Comparison of the effectiveness and outcome of antibiotic cemented nails with external fixators in patients with open long bone fractures Gustilo and Anderson type 3
Comparison of the results (complications and outcome) of antibiotic cemented nails with external fixators in patients with open long bone fractures Gustilo and Anderson type 3
Design
Two parallel groups of 35 patients non randomized with open long bone fractures of Gastilo and Anderson type 3 treated by custom made antibiotic cemented nail in intervention 1 group and external fixators in intervention 2 group.
Settings and conduct
Two packs of 40-gram bone cement powder and 2 grams of vancomycin were mixed by vacuum mixer. Then, the low viscous cement was injected into the chest tube. The injected cement must be bubble-free. Based on the natural shape of the bone, the chest tube was bowed. After the cement hardened, the chest tube was cut longitudinally. Afterward, the cement nail was polished.
The bone's internal cortex was rimmed. Based on the standard operational technique for each bone, the antibiotic cement nail was inserted, and then the proper position was checked with C-arm.
The proximal and distal parts of TEN were bent for easier removal
External fixators were used for intervention 2 groups in operation room Taleghani Hospital Tehran
Participants/Inclusion and exclusion criteria
Patients entering Taleghani Hospital with long bone open fractures Gastilo and Anderson type 3
Exclusion criteria: Pregnancy, planning for pregnancy, breastfeeding, renal failure, allergy to vancomycin
Intervention groups
Using custom made antibiotic cemented mixed with vancomycin nail in intervention 1 group and external fixators in the intervention 2 group
Main outcome variables
Fracture union, infection,hospital stay and number of surgical operations needed for healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039188N3
Registration date:2022-06-20, 1401/03/30
Registration timing:prospective
Last update:2022-06-20, 1401/03/30
Update count:0
Registration date
2022-06-20, 1401/03/30
Registrant information
Name
Reza Zandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
reza.zandi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness and outcome of antibiotic cemented nails with external fixators in patients with open long bone fractures Gustilo and Anderson type 3
Public title
Comparison of the effectiveness and outcome of antibiotic cemented nails with external fixators in patients with open long bone fractures Gustilo and Anderson type 3
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Long bone open fractures type 3 Gastilo and Anderson
Exclusion criteria:
Pregnancy
Planning for pregnancy
Renal failure
Vancomycin allergy
Breast feeding
Age
From 11 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization for 2 intervention groups, will done using software, similar random numbers for each group.
The surgeon can not play a role in predicting treatment of the disease, and choosing the type of treatment. Random sequence will generate by software.
All admitted patients will be placed in one of the groups according to the pre-determined code
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
School of Medicine, Koodakyar street, Shahid Shahriari Square, Chamran highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.087
Health conditions studied
1
Description of health condition studied
Gustilo-Anderson type III lower open limb fractures