Incision management therapy for patients undergoing a surgery with an applicable surgical incision Surgery
Conditions
Interventions
Control: Negative Pressure Wound Therapy (NPWT) Dressing:
V.A.C.® GRANUFOAM™ with nonadherent interface layer
To be used along with one of the following negative pressu
Sponsors
KCI Medical (Ireland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre-operative inclusion criteria: The particpant: 1. Is able to provide their own informed consent 2. Is =22 years of age Intra-operative inclusion criteria: The particpant: 3. Has a surgically closed incision with a length of less than 20 cm such that the entirety of the incision can be covered by the negative pressure dressing 4. Has a wound that meets CDC Wound Classification 1 or 2 (Clean or Clean-Contaminated)
Exclusion criteria
Exclusion criteria: Pre-operative exclusion criteria: The particpant: 1. Has one or more of the following conditions: 1.1. Uncontrolled diabetes 1.2. BMI greater than 35 1.3. Is currently smoking 2. Has a dehisced surgical wound in the area of the planned incision site 3. Has an oncologic wound in the area of the planned incision site 4. Has an open wound in the area of the planned incision site 5. Has an allergy to acrylic adhesives 6. Is pregnant at the time of study treatment and the planned surgical procedure is an operation other than a Cesarean section (C-section) 7. Is breastfeeding and the planned incision is located on the breast or the area near the breast 8. Is participating in another interventional clinical trial 9. Has signs/symptoms or a documented systemic infection (bacterial, viral or fungal) Intra-operative exclusion criteria: 10. Has a wound that meets CDC Wound Classification 3 or 4 11. Has cellulitis of the incision area 12. Requires use of a nonadherent interface layer containing silver 13. Has inadequate hemostasis of the incision 14. Has ischemia to the incision or incision area 15. Is using V.A.C. VERAFLO™ Therapy (instillation) over the incision site 16. Requires the use of drainage or pain control devices that exit through the surgical incision, or the area covered by the dressing/drape
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of treatment-related adverse events from treatment application, measured using number of events and subject incidence of Treatment Related Adverse Events (TRAE) reported until 30-day follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of surgical site complications (SSC) and surgical site infections from treatment application, measured using occurrence of any SSC reported from treatment start date until 30-day follow-up | — |
Countries
England, United Kingdom
Contacts
Public ContactJens Vydt
Outcome results
None listed