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Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.
Many factors influence the risk of wound complications. Notably, the presence of unreconstructed proximal occlusive arterial disease is a major influence on stump healing. Patient factors such as smoking, diabetes, obesity, malnutrition and chronic kidney disease are non-modifiable, particularly in the short-term setting. However, surgical factors may be altered in an effort to reduce the risk of wound complications.
One option amenable to alteration is what dressing is applied to the closed incision upon procedure completion. The type of dressing may influence factors such as bacterial access to the wound, the development of collections of blood or fluid in the wound or fluid oozing from the wound. Collectively, these wound factors increase the risk of wound infection. Therefore, dressings which reduce these factors have the potential to reduce wound breakdown, thereby reducing the burden for patients and healthcare systems.
The investigators propose to conduct a multicentre randomised controlled trial comparing prophylactic single-use negative pressure wound therapy with standard dressings in patients with a closed incision following major lower extremity amputation in terms of SSI incidence, wound healing complications and scar appearance, patient quality of life and financial impact on the patient and healthcare system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy. | Experimental | Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation |
|
| Standard Wound dressing | Active Comparator | Application of sterile standard gauze dressing to the wound post major lower extremity amputation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy | Device | Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of wound complications following amputation between NPWT and standard dressings | Infection(deep or superficial), wound dehiscence, partial (fascia intact), complete (fascia breached), seroma, haematoma or stump necrosis. | 1 month following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days to discharge | Length of time patient is in hospital from date of surgery to date of discharge | 6 months following surgery |
| Rate of re-admission | Number of re-admissions to the hospital from date of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stewart Walsh | Contact | 353 915 2422 | stewartredmond.walsh@universityofgalway.ie | |
| Megan Foley | Contact | 353 915 2422 | meganpfoley@rcsi.com |
| Name | Affiliation | Role |
|---|---|---|
| Stewart Walsh, Prof | University Hospital Galway (UHG) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital, Beaumont rd,Dublin 9, D09V2N0 | Not yet recruiting | Dublin | H91 YR71 | Ireland |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D014946 | Wound Infection |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Standard Wound Dressing | Device | Application of standard wound dressing post major lower extremity amputation |
|
| 1 Month following surgery |
| 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 |
| 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 |
| 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 |
| 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 |
| Wound-QoL (Questionnaire on quality of life with chronic wounds) | Wound-QoL (Questionnaire on quality of life with chronic wounds) measures the disease-specific, health-related quality of life of patients with chronic wounds. It can be used in clinical and observational studies as well as in daily practice. The primary endpoint is the reduction of more than 0.4 points in the overall score of the Wound-Qol quality of life questionnaire between D0 and D14. | 1 month following surgery |
| Wound-QoL (Questionnaire on quality of life with chronic wounds) | Wound-QoL (Questionnaire on quality of life with chronic wounds) measures the disease-specific, health-related quality of life of patients with chronic wounds. It can be used in clinical and observational studies as well as in daily practice. The primary endpoint is the reduction of more than 0.4 points in the overall score of the Wound-Qol quality of life questionnaire between D0 and D14. | 3 months following surgery |
| Wound-QoL (Questionnaire on quality of life with chronic wounds) | Wound-QoL (Questionnaire on quality of life with chronic wounds) measures the disease-specific, health-related quality of life of patients with chronic wounds. It can be used in clinical and observational studies as well as in daily practice. The primary endpoint is the reduction of more than 0.4 points in the overall score of the Wound-Qol quality of life questionnaire between D0 and D14. | 6 months following surgery |
| 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 following surgery |
| 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 following surgery |
| 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 following surgery |
| Rate of Re-operation | Number of re-operations undertaken from date of surgery | 1 Month following surgery |
| St Jamess Hospital | Not yet recruiting | Dublin | Ireland |
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| St Vincents University Hospital | Not yet recruiting | Dublin | Ireland |
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| Tallaght University Hospital | Not yet recruiting | Dublin | Ireland |
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| University Hospital Galway | Recruiting | Galway | Ireland |
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| University Hospital Limerick | Not yet recruiting | Limerick | Ireland |
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| University Hospital Waterford | Recruiting | Waterford | Ireland |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |