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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02118558
Other study ID # 0020-14-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received April 16, 2014
Last updated April 17, 2014
Start date June 2014
Est. completion date January 2017

Study information

Verified date April 2014
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

This trial is a prospective, single center, unblinded, randomized, controlled study to assess the safety and efficacy of negative pressure wound therapy in preventing infections after TKA surgery . The study will enroll 316 patients that will undergo TKA. patients will be randomized to the treatment group and undergo the study intervention - (NPWT) The intervention will take place at the end of the surgery. The Patients that are randomized to the control group will receive standard treatment. Both groups will be assessed at two weeks and six weeks. period.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 0
Est. completion date January 2017
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Ages: 18 to 80

- Males- not involved in active military duty.

- Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.

Exclusion Criteria:

- Active systemic or local infection.

- History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)

- Active autoimmune disease.

- Any past or present immunosuppressive treatment.

- Current treatment with chemotherapeutic agents

- History of metabolic bone disease (primary or secondary).

- Chronic renal insufficiency (defined by 50% increase of normal levels).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Negative Pressure Wound Therapy (NPWT)

Drug:
standard prophylactic therapy
administration of antibiotics before the first incision, keeping the surgery field sterile and performing several rinsing

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks six weeks No
Secondary 1. To assess the proportion on infections at two weeks and 6 weeks of follow-up. To assess the proportion on infections at two weeks and 6 weeks of follow-up. two weeks and six weeks No
Secondary The number of patients recommended to undergo further procedural intervention because of the infection. The number of patients recommended to undergo further procedural intervention because of the infection. 12 MONTHS
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