Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
Condition: Venous Ulcer
MeSH terms: Varicose Ulcer; Ulcer
Study type: Interventional

Summary: 
      This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for
      its ability to naturally (autolytically) remove nonviable tissue and create a healthy
      vascular wound bed. Results will compare venous ulcers treated with Xylos XCell cellulose
      dressing plus standard care to those treated with standard care alone. The hypothesis is that
      XCell will demonstrate more autolytic debridement than the standard of care.
    

Detailed description: 
      Chronic wounds are a problem for both the patient and the health care provider. The
      definition of a chronic wound is one that deviates from the expected sequence of repair in
      time, appearance and response to aggressive treatment. These wounds can be separated into
      distinct classes by etiology, specifically, pressure, ischemic, venous, neuropathic,
      diabetic, inflammatory or infective wounds. The degree of severity can be quite diverse
      spanning the range of superficial epidermal injury to full-thickness skin loss with extensive
      destruction, tissue necrosis, and damage to supporting structures including muscle, tendon,
      and or bone. Treatment of chronic wounds should begin with the management of the underlying
      etiology. For example: In pressure ulcers the elimination or reduction of pressure is the
      primary goal; In venous ulcers, improving venous insufficiency or reducing venous
      hypertension should come first; and in diabetic foot ulceration, proper off loading is
      essential. After treatment of the underlying pathology, one thing that all chronic wounds
      have in common is that they require wound bed preparation in order to stimulate the healing
      process.

      Most clinical wound care trials to evaluate therapeutic agents for wounds have been designed
      to measure healing as the primary endpoint. The sequence of events begins with patient
      examination, wound classification and then the application of the test agent. In most cases,
      the test agent is placed over a wound that is contaminated with excessive bacteria, needs
      debridement, or requires wound bed preparation such as exudate control.

      A new wound dressing (Xylos XCell cellulose wound dressing) is a unique biosynthetic matrix
      material that is hydrophilic and has excellent tensile strength. It has the ability to
      deliver moisture into a wound or absorb moisture. This cellulose matrix is microbially
      derived, biocompatible, pyrogen-free and completely non-toxic. In previous clinical trials
      this dressing displayed the ability to aid the natural process of autolytic wound
      debridement, cleansing and exudate control. From initial observations, it appears that this
      cellulose matrix provides an environment that prepares the wound bed by eliminating nonviable
      tissue, reducing bacterial burden, controlling exudate and exposing healthy granulation
      tissue. With successful wound bed preparation one can now concentrate on healing the chronic
      wound.

      This clinical trial is designed to evaluate the natural cleansing (autolytic debridement
      process) and healing attributes of this new cellulose wound dressing compared to standard of
      care (impregnated gauze). Venous ulcers have been chosen as the model because these wounds
      are often covered with thick fibrous non-viable tissue, are poorly vascularized, are
      contaminated with numerous bacteria and exude copious amount of wound fluid.
    

Intervention name(s): XCell cellulose wound dressing; Impregnated gauze dressing
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wound healing; Venous stasis ulcer; Cellulose dressing; Gauze dressing; Chronic wound