Postoperative Surgical Site Infection Clinical Trial
Official title:
Prophylactic Use of a Negative Pressure Incision Management System in Infrainguinal Vascular Surgery - A Multicentre Randomized Controlled Trial
Verified date | March 2022 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Negative pressure wound therapy (NPWT) has been used in treating postoperative SSI with encouraging results and is now an accepted element in the arsenal of tools for treating these complications. The concept of applying NPWT to closed surgical wounds as a preventive measure is relatively new but draws on the inherent properties of the method which could theoretically lead to reduced seroma formation, wound dehiscence, increased capillary circulation and consequently better wound healing and fewer SSI. Given the incidence and the consequences of SSI in infrainguinal vascular procedures any appreciable decrease in the burden of these complications could have profound benefits for patients and healthcare facilities. As to date, there are no published data from randomized controlled trials investigating the effectiveness of this prophylactic measure. The aim of this study is to assess the effect of NPWT applied to closed surgical wounds directly after skin closure compared to standard sterile gauze dressing in reducing the incidence and severity of postoperative SSI in infrainguinal surgical wounds in patients undergoing elective, open vascular surgery.
Status | Recruiting |
Enrollment | 118 |
Est. completion date | March 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Patients older than 18 years. 2. The clinical criterion for study entry is elective: a. Open infrainguinal vascular surgery for peripheral arterial disease i. Thrombendarterectomy (TEA) ii. Bypass surgery with vein or synthetic graft 3. Patients on whom complete seal of NPWT can be maintained during the first 24 hours after operation. - Exclusion Criteria: 1. All emergency cases. 2. Infrainguinal endovascular procedures. 3. Pre-existing groin infections. 4. Sensitivity/allergy to materials used in NPWT dressing. 5. Patients on whom an adequate and complete seal of NPWT dressing cannot be obtained. 6. Unwillingness to participate. - |
Country | Name | City | State |
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Sweden | Karolinska university Hospital | Stockholm |
Lead Sponsor | Collaborator |
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Karolinska University Hospital | Stockholm South General Hospital |
Sweden,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative surgical site infection (SSI) within 30 days. | SSI classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythema, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and inpatient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent. | 30 days | |
Secondary | Postoperative SSI within 90 days | SSI classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythmea, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and inpatient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent. | 90 days | |
Secondary | Antibiotic prescriptions for skin and soft tissue infections within 90 days postoperatively. | 90 days | ||
Secondary | Postoperative SSI within 90 days requiring surgical revision. | 90 days | ||
Secondary | Adverse events directly related the NPWT dressing leading discontinuation of treatment. | Death due to procedural complications Vascular complications Severe or life-threatening bleeding Limb loss TIA/stroke or myocardial infarction Allergic skin reactions Device related skin damage e.g. abrasions, blisters or wounds |
7 dats | |
Secondary | Major lower limb amputation and/or mortality within 90 days postoperatively. | 90 days | ||
Secondary | Changes in reported quality of life during the 30 day postoperative period. | Changes in QoL assessment questionnaires (SF-36 and EQ-5D) preoperatively and 30 days postoperative. | 30 days | |
Secondary | Assessment of healthcare related costs within 30 days postoperatively. | 30 days | ||
Secondary | Assessment of quality of life during the first seven day period after operation | The Wound QoL questionnaire will help assess QoL during the period that the NPWT device (Prevena) will be used in patients randomized to the experimental group. | 7 days |