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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
| Orthopaedic Research and Education Fund | UNKNOWN |
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Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delayed closure | Active Comparator | wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for debridement and definitive closure. |
|
| immediate wound closure | Active Comparator | traumatic and surgical wounds closed at initial surgical intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delayed closure | Procedure | wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for a second debridement and definitive closure. |
| Measure | Description | Time Frame |
|---|---|---|
| infection rate | defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site. | |
| hospital readmissions | need for additional procedures and hospital readmissions related to the index injury will be documented | |
| tibial fracture healing | evidence of bridging callus on three of four cortices assessed by biplanar radiograph |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Bosse, MD | Carolians HealthCare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
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| immediate wound closure | Procedure | traumatic and surgical wounds closed at the initial surgical intervention |
|