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Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation (NPWTvsGPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02314468
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

Introduction Necrotising soft tissue infections (NSTI) incorporate a spectrum of pathologies, all characterized by an infectious state, typically arising after a penetrating trauma or a surgical procedure and an expeditious spreading of necrosis throughout the soft tissues of the body. It is a rare, life-threatening and devastating infection defined by a necrosis of fascia, subcutaneous tissues and skin. Aggressive surgical debridement to remove all necrotic tissue and define the extent of the disease is still the mainstay of correct treatment of NSTI.

Both negative pressure wound therapy (NPWT) and the application of allograft skin to debrided areas, are documented options for wound bed preparation which are standard in the university hospital of Gent.

NPWT is a technique for wound bed preparation involving the controlled application of sub-atmospheric pressure to the local wound environment, using a sealed wound dressing connected to a vacuum pump. Mechanisms of action attributed to NPWT include an increase in blood flow, promotion of angiogenesis, reduction in wound surface area, positive modulation of the inhibitory contents of wound fluid, induction of cell proliferation, reduction of edema, and bacterial clearance.

Allograft skin or cadaveric skin possesses many of the ideal properties of biologic dressings, and plays a major role in the surgical management of extensive wounds when autologous tissue may not be immediately available. It reduces evaporative water loss and the drainage of protein-rich fluids, prevents wound desiccation, and suppresses microbial proliferation. Wound pain is lessened and the allograft restores a physiologic barrier at the wound surface. Enhancing revascularization, and thereby creating a viable wound bed before final reconstruction, is perceived as one of the most important features of allografting.

Condition or disease Intervention/treatment Phase
Necrotizing Soft Tissue Infection Procedure: Negative pressure wound therapy Procedure: Glycerol Preserved Allografts (GPA) Not Applicable

Detailed Description:

Study objectives This study will compare negative pressure wound therapy versus cadaveric skin as treatment options for wound bed preparation in wounds resulting from necrotising soft tissue infection.

Methodology One arm includes a NPWT system that is used in conjunction with gauze or foam dressings. Dressing changes normally will be carried out twice a week unless otherwise indicated by the wound condition, the patients clinical presentation or a seal broken beyond repair. NPWT wound bed preparation will be ended when two experienced plastic surgeons consider the wound bed suitable for autografting. (Endpoint) The second arm includes application of cadaveric skin. The allografts normally will be changed every seven to ten days or earlier depending on adhesion of the allograft to the wound bed. In practice, the ability of the allograft to adhere to the wound bed has a diagnostic value, referred to as a 'take-test'. If the allograft does not adhere, one must consider an infection or non-viable wound surface. If the allograft adheres to the wound bed and adequate granulation tissue is suspected underneath, then the wound bed is suitable for autografting. (Endpoint)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation in Necrotising Soft Tissue Infections
Study Start Date : October 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: negative pressure wound therapy (NPWT)
negative pressure wound therapy (NPWT)
Procedure: Negative pressure wound therapy
NPWT changed twice a week.

Active Comparator: Glycerol Preserved Allografts (GPA)
Glycerol Preserved Allografts (GPA)
Procedure: Glycerol Preserved Allografts (GPA)
GPA changed every 7 to 10 days.

Primary Outcome Measures :
  1. Quality of wound bed preparation until autografting. [ Time Frame: After 3 days ]
    WHAT software, clinical assessment by plastic surgeon, Laser Doppler Imaging scan.

Secondary Outcome Measures :
  1. Pain assessment until autografting. [ Time Frame: After 3 days ]
    Numerical pain scale.

  2. Ease of use until autografting. [ Time Frame: After 3 days ]
    Numerical scale for ease of use.

  3. Cost utility until autografting. [ Time Frame: After 3 days ]
    Cost of material.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Necrotising soft tissue infection

Exclusion Criteria:

None specific

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02314468

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Contact: Kevin Peters, MD

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University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Kevin Peters, MD   
Principal Investigator: Stan Monstrey, MD, PhD         
Sub-Investigator: Kevin Peters, MD         
Sponsors and Collaborators
University Hospital, Ghent
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Principal Investigator: Stan Monstrey, MD, PhD University Hospital, Ghent
Additional Information:
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Responsible Party: University Hospital, Ghent Identifier: NCT02314468    
Other Study ID Numbers: 2013/724
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Soft Tissue Infections
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs