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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357287
• Other study ID #: XMRPG3L1721
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: Chang Gung Memorial Hospital
• Contact: Sheng-Hsun Lee
• Phone: +886-3-3281200
• Email: 9002090[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infections
• Periprosthetic Joint Infection
• Surgical Wound
• Wound Heal
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound complication	Wound complication, including: Persistent wound drainage, blisters, hematoma, wound dehiscence, skin necrosis, suture abscess, cellulitis.	12 weeks