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

2014-08-27 03:14:27 | BioPortfolio


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, volume). Digital photos will be made and wound swabs will be taken for microbiological examination.Dressing changes will be performed twice weekly, on Monday and Thursday or on Tuesday and Friday. At each dressing change a wound will be re-evaluated and measured.

Other parameters to be noted will be, amongst others: pain, comfort, ease of use,material used, time needed for dressing change, etc.

The NPWT treatment will be carried on for maximum three weeks. During this period plastic surgeons will evaluate whether the wound is ready for surgical closure or not.

If surgical closure after 3 weeks is not yet an option possibility exists that NPWT will be continued till max. 4 weeks.

Every wound will be followed up until complete wound healing after surgical closure.

All patients data will be recorded, secured, evaluated and analysed for both medical parameters and health economic parameters.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment




Engenex™ pump and Bio-Dome™ Wound Dressing


University Hospital Ghent




University Hospital, Ghent

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:27-0400

Clinical Trials [1091 Associated Clinical Trials listed on BioPortfolio]

Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from ...

Treatment of Wounds With a New Adhesive Foam Dressing

This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods. Patients will be treated with ELECT for 14 days. Data rela...

Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

The purpose of this study is to see if treating a donor site wound with the ACell dressing is as good as or better than the dressings we currently treat harvested donor sites with. This wi...

Efficacy Study of a New Antimicrobial Wound Dressing to Treat Wounds Caused by Curettage and Electrodesiccation

The purpose of this pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrob...

Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds

The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.

PubMed Articles [2094 Associated PubMed Articles listed on BioPortfolio]

A Self-Pumping Dressing for Draining Excessive Biofluid around Wounds.

Excessive biofluid around wounds often causes infection and hinders wound healing. However, the intrinsic hydrophilicity of the conventional dressing inevitably retains excessive biofluid at the inter...

Venous leg ulcers managed using polyurethane foam with a micropore dressing: two case reports.

Cases of venous leg ulcers (VLU) are expected to rise due to the rapidly ageing population in Malaysia. Central to the management of these wounds is compression therapy together with an appropriate wo...

Use of a gelling fibre dressing in complex surgical or chronic wounds: a case series.

To evaluate the safety and performance of a gelling fibre dressing, with respect to wound exudate management, maceration and periwound skin conditions.

Equivalent outcomes with once versus thrice weekly dressing changes in midline laparotomy wounds treated with negative pressure wound therapy.

While negative pressure wound therapy (NPWT) has been used for decades, there is a paucity of data regarding the appropriate length of time between dressing changes.

Negative pressure wound therapy for open traumatic wounds.

Traumatic wounds (wounds caused by injury) range from abrasions and minor skin incisions or tears, to wounds with extensive tissue damage or loss as well as damage to bone and internal organs. Two key...

Medical and Biotech [MESH] Definitions

The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound. This removes wound exudates, reduces build-up of inflammatory mediators, and increases the flow of nutrients to the wound thus promoting healing.

Head injuries which feature compromise of the skull and dura mater. These may result from gunshot wounds (WOUNDS, GUNSHOT), stab wounds (WOUNDS, STAB), and other forms of trauma.

Penetrating wounds caused by a pointed object.

Wounds caused by objects penetrating the skin.

Removal of degenerated and necrotic epithelium and underlying connective tissue of a periodontal pocket in an effort to convert a chronic ulcerated wound to an acute surgical wound, thereby insuring wound healing and attachment or epithelial adhesion, and shrinkage of the marginal gingiva. The term is sometimes used in connection with smoothing of a root surface or ROOT PLANING. (Jablonski; Illustrated Dictionary of Dentistry, 1982)

More From BioPortfolio on "Negative Pressure Wound Therapy With the Engenex™-Pump and Bio-Dome™ Dressing, an Evaluation"

Quick Search


Relevant Topics

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Searches Linking to this Trial