A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
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ClinicalTrials.gov Identifier: NCT03134209 |
Recruitment Status :
Completed
First Posted : April 28, 2017
Last Update Posted : February 2, 2021
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Condition or disease | Intervention/treatment | Phase |
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Joint Disease Arthropathy | Device: Zipper surgical skin closure Other: Monocryl + Dermabond Other: Polyester mesh + Dermabond | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty will be compared to two groups: 1) Monocryl + Dermabond 2) Polyester mesh + Dermabond |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single-center, Phase IV, Randomized, Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications |
Actual Study Start Date : | April 26, 2017 |
Actual Primary Completion Date : | August 31, 2020 |
Actual Study Completion Date : | August 31, 2020 |

Arm | Intervention/treatment |
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Experimental: Zipper surgical skin closure
Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty
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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. |
Active Comparator: Monocryl + Dermabond
Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
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Other: Monocryl + Dermabond
conventional sutures and skin adhesive glue |
Active Comparator: Polyester mesh + Dermabond
The polyester plus Dermabond closure techniques combines the OCA topical skin adhesive with a flexible, self-adhesive polyester mesh that has proven to reduce wound cosure times and have a significant greater skin holding strength than skin staples or subcuticular sutures in one study
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Other: Polyester mesh + Dermabond
conventional sutures and skin adhesive glue |
- Visual Analog Scale for Pain (VAS Pain) [ Time Frame: 4 Days ]The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who are undergoing joint arthroplasty
Exclusion Criteria:
- Treatment of total joint replacement surgery at an outside institution

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134209
United States, New York | |
New York University School of Medicine | |
New York, New York, United States, 10016 |
Principal Investigator: | Ran Schwarzkopf | NYU Langone Health |
Responsible Party: | NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT03134209 |
Other Study ID Numbers: |
16-02020 |
First Posted: | April 28, 2017 Key Record Dates |
Last Update Posted: | February 2, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Monocryl Dermabond Polyester mesh |
Joint Disease Arthropathy Joint Replacement |
Joint Diseases Musculoskeletal Diseases |