Open fractures of the lower limb Injury, Occupational Diseases, Poisoning Fracture of lower limb, level unspecified
Conditions
Interventions
Standard dressing.
The standard dressing for open fractures comprises a non-adhesive layer applied directly to the wound which is covered by a sealed dressing or bandage. The standard
Sponsors
University of Warwick (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or older 2. Present to the trial hospital within 72 hours of injury 3. Have an open fracture of the lower limb - graded as Gustilo and Anderson 2 or 3.
Exclusion criteria
Exclusion criteria: 1. There are contra-indications to anaesthesia such that the patient is unable to have surgery 2. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as permanent cognitive impairment. It is expected that for a very small proportion of patients this exclusion criterion will only be determined after randomisation has taken place. These patients will then be excluded from the study and no patient identifiable data will be retained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disability Rating Index (DRI) - a self administered, 12-item Visual Analogue Scale questionnaire assessing the patients' own rating of their disability. This measure was chosen as it addresses 'gross body movements' rather than specific joints or body segments. Therefore, it will facilitate the assessment of patients with different fractures of the lower limb. This data will be collected at baseline, 3, 6, 9 and 12 months post-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Deep Infection; We will use the Centers for Disease Control and Prevention definition of a 'deep surgical site infection': that is a wound infection involving the tissues deep to the skin that occurs in the first year following the injury. We will use photographs of the wound at the 6-week clinical follow-up in order to provide an objective assessment of wound healing and infection. X-rays taken at 6 weeks and 12 months post-injury will be assessed for further indicators of infection - periosteal reaction/lysis at 6 weeks and chronic osteomyelitis at 12 months post-injury. 2. EQ-5D - a validated, generalised, quality of life questionnaire consisting of 5 domains related to daily activities with a 3-level answer possibility. The combination of answers leads to the QoL score. 3. Complications - all complications will be recorded 4. SF-36; The Short-Form 36 is a validated and widely-used health-related quality of life measure 5. Resource use will be monitored for the economic analysis. Unit cost data will be obtained from national databases such as the BNF and PSSRU Costs of Health and Social Care. Where these are not available the unit cost will be estimated in consultation with the UHCW finance department. The cost consequences following discharge, including NHS costs and patients' out-of-pocket expenses will be recorded via a short questionnaire which will be administered at 3, 6, 9 and 12 months post surgery. Patient self-reported information on service use has been shown to be accurate in terms of the intensity of use of different services. | — |
Countries
United Kingdom
Outcome results
None listed