Arthropathy, Joint Disease
Conditions
Keywords
Monocryl, Dermabond, Polyester mesh, Joint Disease, Arthropathy, Joint Replacement
Brief 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.
Interventions
DEVICEZipper 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.
OTHERMonocryl + Dermabond
conventional sutures and skin adhesive glue
OTHERPolyester mesh + Dermabond
conventional sutures and skin adhesive glue
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are undergoing joint arthroplasty
Exclusion criteria
* Treatment of total joint replacement surgery at an outside institution
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | 4 Days | The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line, and this rating is then measured from the left edge. The total range of score is 0-10; the higher the score the worse the pain (0 = no pain, 10 = worst pain imaginable). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zipper Surgical Skin Closure Zipper surgical skin closure device applied to the most superficial layer of skin following a joint arthroplasty
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. | 53 |
| Monocryl + Dermabond Monocryl suture plus Dermabond is a commonly used combination of wound closure techniques today.
Monocryl + Dermabond: conventional sutures and skin adhesive glue | 54 |
| 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
Polyester mesh + Dermabond: conventional sutures and skin adhesive glue | 53 |
| Total | 160 |
Baseline characteristics
| Characteristic | Zipper Surgical Skin Closure | Total | Polyester Mesh + Dermabond | Monocryl + Dermabond |
|---|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 8.75 | 65.78 years STANDARD_DEVIATION 9.45 | 66.51 years STANDARD_DEVIATION 8.92 | 64.56 years STANDARD_DEVIATION 10.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 24 Participants | 9 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 136 Participants | 44 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 9 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 20 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 32 Participants | 12 Participants | 12 Participants |
| Race (NIH/OMB) White | 30 Participants | 93 Participants | 33 Participants | 30 Participants |
| Region of Enrollment United States | 53 participants | 160 participants | 53 participants | 54 participants |
| Sex: Female, Male Female | 39 Participants | 107 Participants | 36 Participants | 32 Participants |
| Sex: Female, Male Male | 14 Participants | 53 Participants | 17 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 54 | 0 / 53 |
| other Total, other adverse events | 2 / 53 | 1 / 54 | 1 / 53 |
| serious Total, serious adverse events | 0 / 53 | 1 / 54 | 1 / 53 |
Outcome results
Primary
Visual Analog Scale (VAS) for Pain
The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line, and this rating is then measured from the left edge. The total range of score is 0-10; the higher the score the worse the pain (0 = no pain, 10 = worst pain imaginable).
Time frame: 4 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zipper Surgical Skin Closure | Visual Analog Scale (VAS) for Pain | 4.53 score on a scale | Standard Deviation 1.85 |
| Monocryl + Dermabond | Visual Analog Scale (VAS) for Pain | 4.48 score on a scale | Standard Deviation 1.78 |
| Polyester Mesh + Dermabond | Visual Analog Scale (VAS) for Pain | 4.54 score on a scale | Standard Deviation 1.76 |