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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 (ISAW)

Primary Purpose

Postoperative Abdominal Wounds, Wound-healing Impairments

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Standard Wound Therapy
Sponsored by
University of Witten/Herdecke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Abdominal Wounds focused on measuring wound healing impairments,, negative pressure wound therapy,, health services research,, germany

Eligibility Criteria

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

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

Sites / Locations

  • Krankenhaus Martha-Maria Halle-Dölau
  • St. Marien-Krankenhaus Ahaus-Vrede
  • Asklepios Stadtklinik Bad Tölz GmbH
  • Bundeswehrkrankenhaus Berlin
  • Klinikum Bilefeld - Mitte
  • Knappschaftskrankenhaus Bochum der Ruhr
  • Klinikum Darmstadt, Chirurgische Klinik III
  • Diakonissenkrankenhaus Dessau /Roßlau
  • Krankenhaus Düren gem. GmbH
  • Klinik für Gefäß- und Endovascular-Chirurgie, Klinikum der Johann Wolfgang Goethe - Universität
  • Krankenhaus St. Elisabeth und St. Barbara, Klinik für Allgmein- und Visceralchirurgie
  • Universitätsklinikum Halle/Saale, Allgemein-, Viszeral- und Gefäßchirurgie
  • Asklepios Westklinikum Hamburg
  • Sana Klinikum Hameln-Pyrmont Klinik für Allgemein- und Visceralchirurgie
  • Gemeinschaftskrankenhaus Herdecke
  • Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
  • Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe, Abt. Gynäkologie
  • Westpfalz-Klinikum GmbH, Klinikum für Allgemein-, Viszeral- und Transplantationschirurgie
  • Städtisches Klinikum Karlsruhe gGmbH, Klinik für Allgemein- und Viszeralchirurgie
  • Kliniken der Stadt Köln Krankenhaus Merheim, Klinik für Visceral-, Gefäß- und Transplantationschirurgie
  • Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie
  • Klinik und Poliklinik für Allgemein- und Abdominalchirurgie, Johannes Gutenberg- Universität
  • Klinikum der Universität München, Chirurgische Klinik und Poliklinik
  • Wundzentrum München
  • Universitätsklinikum Münster, Klinik für Allgemein und Viszeralchirurgie
  • Städtisches Klinikum Neunkirchen
  • Ortenauklinikum Offenburg-Gengenbach
  • Klinikum Dorothea Christiane Erxleben
  • Carl-von-Basedow Klinikum, Saalekreis
  • Zentrum für Gefäßmedizin Klinikum Südstadt Rostock
  • Asklepios Klinikum Uckermark GmbH, Klinik für Allgemein- und Visceralchirurgie
  • Agaplesion Bethesda-Krankenhaus Stuttgart
  • HSK Dr. Horst Schmidt Kliniken
  • Evangelisches Krankenhaus Paul Gerhardt Stift, Allgemein-, Viszeral- und Gefäßchirurgie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative Pressure Wound Therapy

Standard Conventional Wound Therapy

Arm Description

Used therapy systems

Standard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)

Outcomes

Primary Outcome Measures

Wound closure
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 Outcome Measures

Wound volume
Reduction of wound volume (cubic centimeter) in the course of treatment.
Wound infections
Number of wound infections over the time.
Recurrences
Number of recurrences over the time.
Pain
Quality of Life
EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 180 days.
Direct costs
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
Disability, disability pension, premature death
Serious adverse events
Adverse events
Wound- and device-specific adverse events

Full Information

First Posted
March 28, 2012
Last Updated
May 17, 2013
Sponsor
University of Witten/Herdecke
Collaborators
Kinetic Concepts, Inc., Smith & Nephew Wound Management Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01611207
Brief Title
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
Acronym
ISAW
Official Title
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
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
The patient recruitment was behind target, no successful completion of the planned patient numbers within trial period could be expected
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witten/Herdecke
Collaborators
Kinetic Concepts, Inc., Smith & Nephew Wound Management Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Abdominal Wounds, Wound-healing Impairments
Keywords
wound healing impairments,, negative pressure wound therapy,, health services research,, germany

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
Used therapy systems
Arm Title
Standard Conventional Wound Therapy
Arm Type
Active Comparator
Arm Description
Standard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy
Other Intervention Name(s)
Vacuum assisted closure, Vacuum assisted wound closure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Wound Therapy
Other Intervention Name(s)
Standard Conventional Wound Therapy
Intervention Description
Standard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)
Primary Outcome Measure Information:
Title
Wound closure
Description
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.
Time Frame
within 42 days of treatment
Secondary Outcome Measure Information:
Title
Wound volume
Description
Reduction of wound volume (cubic centimeter) in the course of treatment.
Time Frame
within the observation period of 180 days
Title
Wound infections
Description
Number of wound infections over the time.
Time Frame
within the observation period of 180 days
Title
Recurrences
Description
Number of recurrences over the time.
Time Frame
wthin observation period of 180 days
Title
Pain
Time Frame
within a maximum treatment time of 42 days
Title
Quality of Life
Description
EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 180 days.
Time Frame
within observation period of 180 days
Title
Direct costs
Description
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
Time Frame
within a maximum treatment time of 42 days or until end of therapy
Title
Indirect costs
Description
Disability, disability pension, premature death
Time Frame
within a maximum treatment time of 42 days or until end of therapy
Title
Serious adverse events
Time Frame
within the observation period of 180 days
Title
Adverse events
Description
Wound- and device-specific adverse events
Time Frame
within a maximum treatment time of 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Krankenhaus Martha-Maria Halle-Dölau
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
St. Marien-Krankenhaus Ahaus-Vrede
City
Ahaus
ZIP/Postal Code
48683
Country
Germany
Facility Name
Asklepios Stadtklinik Bad Tölz GmbH
City
Bad Tölz
ZIP/Postal Code
83646
Country
Germany
Facility Name
Bundeswehrkrankenhaus Berlin
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
Klinikum Bilefeld - Mitte
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Knappschaftskrankenhaus Bochum der Ruhr
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Klinikum Darmstadt, Chirurgische Klinik III
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Diakonissenkrankenhaus Dessau /Roßlau
City
Dessau /Roßlau
ZIP/Postal Code
06846
Country
Germany
Facility Name
Krankenhaus Düren gem. GmbH
City
Düren
ZIP/Postal Code
52351
Country
Germany
Facility Name
Klinik für Gefäß- und Endovascular-Chirurgie, Klinikum der Johann Wolfgang Goethe - Universität
City
Frankfurt am Main
ZIP/Postal Code
81377
Country
Germany
Facility Name
Krankenhaus St. Elisabeth und St. Barbara, Klinik für Allgmein- und Visceralchirurgie
City
Halle (Saale)
ZIP/Postal Code
06110
Country
Germany
Facility Name
Universitätsklinikum Halle/Saale, Allgemein-, Viszeral- und Gefäßchirurgie
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Sana Klinikum Hameln-Pyrmont Klinik für Allgemein- und Visceralchirurgie
City
Hameln
ZIP/Postal Code
31785
Country
Germany
Facility Name
Gemeinschaftskrankenhaus Herdecke
City
Herdecke
ZIP/Postal Code
58313
Country
Germany
Facility Name
Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe, Abt. Gynäkologie
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH, Klinikum für Allgemein-, Viszeral- und Transplantationschirurgie
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe gGmbH, Klinik für Allgemein- und Viszeralchirurgie
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Kliniken der Stadt Köln Krankenhaus Merheim, Klinik für Visceral-, Gefäß- und Transplantationschirurgie
City
Köln-Merheim
ZIP/Postal Code
51109
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinik und Poliklinik für Allgemein- und Abdominalchirurgie, Johannes Gutenberg- Universität
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum der Universität München, Chirurgische Klinik und Poliklinik
City
München-Großhadern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Wundzentrum München
City
München
ZIP/Postal Code
81927
Country
Germany
Facility Name
Universitätsklinikum Münster, Klinik für Allgemein und Viszeralchirurgie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Städtisches Klinikum Neunkirchen
City
Neunkirchen/Saar
ZIP/Postal Code
66538
Country
Germany
Facility Name
Ortenauklinikum Offenburg-Gengenbach
City
Offenburg
ZIP/Postal Code
77654
Country
Germany
Facility Name
Klinikum Dorothea Christiane Erxleben
City
Quedlinburg
Country
Germany
Facility Name
Carl-von-Basedow Klinikum, Saalekreis
City
Querfurt
ZIP/Postal Code
06268
Country
Germany
Facility Name
Zentrum für Gefäßmedizin Klinikum Südstadt Rostock
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Asklepios Klinikum Uckermark GmbH, Klinik für Allgemein- und Visceralchirurgie
City
Schwedt
ZIP/Postal Code
16303
Country
Germany
Facility Name
Agaplesion Bethesda-Krankenhaus Stuttgart
City
Stuttgart
ZIP/Postal Code
70184
Country
Germany
Facility Name
HSK Dr. Horst Schmidt Kliniken
City
Wiesbaden
ZIP/Postal Code
65195
Country
Germany
Facility Name
Evangelisches Krankenhaus Paul Gerhardt Stift, Allgemein-, Viszeral- und Gefäßchirurgie
City
Wittenberg
ZIP/Postal Code
06886
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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