine and Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2018-10-18
Completion
2018-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03481907 on ClinicalTrials.gov