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| Name | Class |
|---|---|
| OrthoIndy | OTHER |
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The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.
Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insorb staples | Experimental | Subcuticular Absorbable staples |
|
| Control | Active Comparator | Metal staple wound closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insorb staples | Device | absorbable staples required for wound closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Incisional Drainage, Swelling or Gaps of Incision | Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters. | Discharge from initial hospital stay (2-5 days post-op) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Wound Complications - Hematoma | Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not. | up to 6 weeks post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Fisher, MD | Indiana Orthopaedic Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Orthopaedic Hospital | Indianapolis | Indiana | 46278 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insorb Staples | Subcuticular Absorbable staples Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples. |
| FG001 | Control | Metal staple wound closure Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insorb Staples | Subcuticular Absorbable staples |
| BG001 | Control | Metal staple wound closure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Participants With Incisional Drainage, Swelling or Gaps of Incision | Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters. | Posted | Number | participants | Discharge from initial hospital stay (2-5 days post-op) |
|
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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 | Insorb Staples | Subcuticular Absorbable staples Each participant will have a measured BMI, a measured incision length and documented number of Insorb staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Any palpation or protrusion of the Insorb staple will be documented and patients will be asked to rate comfort and pain related to the Insorb staples. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David A Fisher | OrthoIndy | (317) 802-2000 | dafisher@orthoindy.com |
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| ID | Term |
|---|---|
| D004890 | Erythema |
| D003288 | Contusions |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| metal staples (Ethicon metal stapler) | Device | wound closure with metal staples |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | number and sex of study participants | Count of Participants | Participants |
|
| Number of staples placed | we counted the number of staples used, collectively for all participants. This is a baseline number used for outcomes comparisons. | Number | staples |
|
| OG001 | Control-metal Staples | Metal staple wound closure Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure. |
|
|
| Secondary | Participants With Wound Complications - Hematoma | Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not. | Posted | Number | participants | up to 6 weeks post-op |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | Metal staple wound closure Each participant will have a measured BMI, a measured incision length and documented number of metal staples placed. At hospital discharge, 10 days post operatively and 6 weeks postoperatively, each participant will be evaluated for overall wound appearance, intactness of incision, gaping in the incision area, redness at the incision site, swelling at the incision site, a description of the surrounding tissue by the surgeon, documentation of incisional crusting, or fluid exudation. Patients will be asked to rate comfort and pain related to the metal staple wound closure. | 0 | 30 | 0 | 30 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D014949 | Wounds, Nonpenetrating |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |