Evaluate the Efficacy of the Treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) After Surgery by Application of Negative Pressure Wound Therapy (NPWT) in Comparison to Standard Conventional Wound Therapy (SCWT) of the Clinical Routine

Overview

The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic Subcutaneous Abdominal Wound healing-impairments (ISAW).

Full Title of Study: “Randomised Controlled Study to Evaluate the Efficacy of the Treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) After Surgery by Application of Negative Pressure Wound Therapy (NPWT) in Comparison to Standard Conventional Wound Therapy (SCWT) of the Clinical Routine.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2013

Detailed Description

The aim of the study is the comparison between NPWT and Standard Conventional Wound Therapy (SCWT) under clinical, safety and economic aspects in the treatment of postoperative Iatrogenic Subcutaneous Abdominal Wounds (ISAW). The hypothesis is based on the assumption that the application of NPWT for the treatment of postoperative abdominal wound healing impairments (with intact fascia) results in a decrease of time until achievement of wound closure (with confirmation after 30 consecutive days) and for this reason more wound closures can be achieved in the maximum treatment period of 42 days compared to the control therapy.

Interventions

  • Device: Negative Pressure Wound Therapy
    • KCI. V.A.C. Freedom; Acti V.A.C.; INFO V.A.C. to be used with the V.A.C. Granufoam (black), V.A.C. Granufoam Silver and V.A.C. WhiteFoam Smith & Nephew: Renasys GO and Renasys EZ Plus to be used with the Renassys-F/P and Renassys-G Use of the medical devices and applicable consumption items according to manufacturers guidelines and FDA regulations.
  • Other: Standard Wound Therapy
    • Standard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)

Arms, Groups and Cohorts

  • Experimental: Negative Pressure Wound Therapy
    • Used therapy systems
  • Active Comparator: Standard Conventional Wound Therapy
    • Standard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)

Clinical Trial Outcome Measures

Primary Measures

  • Wound closure
    • Time Frame: within 42 days of treatment
    • Time-of-closure (in days) achieved and confirmed wound closures and rate-of-closure (in number). The wound closure is defined as 100% epithelialization; no need for drainage, no need for supportive therapy or a means of assistance and absence of suture material. The closure must remain at least for a period of 30 days.

Secondary Measures

  • Wound volume
    • Time Frame: within the observation period of 180 days
    • Reduction of wound volume (cubic centimeter) in the course of treatment.
  • Wound infections
    • Time Frame: within the observation period of 180 days
    • Number of wound infections over the time.
  • Recurrences
    • Time Frame: wthin observation period of 180 days
    • Number of recurrences over the time.
  • Pain
    • Time Frame: within a maximum treatment time of 42 days
  • Quality of Life
    • Time Frame: within observation period of 180 days
    • EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 180 days.
  • Direct costs
    • Time Frame: within a maximum treatment time of 42 days or until end of therapy
    • direct medical resource use and costs: hospitalization, outpatient contact with study centre and other providers, reimbursable drugs, medical sundries, adjuvants, reimbursable services direct non-medical resource use and costs: services, travel costs, expenditure of time for patients, expenditure of time for lay care
  • Indirect costs
    • Time Frame: within a maximum treatment time of 42 days or until end of therapy
    • Disability, disability pension, premature death
  • Serious adverse events
    • Time Frame: within the observation period of 180 days
  • Adverse events
    • Time Frame: within a maximum treatment time of 42 days
    • Wound- and device-specific adverse events

Participating in This Clinical Trial

Inclusion Criteria

  • Acute subcutaneous abdominal wound-healing impairment after surgical intervention
  • Sizes of wound opening (maximum diameter ≥ 3 cm)
  • Wound surface ≥ 9 qcm

Exclusion Criteria

Lack of infrastructure for outpatient continuation of treatment and study-specific interventions

  • Existence of an open abdominal fascia
  • Acute serious organ failure
  • Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
  • Ongoing / during 3 weeks after chemo therapy
  • Ongoing / during 3 weeks after radiation therapy Contraindications in accordance with the safety precautions issued by the FDA or the companies

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Witten/Herdecke
  • Collaborator
    • Kinetic Concepts, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Marcus Redaèlli, Administative and scientific head of staffed offices of Interdisciplinary Centre for Health Services Research – University of Witten/Herdecke

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