Smith \& Nephew are assessing a new investigational single use NPWT system.
Smith \& Nephew are assessing a new investigational single use NPWT system. There is a significant amount of clinical evidence to show that NPWT may reduce oedema, increase healing and reduce chance of infection, through maintenance of pressure therapy, in closed incisions. Subjects with abdominal incisions and knee incisions following knee surgery will be recruited to the study and receive NPWT for 7 days. The performance of the system will be logged by the device and acceptability of the device will be assessed by patient and clinician. Safety will be assessed with a 30 day follow up to assess complications and device related events.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
90
Investigational single use disposable negative pressure system. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 7 days.
Worthing Hospital
Worthing, West Sussex, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Queen Elizabeth the Queen Mother Hospital
Margate, United Kingdom
Negative Pressure Maintenance at Nominal 80 mmHg
Negative pressure maintenance at nominal 80 mmHg assessed as the average of the negative pressure values recorded by the device for Abdominal and Knee surgery types. This data was summarized to show an average negative pressure provided over the treatment duration.
Time frame: 30 days post-op
Dressing Wear Time
Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type.
Time frame: 7 days
Exudate Management (Occurrence of Exudate Leaks)
Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type.
Time frame: 7 days
Incidence of Surgical Site Infection (SSI)
Number of participants with incidence of Surgical Site Infection (SSI) within 30 days of surgery classified using Centers for Decease Control (CDC) criteria of: * Superficial Infection * Deep Infection * Organ Space Infection * Other
Time frame: 30 days
Incidence of Surgical Site Complications (SSC)
Number of participants with incidence of Surgical Site Complications (SSC) within 30 days of surgery categorized as: * Deep Dehiscence * Superficial Dehiscence * Partial Dehiscence * Total Dehiscence * Seroma * Necrosis * Hematoma * Suture Abscess * Other
Time frame: 30 days
Condition of Peri-Wound Skin Assessed Through Visual Inspection
Condition of peri-wound skin assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other
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North Tyneside General Hospital
North Shields, United Kingdom
RJAH Orthopaedic Hospital
Oswestry, United Kingdom
Peterborough City Hospital
Peterborough, United Kingdom
Torbay Hospital
Torquay, United Kingdom
Time frame: Baseline, 7 days, 14 days, and 30 days
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection
Condition of skin under investigative single use Negative-Pressure Wound Therapy (NPWT) dressing assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other
Time frame: Baseline, 7 days, 14 days, and 30 days
Wound and Skin Visual Analog Scale (VAS) Score Assessment
Wound and Skin VAS score assessment at 7, 14 and 30 days. Scores range from 0 to 100 with a low score associated to a wound with a major gapping, dehiscence, severe inflammation and/or infection (i.e., poor outcome); and a high correspond to a completely healed wound with no evidence for inflammation (i.e., excellent outcome).
Time frame: 7 days, 14 days, and 30 days
Range of Motion Assessment (ROM) for the Knee
Range of Motion (ROM) assessment for the knee at pre-operative visit, post-operative visit, 7, 14 and 30 days.
Time frame: 30 days
Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score
Level of pain during wear by investigational single use Negative-Pressure Wound Therapy (NPWT) Dressing at day 4 and day 7 assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain.
Time frame: 4 days and 7 days
Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score
Level of pain during dressing removal by Abdominal and Knee surgery type at treatment discontinuation (up to day 7) assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain.
Time frame: 7 days