Postoperative Abdominal Wounds, Wound-healing Impairments
Conditions
Keywords
wound healing impairments,, negative pressure wound therapy,, health services research,, germany
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.
Interventions
DEVICENegative Pressure Wound Therapy
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.
Standard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)
Sponsors
Kinetic Concepts, Inc.
Smith & Nephew Wound Management Inc
University of Witten/Herdecke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Wound infections | within the observation period of 180 days | Number of wound infections over the time. |
| Recurrences | wthin observation period of 180 days | Number of recurrences over the time. |
| Pain | within a maximum treatment time of 42 days | — |
| 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. |
| Wound volume | within the observation period of 180 days | Reduction of wound volume (cubic centimeter) in the course of treatment. |
| Indirect costs | within a maximum treatment time of 42 days or until end of therapy | Disability, disability pension, premature death |
| Serious adverse events | within the observation period of 180 days | — |
| Adverse events | within a maximum treatment time of 42 days | Wound- and device-specific adverse events |
| 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 |
Countries
Germany
Outcome results
None listed