Trials / Unknown
UnknownNCT04681846
Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- Assiut University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Assessment of the efficacy of the multistage technique in the eradication of infection and achieving the union of traumatic infected femoral un-united shaft fractures in adult patients for one year follow up.
Detailed description
All cases will be treated by the induced membrane technique in two stages. In the first stage, thorough debridement of the infected bone and soft tissues and copious lavage will be done. After radical debridement, primary fixation will be done by either external fixation or antibiotic cement coated internally fixed implants.If there is a bone defect, it will be measured and filled with an antibiotic-impregnated (PMMA) cement spacer. The second stage procedure will be performed 4 to 8 weeks after the first one if soft tissue permits and only if there is no clinical or biochemical evidence of ongoing infection as indicated by normal white blood cell count, C-reactive protein, and erythrocyte sedimentation rate. It includes the exchange of the antibiotic cement spacer by a cancellous bone graft.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Staged approach using antibiotic-cement impregnated PMMA spacer | It will be prepared in the following manner. the cement will be mixed with vancomycin in a ratio of 2 gm to each 40 gm of the spacer. The spacer should be shaped into a cylinder before its solidification. The spacer should be as big as possible to fill the whole defect, without compromising the soft tissue and skin closure. Also, cement should wrap the two ends of bone extremities on 2 or 3 centimeters. |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2022-08-01
- Completion
- 2022-10-01
- First posted
- 2020-12-23
- Last updated
- 2020-12-23
Source: ClinicalTrials.gov record NCT04681846. Inclusion in this directory is not an endorsement.