RCT on NPWT for Incisions Following Major Lower-limb Amputation to Reduce Surgical Site Infection
Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Incisions Following Major Lower-limb Amputation to Reduce Surgical Site Infection
1 other identifier
interventional
290
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2017
CompletedFirst Posted
Study publicly available on registry
May 9, 2017
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedDecember 8, 2017
December 1, 2017
1.3 years
May 5, 2017
December 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical site infection
Surgical site infection will be defined using the Centre for Disease Control and Prevention Guidelines.
30 days
Secondary Outcomes (4)
Length of stay
30 days
Antibiotic use
30 days
Reoperation
30 days
Death
30 days
Study Arms (2)
Negative pressure wound therapy
EXPERIMENTALA vacuum assisted closure device will be applied in this arm
Standard dressing
OTHERStandard dressing will be applied to this arm
Interventions
Negative pressure wound therapy is a commonly utilized tool in the hospital setting and will be applied to amputations in our study to determine the effect on surgical site infections
A standard dressing will be applied to the amputations in this arm of the study
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Power, MD
London Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
May 5, 2017
First Posted
May 9, 2017
Study Start
March 1, 2018
Primary Completion
July 1, 2019
Study Completion
July 1, 2020
Last Updated
December 8, 2017
Record last verified: 2017-12