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

NCT02314468 | Withdrawn

• 1 other identifier: 2013/724
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Soft Tissue Infection

Outcome Measures

Primary Outcomes (1)

• Quality of wound bed preparation until autografting.

  WHAT software, clinical assessment by plastic surgeon, Laser Doppler Imaging scan.

  After 3 days

Secondary Outcomes (3)

• Pain assessment until autografting.

  After 3 days

• Ease of use until autografting.

  After 3 days

• Cost utility until autografting.

  After 3 days

Study Arms (2)

negative pressure wound therapy (NPWT)

ACTIVE COMPARATOR

negative pressure wound therapy (NPWT)

Procedure: Negative pressure wound therapy

Glycerol Preserved Allografts (GPA)

ACTIVE COMPARATOR

Glycerol Preserved Allografts (GPA)

Procedure: Glycerol Preserved Allografts (GPA)

Interventions

Negative pressure wound therapy PROCEDURE

NPWT changed twice a week.

negative pressure wound therapy (NPWT)

Glycerol Preserved Allografts (GPA) PROCEDURE

GPA changed every 7 to 10 days.

Glycerol Preserved Allografts (GPA)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Necrotising soft tissue infection

You may not qualify if:

• None specific

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• website hospital

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Stan Monstrey, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: December 11, 2014
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

BE (1)