NCT03481907

Topical Collagen Powder for Healing of Acute Full-thickness Wounds

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Adam Friedman · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wound of Skin
• Wound Heal

Interventions

Type	Name	Description
DEVICE	Nuvagen Collagen Powder	Daily application of Nuvagen collagen powder for 2 to 4 weeks following wounding

Timeline

• Start date: 2018-03-15
• Primary completion: 2018-10-18
• Completion: 2018-11-01
• First posted: 2018-03-29
• Last updated: 2023-03-28
• Results posted: 2023-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study