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This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision >3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Wound Care | No Intervention | Patients randomized to the control group will receive standard wound care. | |
| Incisional Negative Pressure Wound Therapy (NPWT) | Experimental | Patients randomized to the treatment group will receive wound care which includes the application of an incisional negative pressure wound vacuum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incisional Negative Pressure Wound Therapy (NPWT) | Device | Participants in the treatment group will be standardized and will receive incisional NPWT using the any incisional VAC system that can apply 75-125mmHg continuous suction to the incision. The VAC sponge will be placed over the surgical wound at least 2cm in width and >3cm in length. |
| Measure | Description | Time Frame |
|---|---|---|
| Complication composite outcome | The primary outcome will be a composite outcome. We will hierarchically assess the components of the composite outcome in the following order: (1) all-cause mortality, (2) injury-related amputation of the lower extremity, (3) number of surgeries to treat a deep or organ space infection (CDC criteria), (4) wound healing complications requiring reoperation, (5) nonoperative wound necrosis at 2 or 6 weeks, wound dehiscence at 2 or 6 weeks or superficial infection (CDC criteria), (6) SCAR-Q Symptom Scale, (7) SCAR-Q Appearance Scale | 3 months |
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Inclusion Criteria:
All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed.
We define high-risk fractures as those that are either:
Requiring incision for fixation or debridement of 3 cm or greater.
Patients 18 years of age or older
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leah Gitajn, MD | Contact | 603-650-5133 | ida.leah.gitajn@hitchcock.org |
| Name | Affiliation | Role |
|---|---|---|
| I. Leah Gitajn, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Renan Castillor, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland R Adams Cowley Shock Trauma Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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Randomization into study treatment arms (incisional NPWT or non-suction standard of care) will occur in variable permuted blocks, stratified by clinical center, in a 1:1 ratio. Patients will be randomized electronically by an online Data Management System maintained by the Coordinating Center at Johns Hopkins School of Public Health.
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| University of Maryland Shock Trauma/Capitol Regions | Recruiting | Baltimore | Maryland | 21201 | United States |
|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| Vanderbilt University | Recruiting | Nashville | Tennessee | 37232 | United States |
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| UTHealth/McGovern Medical School | Recruiting | Houston | Texas | 77030 | United States |
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| Inova Fairfax MEdical Campus | Recruiting | Falls Church | Virginia | 22042 | United States |
|
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D007239 | Infections |
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