Efficacy of Negative Pressure Wound Closure Therapy by PICO System in Prevention of Complications of Femoral Artery Exposure

Evaluate negative pressure wound closure therapy by PICO system in Prevention of complications of femoral artery exposure.

Study Overview

• Status: Unknown
• Conditions: Wound Infection; Wound Surgical
• Intervention / Treatment: Procedure: Femoral Wound Closure and dressing

Detailed Description

INTRODUCTION:

Wound infection is a very common complication in patients who undergo femoral artery exposure. It can lead to prolonged hospital stays, increased healthcare expenditures, admission times, graft failure, and limb loss and is recognized as a significant cause of postoperative morbidity and mortality.

Negative pressure wound therapy (NPWT) has been developped as a method for reducing the risk of wound complications and is the wound dressing of choice in many vascular procedures during the arterial exposure.

The idea of NPWT is a therapeutic technique wherein subatmospheric pressure is applied to a wound using a sealed wound dressing that is connected to a vacuum pump, which can be continuously or intermittently applied.

The mechanism of NPWT, is that it facilitates wound healing by decreasing the bacterial burden; promoting granulation tissue formation, capillary blood flow, endothelial proliferation, and angiogenesis; and restoring the integrity of the capillary basement membrane.

The clinical efficacy of NPWT for closed incisions has been extensively studied in surgical disciplines such as orthopedics, cardiothoracic, and plastic surgery, and its use in promoting wound healing and improving patient outcomes has been validated. The use of vacuum-assisted closure dressings (PICO system) is currently no evidenced that supports the use PICO system of for lower limb femoral incisions. Therefore, we aimed to evaluate the outcomes of PICO system in preventing wound complication in patients with femoral artery exposure.

Aim of the work Evaluate negative pressure wound closure therapy by PICO system in Prevention of complications of femoral artery exposure.

Outcome

Primary outcomes:

Infection Hematoma seroma

Secondary outcomes:

Wound Dehiscence. Patients and methods Study location: The study will be conducted at the department of vascular surgery in Mansoura university hospitals Type of study: Randomized controlled Prospective study Study duration: 2 years: 2019-2021 Sample size: 250 patients n=(Z^2 p(1-p))/d^2 Where: Z= 1.96 at 95% confidence level, P= expected prevalence, d= precision (margin of error)

Study population: The study will be conducted in all patients suspected to femoral artery exposure whatever the type of surgery Inclusion criteria: all patients suspected to femoral artery exposure whatever the type of surgery Exclusion criteria who can't give consent (unconscious)? Those with mental or behavioral disorders will be excluded. Consent: Patients after signing informed consent that possible complication from the procedure ought to happen and what are the alternatives.

Data collection: The demographics, Symptoms and preoperative clinical data will be collected History Data: included patient's demographics, underlying medical conditions, any previous associated morbidity.

Examination: Arterial assessments. Laboratory: Blood picture, Blood sugar level, Kidney functions, Liver functions and Coagulation profile.

Imaging: Duplex US and CTA Method of Randomization: Block randomization: Two elements A for Application of the device, B for conventional dressing A A B B A B A B A B B A B B A A B A B A B A A B Technique After closure of Femoral wound the PICO system is applied for up to 5-7 days. PICO® 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(15) Follow up Every patient will be followed every week till first month, then every 3 months till 1 years.

Hemodynamic improvement was assessed by ankle brachial pressure index (ABI), performed before and after the procedure and every 3 months.

Evaluation made to determine wound complications (Infection, Hematoma, seroma and wound dehiscence)

Statistical analysis The data will be analyzed using Statistical Package for the Social Sciences. The numerical outcomes e.g. age is calculated as mean. Gender will be recorded as frequency and percentage. Chi Square test is applied to assess the association of various parameters. The results will be considered statistically significant if the p-value is found to be less than or equal to 0.05.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura University
    • Mansoura, Mansoura University, Egypt, 35111
      • Recruiting
      • Mansoura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All femoral artery exposure whatever the type of surgery

Exclusion Criteria:

• who can't give consent (unconscious)
• Those with mental or behavioral disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Application of the device (PICO); PICO® 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	Procedure: Femoral Wound Closure and dressing; Femoral Wound Closure and dressing
NO_INTERVENTION: Conventional Dressing of the femoral wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Dehiscence	a wound ruptures along a surgical incision	12 Months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2020
• Primary Completion (ANTICIPATED): January 30, 2021
• Study Completion (ANTICIPATED): January 30, 2021

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Surgical Wound; Wound Infection
• Other Study ID Numbers: RP.19.12.52.R1 - 2020/01/31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No