Wound Surgical, Wound Infection, Cosmesis
Conditions
Keywords
Negative Pressure Wound Therapy, Surgical Site Infection, Post-operative Complications, Health Economics, CoPaQ, WoundQol
Brief summary
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.
Detailed description
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.
Interventions
DEVICENegative Pressure Wound Therapy
Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation
DEVICEStandard Wound Dressing
Application of standard wound dressing post major lower extremity amputation
Sponsors
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years or older; * Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication; * Patients with primary closure of the surgical incision using either interrupted or continuous sutures
Exclusion criteria
* Patients \<18 years; * Women who are pregnant and/or breast-feeding; * Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump; * Patients with amputations where skin glue is the only means of skin closure * Patients with a clinically absent femoral pulse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of wound complications following amputation between NPWT and standard dressings | 1 month following surgery | Infection(deep or superficial), wound dehiscence, partial (fascia intact), complete (fascia breached), seroma, haematoma or stump necrosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-admission | 1 Month following surgery | Number of re-admissions to the hospital from date of surgery |
| Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) | Baseline | 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) |
| Number of days to discharge | 6 months following surgery | Length of time patient is in hospital from date of surgery to date of discharge |
| Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) | 1 Month following surgery | The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition |
| Rate of Re-operation | 1 Month following surgery | Number of re-operations undertaken from date of surgery |
| Wound-QoL (Questionnaire on quality of life with chronic wounds) | 1 month following surgery | 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. |
Countries
Ireland
Contacts
Primary ContactStewart Walsh
Backup ContactMegan Foley
Outcome results
None listed