Efficacy of Negative Pressure Wound Closure Therapy by PICO System in Prevention of Complications of Femoral Artery Exposure
1 other identifier
interventional
250
1 country
1
Brief Summary
Evaluate negative pressure wound closure therapy by PICO system in Prevention of complications of femoral artery exposure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
1 active site
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
Study Start
First participant enrolled
January 31, 2020
CompletedFirst Submitted
Initial submission to the registry
June 21, 2020
CompletedFirst Posted
Study publicly available on registry
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedJuly 1, 2020
June 1, 2020
1 year
June 21, 2020
June 26, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Infection
Clinical( fever, collection) and Radiological
12 months
Hematoma
Blood collected under the suture line
12 months
seroma
Fluid collected under the suture line
12 months
Secondary Outcomes (1)
Wound Dehiscence
12 Months
Study Arms (2)
Application of the device (PICO)
EXPERIMENTALPICO® is a disposable, single-use pump without a canister that generates an effective, non-adjustable, negative pressure of -80 mmHg and that can be used for up to 7 days.(-1113) It incorporates leak detection and low battery indicators and is connected to a 4-layer absorbent dressing that primarily removes wound exudates through evaporative loss. The mechanism of action has been postulated to occur because of the combined effects of a reduction in the frequency of dressing changes, a reduction in stress concentration in the tissue surrounding the incision, and an enhancement in the appositional strength of the incision line, thus reducing dead space and minimizing the risk of wound contamination.(14) PICO® has also been demonstrated to enhance lymphatic clearance and decrease the risk of hematomas or seromas
Conventional Dressing of the femoral wound
NO INTERVENTIONConventional Dressing of the femoral wound
Interventions
Femoral Wound Closure and dressing
Eligibility Criteria
You may qualify if:
- All femoral artery exposure whatever the type of surgery
You may not qualify if:
- who can't give consent (unconscious)
- Those with mental or behavioral disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura
Al Mansurah, Mansoura University, 35111, Egypt
Related Publications (1)
Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
PMID: 41159585DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Block randomization
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2020
First Posted
July 1, 2020
Study Start
January 31, 2020
Primary Completion
January 30, 2021
Study Completion
January 30, 2021
Last Updated
July 1, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share