Infection Clinical Trial
Official title:
Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Incisions Following Major Lower-limb Amputation to Reduce Surgical Site Infection
Surgical site infections following lower extremity amputations have been reported in up to 40% of patients. Surgical site infections have significant morbidity and even mortality in terms of emergency room visits, length of hospital stay, reamputation rates and death. Since its introduction, negative pressure wound therapy has been demonstrated to promote wound healing and possibly decreasing the need for future amputations. The aim of the study is to provide level I evidence for the use of negative pressure wound therapy devices in patients undergoing lower extremity amputation.
Status | Not yet recruiting |
Enrollment | 290 |
Est. completion date | July 2020 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - any patient 18 years or older undergoing amputation of the lower limb, either an above knee amputation (AKA) or below knee amputation (BKA) - ability to read and write English to undergo informed consent Exclusion Criteria: - patients in which a complete seal cannot be obtained at the time of vacuum placement - wounds that are not closed primarily - existing infection - patient is anticipated to not follow-up - inability to read and write English |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
London Health Sciences Centre |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical site infection | Surgical site infection will be defined using the Centre for Disease Control and Prevention Guidelines. | 30 days | |
Secondary | Length of stay | length of hospital stay | 30 days | |
Secondary | Antibiotic use | requirement for antibiotics to treat surgical site infection | 30 days | |
Secondary | Reoperation | requirement for revision of amputation | 30 days | |
Secondary | Death | mortality | 30 days |
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