Topical Collagen Powder for Healing of Acute Full-thickness Wounds
Condition: Wound of Skin; Wound Heal
MeSH terms: Wounds and Injuries
Study type: Interventional

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.
    

Intervention name(s): Nuvagen Collagen Powder
Intervention type(s): Device
Intervention description(s): Daily application of Nuvagen collagen powder for 2 to 4 weeks following wounding
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: collagen powder; punch biopsy wound