A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures
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|ClinicalTrials.gov Identifier: NCT01315392|
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : March 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type II and IIa Open Tibia Fractures||Procedure: delayed closure Procedure: immediate wound closure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||451 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study|
|Study Start Date :||July 2000|
Active Comparator: delayed closure
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.
Procedure: delayed closure
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.
Active Comparator: immediate wound closure
traumatic and surgical wounds closed at initial surgical intervention
Procedure: immediate wound closure
traumatic and surgical wounds closed at the initial surgical intervention
- infection ratedefined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site.
- hospital readmissionsneed for additional procedures and hospital readmissions related to the index injury will be documented
- tibial fracture healingevidence of bridging callus on three of four cortices assessed by biplanar radiograph
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315392
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator:||Michael J Bosse, MD||Carolians HealthCare System|