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

Primary Purpose

Necrotizing Soft Tissue Infection

Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Negative pressure wound therapy
Glycerol Preserved Allografts (GPA)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotizing Soft Tissue Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Necrotising soft tissue infection

Exclusion Criteria:

None specific

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

negative pressure wound therapy (NPWT)

Glycerol Preserved Allografts (GPA)

Arm Description

negative pressure wound therapy (NPWT)

Glycerol Preserved Allografts (GPA)

Outcomes

Primary Outcome Measures

Quality of wound bed preparation until autografting.
WHAT software, clinical assessment by plastic surgeon, Laser Doppler Imaging scan.

Secondary Outcome Measures

Pain assessment until autografting.
Numerical pain scale.
Ease of use until autografting.
Numerical scale for ease of use.
Cost utility until autografting.
Cost of material.

Full Information

First Posted
September 30, 2013
Last Updated
February 7, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT02314468
Brief Title
Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation
Acronym
NPWTvsGPA
Official Title
Comparative Study of Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation in Necrotising Soft Tissue Infections
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
October 2013 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Soft Tissue Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
negative pressure wound therapy (NPWT)
Arm Type
Active Comparator
Arm Description
negative pressure wound therapy (NPWT)
Arm Title
Glycerol Preserved Allografts (GPA)
Arm Type
Active Comparator
Arm Description
Glycerol Preserved Allografts (GPA)
Intervention Type
Procedure
Intervention Name(s)
Negative pressure wound therapy
Intervention Description
NPWT changed twice a week.
Intervention Type
Procedure
Intervention Name(s)
Glycerol Preserved Allografts (GPA)
Intervention Description
GPA changed every 7 to 10 days.
Primary Outcome Measure Information:
Title
Quality of wound bed preparation until autografting.
Description
WHAT software, clinical assessment by plastic surgeon, Laser Doppler Imaging scan.
Time Frame
After 3 days
Secondary Outcome Measure Information:
Title
Pain assessment until autografting.
Description
Numerical pain scale.
Time Frame
After 3 days
Title
Ease of use until autografting.
Description
Numerical scale for ease of use.
Time Frame
After 3 days
Title
Cost utility until autografting.
Description
Cost of material.
Time Frame
After 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Necrotising soft tissue infection Exclusion Criteria: None specific
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Monstrey, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website hospital

Learn more about this trial

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

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