Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data suggests barbed suture represents no increased complications in the revision setting. Barbed suture may represent a faster, more effective way to perform revision arthroplasty closures. There are no Level I studies comparing traditional and barbed suture closure. The purpose of this study is to assess the surgical complexities of closures using closure time without sacrificing cosmesis or wound complications between the traditional closure and barbed closure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revision total knee arthroplasty: control | Active Comparator |
| |
| Revision total knee arthroplasty: active | Experimental |
| |
| Revision Total Hip Arthroplasty: control | Active Comparator |
| |
| Revision Total Hip Arthroplasty: active | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Closure: Knee | Device | Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson & Johnson) and Dermabond advanced. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Closure in Minutes | Measurement of the time needed to properly close the wound with each technique. | Up to a maximum of 66 minutes (perioperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Complications Related to Wound Closure | Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure. | Day 90 |
| Patient and Observer Scar Assessment Scale (POSAS) Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Vulnerable populations will not be enrolled in this study.
Withdrawal Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ran Schwarzkopf, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Requests should be directed to ran.schwarzkopf@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Revision Total Knee Arthroplasty: Control | Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson & Johnson) and Dermabond advanced. |
| FG001 | Revision Total Knee Arthroplasty: Active | Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance. |
| FG002 | Revision Total Hip Arthroplasty: Control | Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson). |
| FG003 | Revision Total Hip Arthroplasty: Active | Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson & Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Revision Total Knee Arthroplasty: Control | Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson & Johnson) and Dermabond advanced. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time of Closure in Minutes | Measurement of the time needed to properly close the wound with each technique. | Posted | Mean | Full Range | minutes | Up to a maximum of 66 minutes (perioperative) |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Revision Total KNEE Arthroplasty: Control (Conventional Closure) | Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson & Johnson) and Dermabond advanced. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent effusion | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ran Schwarzkopf, MD | NYU Langone Health | 646-501-7070 | Ran.Schwarzkopf@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2020 | Mar 12, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
prospective, randomized, controlled trial, parallel four-arm design, single-center study
Not provided
Not provided
Not provided
Not provided
|
| Barbed suture closure: Knee | Device | The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance. |
|
| Conventional Closure: Hip | Device |
|
|
| Barbed suture closure: Hip | Device |
|
|
The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale, where 0 = normal skin and 10 = worst scar imaginable. Together they make up the 'Total Score' of the Patient and Observer Scale, which ranges from 0 to 120; higher scores indicate worse scars.
| Week 6 Post-Surgery |
| Mean Number of Sutures Used | 45 minutes (perioperative) |
| Mean Length of Incision | 30 minutes (perioperative) |
| BG001 | Revision Total Knee Arthroplasty: Active | Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance. |
| BG002 | Revision Total Hip Arthroplasty: Control | Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson). |
| BG003 | Revision Total Hip Arthroplasty: Active | Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson & Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance. |
| OG002 | Revision Total HIP Arthroplasty: Control (Conventional Closure) | Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson). |
| OG003 | Revision Total HIP Arthroplasty: Active (Barbed Suture Closure) | Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson & Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson). |
|
|
| Secondary | Incidence of Complications Related to Wound Closure | Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure. | Posted | Number | Total number of complications | Day 90 |
|
|
|
| Secondary | Patient and Observer Scar Assessment Scale (POSAS) Score | The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale, where 0 = normal skin and 10 = worst scar imaginable. Together they make up the 'Total Score' of the Patient and Observer Scale, which ranges from 0 to 120; higher scores indicate worse scars. | Posted | Mean | Full Range | score on a scale | Week 6 Post-Surgery |
|
|
|
| Secondary | Mean Number of Sutures Used | Posted | Mean | Full Range | sutures | 45 minutes (perioperative) |
|
|
|
| Secondary | Mean Length of Incision | Posted | Mean | Full Range | millimeters | 30 minutes (perioperative) |
|
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| 1 |
| 22 |
| EG001 | Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure) | Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance. | 0 | 30 | 2 | 30 | 2 | 30 |
| EG002 | Revision Total HIP Arthroplasty: Control (Conventional Closure) | Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson). | 0 | 18 | 0 | 18 | 1 | 18 |
| EG003 | Revision Total HIP Arthroplasty: Active (Barbed Suture Closure) | Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson & Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson). | 0 | 11 | 0 | 11 | 1 | 11 |
| Traumatic wound dehisence | General disorders | Non-systematic Assessment |
|
| Lateral capsule weekness and herniation | Surgical and medical procedures | Non-systematic Assessment |
|
| Delayed wound healing | General disorders | Non-systematic Assessment |
|
| Instability/Dislocation | General disorders | Non-systematic Assessment |
|
| Recurrent effusion | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
Not provided