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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05357287

Collaborator

(none)

Enrollment

Location

Arm

33.6

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Heal Periprosthetic Joint Infection	Device: PREVENA incision management system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prevena	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.

Arm

Intervention/Treatment

Experimental: Prevena

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.

Outcome Measures

Primary Outcome Measures

wound complication [12 weeks]
Wound complication, including: Persistent wound drainage, blisters, hematoma, wound dehiscence, skin necrosis, suture abscess, cellulitis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Taoyuan		Taiwan	333

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT05357287

Other Study ID Numbers:

XMRPG3L1721

First Posted:

May 2, 2022

Last Update Posted:

May 2, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Arthritis, Infectious

Wounds and Injuries

Surgical Wound

Study Results

No Results Posted as of May 2, 2022