Volume Reduction for Open Fracture Irrigation
ConditionOpen Fracture
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorInova Health Care Services
About this trial
The purpose of this study is to help doctors who treat open fractures understand how much fluid is required when cleaning out the wound. Participants will spend about 12 months in this study and will be asked to answer study questions about your recovery at your typical follow up clinic visits with your surgeon. After the surgeon has determined a participant's bone has healed, any remaining study visits can be conducted over the phone, email, and/or mail. Participants will not be asked to attend additional clinic visits as part of this study. Researchers will compare two different fluid volume protocols to determine if one results in better fracture and/or wound healing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Patient diagnosed with a Type I, II, or III open fracture of the appendicular skeleton by a study surgeon
For the purposes of this study, an open fracture is a fracture associated with a soft tissue wound which may or may not be contiguous with the fracture.
Open fractures of the carpals, tarsals, metacarpals, metatarsal, and/or phalanges without the involvement of a long bone or the hindfoot will not be considered.
Disqualifiers
Patient is unable to understand Informed Consent and/or HIPAA Authorization Form
Patient does not speak English
Patient is pregnant
Patient is unable or (in the judgment of research personnel) unlikely to attend follow-up visits.
Trial design
Design model
Parallel
Treatments tested in this trial
0.9% Sodium Chloride
DrugSterile 0.9% sodium chloride irrigation administered intraoperatively for the purposes of irrigating open fracture wounds. The volume of sterile 0.9% sodium chloride solution used during irrigation is determine by the arm participants are randomized to and the open fracture classification as determined by the study surgeon in the operating room.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Irrigation Protocol AActive comparator 1 intervention
Group B: Irrigation Protocol BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Surgical Site Infection (SSI) following irrigation and debridement of open fractures.
Surgical site infection within 90 days of I\&D, per CDC definition. The site of interest for this study is the wound created by the fracture mechanism and the debridement thereof. It does not refer to incisions required solely for fixation.
Time frame
90 days after first irrigation and debridement conducted in the operating roomSponsors and contacts
Click on the lead sponsor to view all of their trials.
Inova Health Care Services
Lead sponsor
Society of Military Orthopedic Surgeons
Collaborator
Source ClinicalTrials.gov