Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05251064 |
| Other study ID # |
21411 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 23, 2019 |
| Est. completion date |
January 20, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
University of Virginia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is trying to find out if there is one method of surgical incision closure is
better than another. The three different wound closure methods in this study are currently
used in standard of care. The three methods being compared are standard stitches and the
wound closure devices, Clozex, and Zipline. All of these methods are approved by the FDA.
Description:
There are many surgical wound closure methods commonly used in practice today. These usually
involve a combination of braided and monofilament sutures in the subcutaneous fascia and fat
as well as the subcuticular layers of the skin. The methods chosen by surgeons vary widely
even amongst partners at the same institution for many reasons, including training background
and conflicting reports in the literature. In some cases, these closure techniques can be
time consuming and associated with increased rates of poor cosmetic outcomes or
complications. There have been new wound closure products to reach the market that have been
designed (Zipline - Campbell, CA and Clozex - Wellesley, MA), claiming to increase the speed
of closure and decrease the rate of complications. These products both utilize an adhesive
backed film to adhere to the skin along with a proprietary method to enhance skin apposition
to reduce tension during the healing process. There has been no randomized controlled trial
to determine superiority of the above listed surgical closure methods compared to traditional
methods.
Our study aims to compare a "traditional" wound closure using both braided and monofilament
sutures to the newer wound closure systems. By determining which method provides superior
results, we will improve patient outcomes and satisfaction. The study also aims to assess
health care value by exploring the costs associated with each closure technique. In addition
to material expenses associated with the traditional sutures, we seek to explore if there is
a significant difference in the time required to perform each wound closure method. Every
minute of anesthesia and operating room utilization is associated with costs borne by the
patient and the health care system. By finding which closure method is the fastest and
associated with the best outcome we can improve healthcare value.
These methods will be tested in a randomized controlled trial and will be analyzed with
multivariate statistical analysis to examine statistical significance. Subjects will be
randomized in a 1:1:1 fashion to sutures, Closex, or Zipline. Surgeons will complete a
satisfaction questionnaire about the randomized method used for closure. Surgical subjects
will complete a satisfaction questionnaire at two follow up visits that align with standard
of care visits and will have the incision measured and examined. Our primary objective
outcome measure will be an assessment of surgical scar dimensions. Our hypothesis is that the
3 study groups will have similar objective scar measurements but that the savings in time
associated with the new wound closure methods will be significant.
