Postoperative Abdominal Wounds Clinical Trial
— ISAWOfficial 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.
| Verified date | May 2013 |
| Source | University of Witten/Herdecke |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 12 |
| Est. completion date | June 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | St. Marien-Krankenhaus Ahaus-Vrede | Ahaus | |
| Germany | Asklepios Stadtklinik Bad Tölz GmbH | Bad Tölz | |
| Germany | Bundeswehrkrankenhaus Berlin | Berlin | |
| Germany | Klinikum Bilefeld - Mitte | Bielefeld | |
| Germany | Knappschaftskrankenhaus Bochum der Ruhr | Bochum | |
| Germany | Klinikum Darmstadt, Chirurgische Klinik III | Darmstadt | |
| Germany | Diakonissenkrankenhaus Dessau /Roßlau | Dessau /Roßlau | |
| Germany | Krankenhaus Düren gem. GmbH | Düren | |
| Germany | Klinik für Gefäß- und Endovascular-Chirurgie, Klinikum der Johann Wolfgang Goethe - Universität | Frankfurt am Main | |
| Germany | Krankenhaus Martha-Maria Halle-Dölau | Halle (Saale) | Sachsen-Anhalt |
| Germany | Krankenhaus St. Elisabeth und St. Barbara, Klinik für Allgmein- und Visceralchirurgie | Halle (Saale) | |
| Germany | Universitätsklinikum Halle/Saale, Allgemein-, Viszeral- und Gefäßchirurgie | Halle (Saale) | |
| Germany | Asklepios Westklinikum Hamburg | Hamburg | |
| Germany | Sana Klinikum Hameln-Pyrmont Klinik für Allgemein- und Visceralchirurgie | Hameln | |
| Germany | Gemeinschaftskrankenhaus Herdecke | Herdecke | |
| Germany | Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie | Jena | |
| Germany | Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe, Abt. Gynäkologie | Jena | |
| Germany | Westpfalz-Klinikum GmbH, Klinikum für Allgemein-, Viszeral- und Transplantationschirurgie | Kaiserslautern | |
| Germany | Städtisches Klinikum Karlsruhe gGmbH, Klinik für Allgemein- und Viszeralchirurgie | Karlsruhe | |
| Germany | Kliniken der Stadt Köln Krankenhaus Merheim, Klinik für Visceral-, Gefäß- und Transplantationschirurgie | Köln-Merheim | |
| Germany | Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie | Lübeck | |
| Germany | Klinik und Poliklinik für Allgemein- und Abdominalchirurgie, Johannes Gutenberg- Universität | Mainz | |
| Germany | Wundzentrum München | München | |
| Germany | Klinikum der Universität München, Chirurgische Klinik und Poliklinik | München-Großhadern | |
| Germany | Universitätsklinikum Münster, Klinik für Allgemein und Viszeralchirurgie | Münster | |
| Germany | Städtisches Klinikum Neunkirchen | Neunkirchen/Saar | |
| Germany | Ortenauklinikum Offenburg-Gengenbach | Offenburg | |
| Germany | Klinikum Dorothea Christiane Erxleben | Quedlinburg | |
| Germany | Carl-von-Basedow Klinikum, Saalekreis | Querfurt | |
| Germany | Zentrum für Gefäßmedizin Klinikum Südstadt Rostock | Rostock | |
| Germany | Asklepios Klinikum Uckermark GmbH, Klinik für Allgemein- und Visceralchirurgie | Schwedt | |
| Germany | Agaplesion Bethesda-Krankenhaus Stuttgart | Stuttgart | |
| Germany | HSK Dr. Horst Schmidt Kliniken | Wiesbaden | |
| Germany | Evangelisches Krankenhaus Paul Gerhardt Stift, Allgemein-, Viszeral- und Gefäßchirurgie | Wittenberg |
| Lead Sponsor | Collaborator |
|---|---|
| University of Witten/Herdecke | Kinetic Concepts, Inc., Smith & Nephew Wound Management Inc |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Wound volume | Reduction of wound volume (cubic centimeter) in the course of treatment. | within the observation period of 180 days | No |
| Secondary | Wound infections | Number of wound infections over the time. | within the observation period of 180 days | No |
| Secondary | Recurrences | Number of recurrences over the time. | wthin observation period of 180 days | No |
| Secondary | Pain | within a maximum treatment time of 42 days | No | |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Indirect costs | Disability, disability pension, premature death | within a maximum treatment time of 42 days or until end of therapy | No |
| Secondary | Serious adverse events | within the observation period of 180 days | Yes | |
| Secondary | Adverse events | Wound- and device-specific adverse events | within a maximum treatment time of 42 days | Yes |