Clinical Trial: Negative Pressure Wound Therapy With the Engenex™-Pump and Bio-Dome™ Dressing, an Evaluation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Negative Pressure Wound Therapy With the Engenex™-Pump and Bio-Dome™ Dressing, an Evaluation

Brief Summary:

Negative pressure wound therapy (NPWT) has become a powerful tool in wound bed preparation of complex wounds and is routinely used in various disciplines, including general surgery and plastic surgery.

NPWT involves the creation of a controlled subatmospheric pressure in the wound bed. The vacuum is generated by a pump and is distributed over the wound bed by a dressing (mostly a foam or gauze sponge). The therapy has several positive effects on the wound bed, such as improved local blood circulation, stimulation of granulation tissue formation and controlled evacuation of wound exudates. Standard negative pressure applied mostly varies between -120 mmHg and -130 mmHg.A new way of applying NPWT is the Engenex™ system using the Bio-Dome™ Wound Dressing, a specially engineered structure that forms a defined space above the surface of the wound. This space will maintain its size and integrity in the presence of negative pressure and wound fluids and thus effectively imposes strain on the underlying tissue. The material properties of the dressing permit moist wound healing while encouraging efficient removal of exudates. The contact material will not absorb fluid. It has been clinically shown that the Bio-Dome™ Wound Dressing is effective at growing granular tissue in the base of a wound at a safe low negative pressure of -75 mmHg, possibly reducing dressing ingrowth into the wound bed to a minimum.

Our intention is to evaluate NPWT by means of the Engenex™ pump and Bio- Dome™ Wound Dressing in 15 patients. Patients with large soft tissue defects will be examined by a plastic surgeon and if suitable for NPWT they will be treated with the Engenex™ NPWT system.

Before starting NPWT wounds will be evaluated and measured (length, width, depth, vo

Detailed Summary:
Sponsor: University Hospital, Ghent

Current Primary Outcome: To evaluate safety and efficacy of NPWT with Engenex® [ Time Frame: at least 2 weeks ]

Following parameters are assessed:

  • Adverse Events
  • Wound size/volume and clinical aspects (odour, masceration): clinical evaluation, digital photography
  • Degree of pain, measured by a numeric scale and the use of analgesics at each dressing intervention.

  • Control of Bioburden: Rate of critical colonization and/or infection

    •% of patients with clinical infection requiring systemic antimicrobial therapy

  • Monitoring of subject's comfort with the dressing in situ, evaluated by subject.
  • Ease of use and dressing application and dressing removal, evaluated by health care personnel


Original Primary Outcome: Performance of NPWT with Engenex® [ Time Frame: at 3 weeks ]

Wounds are evaluated clinically at baseline and every dressing change. Specimens for microbiological analysis are taken on admission, if possible, the day prior to inclusion, the day of inclusion and at each dressing change.

Pain, comfort and quality of life measurement are scored prior to therapy start and at each dressing change.

After three weeks plastic surgeons will evaluate whether the wound is ready for surgical closure or not.



Current Secondary Outcome: To provide instructions for optimal use of Engenex® [ Time Frame: at least 2 weeks ]

Original Secondary Outcome:

  • Quality of Life [ Time Frame: 3 weeks ]
  • therapy cost analysis [ Time Frame: 3 weeks ]


Information By: University Hospital, Ghent

Dates:
Date Received: April 8, 2010
Date Started: February 2010
Date Completion: December 2015
Last Updated: June 2, 2015
Last Verified: June 2015