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

Comparative Study of Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation in Necrotising Soft Tissue Infections

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.

Study Overview

• Status: Withdrawn
• Conditions: Necrotizing Soft Tissue Infection
• Intervention / Treatment: Procedure: Negative pressure wound therapy; Procedure: Glycerol Preserved Allografts (GPA)

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)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Necrotising soft tissue infection

Exclusion Criteria:

None specific

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: negative pressure wound therapy (NPWT)	Procedure: Negative pressure wound therapy; NPWT changed twice a week.
ACTIVE_COMPARATOR: Glycerol Preserved Allografts (GPA)	Procedure: Glycerol Preserved Allografts (GPA); GPA changed every 7 to 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of wound bed preparation until autografting.	WHAT software, clinical assessment by plastic surgeon, Laser Doppler Imaging scan.	After 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment until autografting.	Numerical pain scale.	After 3 days
Ease of use until autografting.	Numerical scale for ease of use.	After 3 days
Cost utility until autografting.	Cost of material.	After 3 days

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Publications and helpful links

Helpful Links

• website hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2013
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (ESTIMATE): December 11, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Soft Tissue Infections; Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: 2013/724