Closed Incisional Negative Pressure Wound Therapy in Post-surgical Wound Care of Patients With Periprosthetic Joint Infection

NCT ID: NCT05357287

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2024-12-31

Brief Summary

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In the proposed study, we will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement.

Most periprosthetic joint infections are from hematogenous origin. Hence, it is considered clean wound unless there is a discharging sinus.

Detailed Description

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Conditions

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Wound Heal Periprosthetic Joint Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prevena

Group Type EXPERIMENTAL

PREVENA incision management system

Intervention Type DEVICE

We will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement.

Interventions

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PREVENA incision management system

We will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. patients with periprosthetic joint infection
2. indicated for debridement surgery
3. high risk for wound complication, including one of the followings: diabetes mellitus, use anticoagulants other than aspirin, current smoker, on immunomodulators or steroids, malnutrition, liver disease, renal failure, BMI \> 35 kg/m2

Exclusion Criteria

1. previous flap surgery on the indexed joint
2. younger than 18 years of age
3. silver allergy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Hsun Lee

Role: CONTACT

+886-3-3281200 ext. 2420

Facility Contacts

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Sheng-Hsun Lee

Role: primary

+886-3-3281200 ext. 2420

Other Identifiers

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XMRPG3L1721

Identifier Type: -

Identifier Source: org_study_id

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