Missing Methodology: The Lack of RCTs on NPWTi-d

Paul Kim, DPM, MS, discusses the near absence of randomized control trials (RCTs) exploring negative pressure wound therapy with instillation and dwell time (NPWTi-d) in wound care. 

Access the study Dr. Kim mentions, here.

Transcript:

Paul Kim:  [0:03] Now, there's one prospective randomized multicenter study that was published last year which I was the PI on, involve multiple academic institutions including Georgetown, UT Southwestern Brigham and Women's and University of Miami.

[0:19] And that study concluded. It was a large, robust study over 90 patients in each arm, comparative...It was a comparative randomized study comparing negative-pressure wound therapy versus that of negative pressure wound therapy with instillation.

[0:34] The final result of that is what we had suspected all along. And by the way, that's published and out in the literature for everyone to review.

[0:42] Well, one of the results that I think is the most important result, is it clearly demonstrated a decrease in bacterial count between the two groups, the instillation group versus the standard negative-pressure group. And that's an important piece because I think that's largely how the mechanism of action works with instillation therapy.

[1:04] Now, there were some flaws to that study. Now, going back as I look at the design, perhaps it should have been designed a little bit more carefully. Because one of the things that we did was allowed the surgeons to make a decision on the, the number of times the patient needed to go to the operating room.

[1:19] And as you know, every surgeon is different in their approach and their availability to the operating room is, is varied. And we didn't really take that into account.

[1:27] We expected people to use a pretty straightforward algorithm that we had employed, that I had employed prior in my time at Georgetown before I came here to UT Southwestern. And that's simply not how people operate in the real world.

[1:40] And so there was a discrepancy as far as meeting the primary endpoint. It wasn't a realistic one. But again, the most important and clinical aspect of clinical findings from that study is the fact that we clearly demonstrated a decrease in bacterial counts with the use of instillation therapy versus that of standard negative-pressure.