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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
728
Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation
Application of standard wound dressing post major lower extremity amputation
Beaumont Hospital, Beaumont rd,Dublin 9, D09V2N0
Dublin, Ireland
NOT_YET_RECRUITINGSt Jamess Hospital
Dublin, Ireland
NOT_YET_RECRUITINGSt Vincents University Hospital
Dublin, Ireland
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.
Time frame: 1 month following surgery
Number of days to discharge
Length of time patient is in hospital from date of surgery to date of discharge
Time frame: 6 months following surgery
Rate of re-admission
Number of re-admissions to the hospital from date of surgery
Time frame: 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)
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tallaght University Hospital
Dublin, Ireland
NOT_YET_RECRUITINGUniversity Hospital Galway
Galway, Ireland
RECRUITINGUniversity Hospital Limerick
Limerick, Ireland
NOT_YET_RECRUITINGUniversity Hospital Waterford
Waterford, Ireland
RECRUITINGTime frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 Months following surgery
Rate of Re-operation
Number of re-operations undertaken from date of surgery
Time frame: 1 Month following surgery