A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
Status: | Recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/22/2018 |
Start Date: | April 26, 2017 |
End Date: | December 2019 |
Contact: | Pankaj Patel |
Email: | pankaj.patel@nyumc.org |
Phone: | 646 356 9405 |
A Single-center, Phase IV, Randomized, Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
A single-center, phase IV, randomized, prospective study investigating the efficacy of
various wound closure devices in reducing postoperative wound complications.
various wound closure devices in reducing postoperative wound complications.
The zipper wound technology is a new wound closure device that is an alternative to the
commonly used conventional staples and sutures. The device acts like a scaffold to stabilize
the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of
the skin. The other treatment groups include monocryl + Dermabond (conventional sutures and
skin adhesive glue) and polyester mesh + Dermabond. All products have been FDA approved. A
randomized control trial will provide the highest level of evidence without altering the
potential risks to the patient as all three wound closure techniques have been found to have
comparable complication rates. The three different treatment devices will be administered
following the normal standard of care. All three wound closure devices are currently being
used at NYULMC. No modifications to the normal standard of practice other than the
randomization process will be implemented. Given the nature of the application of the wound
closure device, which will be visible to the surgeon at the time of application and the
patient postoperatively, the study will not be blinded to either the surgeon or the patient.
Prior to discharge, a blinded plastic surgeon will be asked to assess the wound based on
comesis and overall quality of wound healing.
commonly used conventional staples and sutures. The device acts like a scaffold to stabilize
the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of
the skin. The other treatment groups include monocryl + Dermabond (conventional sutures and
skin adhesive glue) and polyester mesh + Dermabond. All products have been FDA approved. A
randomized control trial will provide the highest level of evidence without altering the
potential risks to the patient as all three wound closure techniques have been found to have
comparable complication rates. The three different treatment devices will be administered
following the normal standard of care. All three wound closure devices are currently being
used at NYULMC. No modifications to the normal standard of practice other than the
randomization process will be implemented. Given the nature of the application of the wound
closure device, which will be visible to the surgeon at the time of application and the
patient postoperatively, the study will not be blinded to either the surgeon or the patient.
Prior to discharge, a blinded plastic surgeon will be asked to assess the wound based on
comesis and overall quality of wound healing.
Inclusion Criteria:
- Patients who are undergoing joint arthroplasty
Exclusion Criteria:
- Treatment of total joint replacement surgery at an outside institution
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Ran Schwarzkopf, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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