NCT03134209

A 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-center, phase IV, randomized, prospective study investigating the efficacy of various wound closure devices in reducing postoperative wound complications.

Detailed description

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.

Conditions

• Joint Disease
• Arthropathy

Interventions

Type	Name	Description
DEVICE	Zipper surgical skin closure	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.
OTHER	Monocryl + Dermabond	conventional sutures and skin adhesive glue
OTHER	Polyester mesh + Dermabond	conventional sutures and skin adhesive glue

Timeline

• Start date: 2017-04-26
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2017-04-28
• Last updated: 2021-09-14
• Results posted: 2021-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study