The secondary outcomes were HRQoL, deep SSI, other postoperative complications and resource use. Patient-reported outcomes, including the DRI, HRQoL measures, criteria for SSI and other complications, and health-care resource use, were collected by questionnaire at baseline, 3, 6, 9 and 12 months after randomisation. Baseline assessments were made primarily to allow study participants to retrospectively assess their pre-injury status. Definitions for outcomes and procedures for data collection are described below.
Health-related quality of life
Health-related QoL was captured using the following measures.
l EuroQoL-5 Dimensions (EQ-5D): a validated measure of HRQoL, consisting of a five-dimension health status classification system and a separate visual analogue scale (VAS).17Responses to the health status
classification system were converted into multiattribute utility (MAU) scores using a published utility algorithm, anchored at 1 (perfect health) and 0 (death).18These MAU scores were combined with survival
data to generate quality-adjusted life-year (QALY) profiles for the economic evaluation. In addition, health status was also assessed using the EQ-5D VAS, which required participants to assess their own health from the worst imaginable (0) to the best imaginable (100). These assessments were made by study participants pre injury (retrospectively),19immediately post injury and at 3, 6, 9 and 12 months post injury. l SF-12: a validated and widely used health-related QoL measure.17The UK factor score coefficients20were
used to give physical component scores (PCSs) and mental component scores (MCSs). Each permutation of response to the SF-12 was converted into a Short Form questionnaire 6-Dimensions (SF-6D) health utility score using a published utility algorithm.21These data were also combined with survival data to
generate QALY profiles for a sensitivity analysis within the economic evaluation. HRQoL using the SF-12 was assessed at pre-injury baseline (retrospectively recalled) and at 3, 6, 9 and 12 months post injury.
Surgical site infection and wound healing
The Centers for Disease Control and Prevention (CDC) definitions of SSIs were used (Box 1and see
Appendices 10and11). The CDC definition for superficial and deep SSIs is at 30 days following surgery (randomisation). Wounds were assessed and medical records reviewed at discharge, or at the first outpatient appointment after discharge from hospital if the patient was discharged before 30 days. Patients discharged before 30 days had their first follow-up appointment between 30 days and 6 weeks after surgery as part of normal clinical practice in the UK. Wounds were directly observed and infection characteristics were recorded by research staff. The CDC criteria23for deep SSI also include any deep infection occurring within 1 year if
an implant has been left in place. Therefore, we also recorded deep infection presenting within 12 months of the injury: any wound infection that required continuing medical or surgical intervention after 30 days, including infections leading to amputation, was considered a deep SSI.
Wound photographs
Wound photographs were taken at 6 weeks. A Samsung ES9 digital camera with flash (Samsung Electronics Limited, Surrey, UK) was given to each centre. Staff were trained to adhere to a standard wound protocol to ensure that images were of adequate quality (e.g. instructions for lighting). Nurses were instructed to remove wound dressings from the open-fracture wound and place a 15-cm paper ruler next to the wound for scaling. This paper ruler included the participant TNO. All images were password protected and returned to the trial co-ordinating centre. Photographs were reviewed blind to treatment allocation by two experienced wound healing specialists. Disagreement was resolved by a third reviewer.
Other postoperative complications
All complications and further surgical interventions related to the open-fracture wound or treatment of the wound were recorded using multiple approaches. Complications were documented at routine follow-up appointments, were self-reported by patients or were notified as adverse events (AEs) or serious adverse events (SAEs) (seeApproval for main trial).
All participants were invited for clinical review and a radiograph at 12 months, as per routine practice after this type of injury. If a participant had not returned a 12-month postal questionnaire, this was completed in clinic.
Radiographic images (radiographs)
Radiographic images were taken at 6 weeks and 12 months post surgery as part of routine follow-up for this group of patients. Standard anteroposterior and lateral radiographs were taken at each centre. Copies of original radiographs were stored on a secure compact disc and returned to the central trial office. The radiographs were reviewed by an independent surgeon who was blinded to the treatment allocation. As part of the assessment of complications, each set of radiographic images was assessed for failure of fixation (yes or no). For long-bone fractures, the sagittal and coronal angulation were measured for the index fixation; sagittal angulation>10° and coronal angulation>5° were considered to be clinically important. At 12 months, each set of radiographs was also assessed for bony union (bridging cortical bone across three cortices).
Health-care and social care resource use
Resource use was measured for the purposes of the health economic evaluation. Unit cost data were obtained from national databases such as the BNF24and Personal Social Services Research Unit (PSSRU)’s Unit Costs of Health and Social Care 2012.25When these were not available, the unit cost was estimated in
BOX 1 Centers for Disease Control and Prevention definition for deep SSI22
Deep incisional surgical site infection
Must meet the following criteria:
Infection occurs within 30 days after the operative procedure if no implant is left in place or within 1 year if an implant is in place and the infection appears to be related to the operative procedure.
AND
Involves deep soft tissues of the incision (e.g. fascial and muscle layers). AND
Patient has at leastoneof the following:
l Purulent drainage from the deep incision but not organ/space component of surgical site.
l A deep incision that spontaneously dehisces or is deliberately opened by a surgeon and is culture-positive or not cultured when the patient has at least one of the following signs or symptoms: fever (>38 °C), or localised pain or tenderness. A culture-negative finding does not meet this criterion.
l An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation or by histopathologic or radiological examination.
consultation with the University Hospitals Coventry and Warwickshire (UHCW) NHS Trust finance department. The cost–consequences following hospital discharge, including NHS costs and patients’ out-of-pocket expenses, were estimated using questions included within a questionnaire sent to participants at 3, 6, 9 and 12 months post randomisation. Patient self-reported information on service use has previously been shown to be accurate in terms of the intensity of use of different services.26