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

NCT05357287 | Unknown

• 1 other identifier: XMRPG3L1721
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Heal; Periprosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• wound complication

  Wound complication, including: Persistent wound drainage, blisters, hematoma, wound dehiscence, skin necrosis, suture abscess, cellulitis.

  12 weeks

Study Arms (1)

Prevena

EXPERIMENTAL

Device: PREVENA incision management system

Interventions

PREVENA incision management system 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.

Prevena

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with periprosthetic joint infection
• indicated for debridement surgery
• 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

You may not qualify if:

• previous flap surgery on the indexed joint
• younger than 18 years of age
• silver allergy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Central Study Contacts

Sheng-Hsun Lee

CONTACT

+886-3-3281200; 9002090@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: March 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-03

Locations

TW (1)