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Barbed sutures offer several potential advantages in layered wound closure of hip and knee replacement surgeries. It use is gaining increased acceptance across many of the other surgical disciplines at this time. The purpose of this study is to evaluate the use of Quill as part of our layered closure compared to using our traditional sutures. The study timeline begins at the time of the surgical procedure and continues through the routine follow-up of total joint replacements at 2, 6, and 12 weeks, and will conclude at the six month post-operative office visit.
Primary Objectives:
Secondary Objectives:
We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated. Closure was noted to be significantly faster (9.3 vs 13.6 minutes, P b .005) in the barbed suture group. Wound-related complications were similar (3 cases) in both groups at 3-month follow-up. Although this study supports the use of barbed technology as a functionally comparable and more efficient modality of wound closure with the potential for costs savings based on reduced operative time, the cost-effectiveness of its adoption is institution dependent and will rely on the optimization of all other perioperative factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Knotless suture for wound closure |
|
| 2 | Active Comparator | Layered traditional wound closure (monocryl) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knotless suture for wound closure | Device | Angiotech Quill SRS |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Closure Time | We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-analysis | Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs | 1 year |
| Visual Analog Score, Cosmesis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett R Levine, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush university Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18619922 | Background | Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10. | |
| 17949320 | Background | Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007 Oct;21(10):1175-8. doi: 10.1089/end.2007.9913. |
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No participants were excluded except those that would not sign consent. 5 patients were excluded as they did not want to participate giving us 65 offers and 60 enrollments.
This single-blinded, prospective, randomized trial was conducted from February 2009 through June 2009 and was approved by our institutional review board. Recruitment was in our office only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Knotless suture for wound closure |
| FG001 | Control Group | Layered traditional wound closure (monocryl) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Knotless suture for wound closure |
| BG001 | Control Group | Layered traditional wound closure (monocryl) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Closure Time | We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated. | A power analysis was performed based on mean closure times by the 2 surgeons and determined that a sample size of 23 patients in each group would provide 90% power to detect a 50% difference in closure time. To account for patients being lost to FU, we enrolled 29 to the traditional closure group and 31 to the barbed closure group | Posted | Mean | Full Range | Average time in minutes | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Knotless suture for wound closure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Fall | Systematic Assessment | Patient fell after surgery. Not related to the treatment arm, but required re-operation for arthrotomy rupture. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| incisional erythema | Infections and infestations | Systematic Assessment | 2 in the barbed suture and 3 in the traditional closure group developed incisional erythema, and all resolved with oral antibiotics. |
Five patients were offered enrollment but refused to participate, however this does not alter our data as sixty others did enroll.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brett R. Levine | Rush University Medical Center | 312-432-2466 | brettlevine@gmail.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Layered traditional wound closure (monocryl) | Device | Layered traditional wound closure (monocryl) |
|
|
Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis.
1 is an unacceptable or poor perspective in regards to wound cosmesis.
| 6 months |
| 18317092 | Background | Villa MT, White LE, Alam M, Yoo SS, Walton RL. Barbed sutures: a review of the literature. Plast Reconstr Surg. 2008 Mar;121(3):102e-108e. doi: 10.1097/01.prs.0000299452.24743.65. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Control Group |
Layered traditional wound closure (monocryl) |
|
|
| Secondary | Cost-analysis | Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs | Power analysis was performed as above. | Posted | Mean | Standard Deviation | Dollars | 1 year |
|
|
|
| Secondary | Visual Analog Score, Cosmesis | Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis. 1 is an unacceptable or poor perspective in regards to wound cosmesis. | Power analysis described above | Posted | Mean | Full Range | units on a scale (1 is a low score) | 6 months |
|
|
|
| 1 |
| 31 |
| 2 |
| 31 |
| EG001 | Control Group | Layered traditional wound closure (monocryl) | 0 | 29 | 3 | 29 |
|
|
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| D012216 |
| Rheumatic Diseases |