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 Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Postoperative Abdominal Wounds, Wound-healing Impairments

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy
* Other: Standard Wound Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative Pressure Wound Therapy<br>Used therapy systems | Device: Negative Pressure Wound Therapy<br>* 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.<br>* Other names: Vacuum assisted wound closure;|
| Active Comparator: Standard Conventional Wound Therapy<br>Standard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment) | Other: Standard Wound Therapy<br>* Standard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)<br>* Other names: Standard Conventional Wound Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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germany, wound healing impairments,, negative pressure wound therapy,, health services research,