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This is a prospective, open-label, non-randomized interventional feasibility study with a nested qualitative analysis. The study exploratively verifies the feasibility of targeted prophylactic closed incision negative pressure wound therapy (ciNPWT) in clinical practice for patients with a high predicted risk of wound healing complications and compares the 30-day incidence of postoperative complications with standard dressing.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preventive ciNPWT | Experimental |
| |
| Standard dressing | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| closed incision negative pressure wound therapy (ciNPWT) | Device | targeted prophylactic closed incision negative pressure wound therapy in clinical practice for patients with a high predicted risk of wound healing complications |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of targeted prophylactic ciNPWT | Feasibility of prophylactic ciNPWT described as: Recruitment rate (%) | Up to 30 postoperative days |
| Feasibility of targeted prophylactic ciNPWT | Feasibility of prophylactic ciNPWT described as: Completion rate (%) | Up to 30 postoperative days |
| Feasibility of targeted prophylactic ciNPWT | Feasibility of prophylactic ciNPWT described as: Safety and technical complications (description) | Up to 30 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective assessment of wound healing | Objective assessment of wound healing using the ASEPSIS (Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay = ASEPSIS) scoring system (scale 0-100, higher number = worse outcome). | Up to 30 postoperative days. |
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Inclusion Criteria:
Identification as "high-risk" for wound healing complications based on a clinical risk screening at admission.
Signed informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klara Balcarova | Contact | +420731964956 | klara.balcarova@fnhk.cz |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D049291 | Seroma |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Subjective assessment of pain | Pain assessment using the Numeric Rating Scale (NRS, scale 0-10, higher number = worse outcome) at rest and during movement. | Up to 30 postoperative days |
| Subjective assessment of quality of life | Patient-Reported Outcomes including the 5-level version of Quality of life EuroQol Group questionnaire (EQ-5D-5L, scale 5-25, higher number = worse outcome). | Up to 30 postoperative days |
| Subjective treatment satisfaction | Treatment satisfaction and patient experience via an original questionnaire (scale 8-40, higher number = worse outcome). | Up to 30 postoperative days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007249 | Inflammation |
| D006470 | Hemorrhage |