Management of Complex Wounds Using a Constant Tension External Tissue Expander

• Performance of DermaClose system in treatment of complex soft-tissue wounds [ Time Frame: One year ] [ Designated as safety issue: No ]
  Initial and final wound dimensions; secondary soft tissue coverage procedures; dimensions and type of secondary soft tissue coverage procedures required compared to initial wound dimensions; method of wound closure; days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation
  
  

• Superficial wound complications [ Time Frame: One year ] [ Designated as safety issue: No ]
  Superficial wound dehiscence and/or infection not requiring reoperation
  
  
• Pain [ Time Frame: One year ] [ Designated as safety issue: No ]
  Visual Analog Pain Scale (VAS) with DermaClose use, and on study wound at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
  
  
• Quality of Life [ Time Frame: One year ] [ Designated as safety issue: No ]
  Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
  
  
• Cost-to-Benefit ratio of DermaClose use [ Time Frame: One year ] [ Designated as safety issue: No ]
  Costs associated with device use including hospital days, number of procedures, procedural and hospital costs including device, negative pressure wound therapy costs, and operating room time and associated costs
  
  

Upon IRB approval, 50 patients with complex soft tissue wounds, with or without an associated fracture that cannot be closed primarily will have the Dermaclose device applied and will be prospectively followed for 1 year. The Dermaclose device will be applied according to the manufacturer's guidelines. This device may be combined with the use of Negative Pressure Wound Therapy. Primary and secondary end points will be recorded.

Primary end points include:

1. Initial and final wound dimensions
2. Secondary soft tissue coverage procedures
3. Dimensions and type of secondary soft tissue coverage procedures required compared to initial wound dimensions
4. Method of wound closure
5. Days to wound closure
6. Number and types of procedures required for wound closure
7. Infection requiring reoperation
8. Wound dehiscence requiring reoperation

Secondary end points include:

1. Superficial wound dehiscence not requiring reoperation
2. Superficial wound infection not requiring reoperation
3. Visual Analog Pain Scale (VAS) with Dermaclose use
4. Use of negative pressure wound therapy
5. Cost-to-benefit ratio of Dermaclose use - hospital days, number of procedures, procedural and hospital costs including device, negative pressure wound therapy costs, and operating room time and associated costs

Patients will be evaluated daily during their inpatient hospital stays for VAS related to the wound for which the Dermaclose device is used. If the Dermaclose device is used on an outpatient basis, the patient will be asked to complete a daily VAS at the same time to monitor pain associated with device use. After hospital discharge, the patients will be evaluated at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. They will complete an SF-12 as part of the above evaluations. Patients may be evaluated at more frequent intervals if the need arises. Primary and secondary endpoints will be evaluated at each time point.