Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Rate of Surgical Site Infection (SSI) |
To compare the rate of surgical site infections within 1 month of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria. |
1 month following surgery |
|
| Primary |
Rate of Surgical Site Infection (SSI) |
To compare the rate of surgical site infections within 3 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria. |
3 months following surgery |
|
| Primary |
Rate of Surgical Site Infection (SSI) |
To compare the rate of surgical site infections within 6 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria. |
6 months following surgery |
|
| Secondary |
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) |
The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state) |
Baseline |
|
| Secondary |
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) |
The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state) |
1 month following surgery |
|
| Secondary |
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) |
The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state) |
3 months following surgery |
|
| Secondary |
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) |
The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state) |
6 months following surgery |
|
| Secondary |
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) |
The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6 |
1 month following surgery |
|
| Secondary |
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) |
The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6 |
3 months following surgery |
|
| Secondary |
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) |
The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6 |
6 months following surgery |
|
| Secondary |
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) |
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition |
1 month |
|
| Secondary |
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) |
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition |
3 months |
|
| Secondary |
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) |
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition |
6 months |
|
| Secondary |
Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings |
Investigating resource use and cost effectiveness of single-use, prophylactic negative pressure wound therapy versus standard dressings for midline laparotomy wounds based on length of hospital stay and costs of dressings |
6 months |
|
| Secondary |
Healthcare incremental cost- utility ratio |
The incremental cost-effectiveness ratio at 6 months for NPWT vesus standard dressings for patients undergoing laparotomy.The effectiveness will be expressed as quality adjusted life years (QALYs) in a cost-utility analysis. QALYs are a composite measure of outcomes where utilities for health states (on 0-1 scale, where 0 corresponds to death and 1 to full health) act as qualitative weights to combine quantity and quality of life. The number of QALYs in each group will be assessed with the EuroQol 5 Dimensions questionnaire (EQ5D). The EQ-5D measures health status in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression |
6 months |
|
| Secondary |
Healthcare cost-effectiveness ratio at 6 months |
Assessment of the cost-effectiveness ratio at 6 months between NPWT dressings compared to standard dressings. The criteria of effectiveness used will be; Length of hospital stay, requirement for return to theatre, requirement for critical care and number of dressings used |
6 months |
|
