CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 294 enrolled
Drug / intervention
Closed Incision Negative Pressure Therapy (ciNPT) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03274466
NCT03274466N/ACompleted
CompareCT.gov

Post-market, Randomized, Open-Label, Multicenter, Study to Evaluate the Effectiveness of Closed Incision Negative Pressure Therapy Versus Standard of Care Dressings in Reducing Surgical Site Complications in Subjects With Revision of a Failed Total Knee Arthroplasty (PROMISES)

KCI USA, Inc·interventional·Posted Sep 7, 2017·Updated Oct 16, 2024

In Brief

A clinical study evaluating Closed Incision Negative Pressure Therapy (ciNPT) and Standard of Care Dressing for Surgical Wound and 8 related conditions. Completed, enrolled 294 participants across 17 sites.

Detailed Summary

This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease, Musculoskeletal Disease, Prosthesis-Related Infections, Infection, Postoperative Complications, Pathologic Processes
CountriesUnited States
Collaborators3M

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 7, 2017
Enrollment StartDec 5, 2017
Primary CompletionNov 27, 2019
Study CompletionDec 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.8 years ago

Interventions

Closed Incision Negative Pressure Therapy (ciNPT)device

Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.

Standard of Care Dressingdevice

A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.