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

Not Applicable

Terminated

• Conditions: Postoperative Abdominal Wounds; Wound-healing Impairments

• Registration Number: NCT01611207
• Lead Sponsor: University of Witten/Herdecke

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.

Study Timeline

• Study First Submitted: 2012-03-28
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-01
• Study First Posted: 2012-06-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-20
• Primary Completion: 2013-12
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound closure	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 Outcome Measures

Name	Time	Method
Recurrences	wthin observation period of 180 days	Number of recurrences over the time.
Quality of Life	within observation period of 180 days	EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 180 days.
Serious adverse events	within the observation period of 180 days
Wound volume	within the observation period of 180 days	Reduction of wound volume (cubic centimeter) in the course of treatment.
Wound infections	within the observation period of 180 days	Number of wound infections over the time.
Direct costs	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
Pain	within a maximum treatment time of 42 days
Indirect costs	within a maximum treatment time of 42 days or until end of therapy	Disability, disability pension, premature death
Adverse events	within a maximum treatment time of 42 days	Wound- and device-specific adverse events

Trial Locations

Locations (34)

Krankenhaus Martha-Maria Halle-Dölau; 🇩🇪 Halle (Saale), Sachsen-Anhalt, 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

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