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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS ID 00003498 | Registry Identifier | German Clinical Trials Register |
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The patient recruitment was behind target, no successful completion of the planned patient numbers within trial period could be expected
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| Name | Class |
|---|---|
| Kinetic Concepts, Inc. | INDUSTRY |
| Smith & Nephew Wound Management Inc | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Used therapy systems |
|
| Standard Conventional Wound Therapy | Active Comparator | Standard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 42 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Wound volume | Reduction of wound volume (cubic centimeter) in the course of treatment. | within the observation period of 180 days |
| Wound infections | Number of wound infections over the time. |
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Inclusion Criteria:
Exclusion Criteria:
Lack of infrastructure for outpatient continuation of treatment and study-specific interventions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Martha-Maria Halle-Dölau | Halle | Saxony-Anhalt | 06120 | Germany | ||
| St. Marien-Krankenhaus Ahaus-Vrede |
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|
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| Standard Wound Therapy | Other | Standard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment) |
|
|
| within the observation period of 180 days |
| Recurrences | Number of recurrences over the time. | wthin observation period of 180 days |
| Pain | within a maximum treatment time of 42 days |
| Quality of Life | EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 180 days. | within observation period of 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 | within a maximum treatment time of 42 days or until end of therapy |
| Indirect costs | Disability, disability pension, premature death | within a maximum treatment time of 42 days or until end of therapy |
| Serious adverse events | within the observation period of 180 days |
| Adverse events | Wound- and device-specific adverse events | within a maximum treatment time of 42 days |
| Ahaus |
| 48683 |
| Germany |
| Asklepios Stadtklinik Bad Tölz GmbH | Bad Tölz | 83646 | Germany |
| Bundeswehrkrankenhaus Berlin | Berlin | 10115 | Germany |
| Klinikum Bilefeld - Mitte | Bielefeld | 33604 | Germany |
| Knappschaftskrankenhaus Bochum der Ruhr | Bochum | 44892 | Germany |
| Klinikum Darmstadt, Chirurgische Klinik III | Darmstadt | 64283 | Germany |
| Diakonissenkrankenhaus Dessau /Roßlau | Dessau | 06846 | Germany |
| Krankenhaus Düren gem. GmbH | Düren | 52351 | Germany |
| Klinik für Gefäß- und Endovascular-Chirurgie, Klinikum der Johann Wolfgang Goethe - Universität | Frankfurt am Main | 81377 | Germany |
| Krankenhaus St. Elisabeth und St. Barbara, Klinik für Allgmein- und Visceralchirurgie | Halle | 06110 | Germany |
| Universitätsklinikum Halle/Saale, Allgemein-, Viszeral- und Gefäßchirurgie | Halle | 06120 | Germany |
| Asklepios Westklinikum Hamburg | Hamburg | 22559 | Germany |
| Sana Klinikum Hameln-Pyrmont Klinik für Allgemein- und Visceralchirurgie | Hamelin | 31785 | Germany |
| Gemeinschaftskrankenhaus Herdecke | Herdecke | 58313 | Germany |
| Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie | Jena | 07743 | Germany |
| Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe, Abt. Gynäkologie | Jena | 07743 | Germany |
| Westpfalz-Klinikum GmbH, Klinikum für Allgemein-, Viszeral- und Transplantationschirurgie | Kaiserslautern | 67655 | Germany |
| Städtisches Klinikum Karlsruhe gGmbH, Klinik für Allgemein- und Viszeralchirurgie | Karlsruhe | 76133 | Germany |
| Kliniken der Stadt Köln Krankenhaus Merheim, Klinik für Visceral-, Gefäß- und Transplantationschirurgie | Köln-Merheim | 51109 | Germany |
| Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie | Lübeck | 23538 | Germany |
| Klinik und Poliklinik für Allgemein- und Abdominalchirurgie, Johannes Gutenberg- Universität | Mainz | 55131 | Germany |
| Wundzentrum München | München | 81927 | Germany |
| Klinikum der Universität München, Chirurgische Klinik und Poliklinik | München-Großhadern | 81377 | Germany |
| Universitätsklinikum Münster, Klinik für Allgemein und Viszeralchirurgie | Münster | 48149 | Germany |
| Städtisches Klinikum Neunkirchen | Neunkirchen/Saar | 66538 | Germany |
| Ortenauklinikum Offenburg-Gengenbach | Offenburg | 77654 | Germany |
| Klinikum Dorothea Christiane Erxleben | Quedlinburg | Germany |
| Carl-von-Basedow Klinikum, Saalekreis | Querfurt | 06268 | Germany |
| Zentrum für Gefäßmedizin Klinikum Südstadt Rostock | Rostock | 18059 | Germany |
| Asklepios Klinikum Uckermark GmbH, Klinik für Allgemein- und Visceralchirurgie | Schwedt | 16303 | Germany |
| Agaplesion Bethesda-Krankenhaus Stuttgart | Stuttgart | 70184 | Germany |
| HSK Dr. Horst Schmidt Kliniken | Wiesbaden | 65195 | Germany |
| Evangelisches Krankenhaus Paul Gerhardt Stift, Allgemein-, Viszeral- und Gefäßchirurgie | Wittenberg | 06886 | Germany |
| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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