Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty

NCT01380665 | Withdrawn Phase 4

• 1 other identifier: Prevena2009-45
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.

Conditions

Linear or Emi-linear Incisions; Total Hip Arthroplasty; Total Knee Arthroplasty

Keywords

Prevena; Incision; Management; System; total; knee; hip; replacement; Surgery; Negative; Pressure; dressing; KCI

Outcome Measures

Primary Outcomes (1)

• Negative pressure environment with accurate and reliable indicators;Dressing biocompatible with incision site and skin;Minimal dressing changes during therapy;Acceptable safety profile; minimal/no AEs;Patient comfort and dressing integrity after surgery

  during hospitalization (up to 7 days) and thru follow-up 30 days after dressing removal

Study Arms (1)

There is one group of 100 patients

OTHER

50 of these patients will receive a total hip replacement; 50 patients will receive a total knee replacement;

Device: Prevena Incisional Management System

Interventions

Prevena Incisional Management System DEVICE

All evaluable patients will utilize the Prevena Incisional Management System

There is one group of 100 patients

Eligibility Criteria

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

You may qualify if:

• Subject must be ≥ 18 years of age
• Subject must, at the treating physician's determination and definition, be an appropriate Candidate for primary total hip or knee arthroplasty
• Subjects who undergo primary total knee or hip arthroplasty must have a linear or semi-linear incision whose length and curvature should fit within the dimensions bound by the polyurethane foam (10 inches in length by 2.5 inches in width)
• Subject is able and willing to provide written informed consent and comply with visit schedule
• Subject must agree to avoid application of tanning lotions or exposure of ultraviolet radiation from sun or artificial sources such as a tanning bed on operative area for the duration of study participation
• Subject must not be pregnant if of child-bearing potential, or otherwise must be surgically sterilized or unable to conceive. All females, regardless of child-bearing potential, will receive a urine hCG test 2 weeks prior to surgery and the test result must be negative for pregnancy.
• Subjects who are of child-bearing potential must be utilizing an acceptable method of birth control (eg, birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc) and be willing to continue birth control for duration of study participation. If birth control method is the form of birth control pills, shots, implants skin patches, or IUD, the method must have been utilized for at least 30 days prior to study participation.
• Subject must be willing to wear loose fitting clothing for duration of treatment period
• Subject must be willing to comply with visit schedule for the duration of the study

You may not qualify if:

• Positive pregnancy test confirmed by hCG in urine
• Current or past (30 days prior to surgery) within time of screening attempts to become pregnant
• Current local or systemic infection (eg, skin infections, sinus infections, urinary tract infection, sepsis, etc)
• Current or past (14 days prior to surgery) within time of screening topical treatments on operative area (eg, laser hair or tattoo removal, sunless tanning lotions)
• Current or past (14 days prior to surgery) steroid topical therapies on operative area
• Current or past (30 days prior to surgery) use of oral steroids (NOTE: Use of non-topical, ophthalmic or aerosol types of steroids (ie, inhaled corticosteroids) are permitted at screening and throughout the clinical trial)
• Current or past (72 hours prior to surgery) within surgery use of antihistamines
• Current or past (30 days prior to surgery) within time of screening use of oral Tetracycline or AcutaneTM or topical Tetracycline or AcutaneTM on the operative area
• Presence of skin lesions or abnormalities on operative area
• Current or past malignancy requiring immunosuppressant therapy or chemotherapy within 5 years within time of screening
• Presence of excessive skin folds on operative area
• Intentional exposure of the operative area to ultraviolet radiation (14 days prior to surgery) within time of screening (ie, sunbathing or tanning bed)
• Presence of sunburned or peeling skin on operative area
• Tattoos on operative area
• Presence of severe, raised scar tissue on operative area which may interfere with pre and post skin evaluation assessments

Sponsors & Collaborators

• KCI USA, Inc: lead

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 27, 2011
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 16, 2024

Record last verified: 2024-10