Dataset Information

Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb: The WOLLF Randomized Clinical Trial.

ABSTRACT:

Importance

Open fractures of the lower limb occur when a broken bone penetrates the skin. There can be major complications from these fractures, which can be life-changing.

Objectives

To assess the disability, rate of deep infection, and quality of life in patients with severe open fracture of the lower limb treated with negative pressure wound therapy (NPWT) vs standard wound management after the first surgical debridement of the wound.

Design, setting, and participants

Multicenter randomized trial performed in the UK Major Trauma Network, recruiting 460 patients aged 16 years or older with a severe open fracture of the lower limb from July 2012 through December 2015. Final outcome data were collected through November 2016. Exclusions were presentation more than 72 hours after injury and inability to complete questionnaires.

Interventions

NPWT (n?=?226) in which an open-cell solid foam or gauze was placed over the surface of the wound and connected to a suction pump, creating a partial vacuum over the dressing, vs standard dressings not involving application of negative pressure (n?=?234).

Main outcomes and measures

Disability Rating Index score (range, 0 [no disability] to 100 [completely disabled]) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. Secondary outcomes were complications including deep infection and quality of life (score ranged from 1 [best possible] to -0.59 [worst possible]; minimal clinically important difference, 0.08) collected at 3, 6, 9, and 12 months.

Results

Among 460 patients who were randomized (mean age, 45.3 years; 74% men), 88% (374/427) of available study participants completed the trial. There were no statistically significant differences in the patients' Disability Rating Index score at 12 months (mean score, 45.5 in the NPWT group vs 42.4 in the standard dressing group; mean difference, -3.9 [95% CI, -8.9 to 1.2]; P?=?.13), in the number of deep surgical site infections (16 [7.1%] in the NPWT group vs 19 [8.1%] in the standard dressing group; difference, 1.0% [95% CI, -4.2% to 6.3%]; P?=?.64), or in quality of life between groups (difference in EuroQol 5-dimensions questionnaire, 0.02 [95% CI, -0.05 to 0.08]; Short Form-12 Physical Component Score, 0.5 [95% CI, -3.1 to 4.1] and Mental Health Component Score, -0.4 [95% CI, -2.2 to 1.4]).

Conclusions and relevance

Among patients with severe open fracture of the lower limb, use of NPWT compared with standard wound dressing did not improve self-rated disability at 12 months. The findings do not support this treatment for severe open fractures.

Trial registration

isrctn.org Identifier: ISRCTN33756652.

SUBMITTER: Costa ML

PROVIDER: S-EPMC6583504 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb: The WOLLF Randomized Clinical Trial.

Costa Matthew L ML Achten Juul J Bruce Julie J Tutton Elizabeth E Petrou Stavros S Lamb Sarah E SE Parsons Nick R NR

JAMA 20180601 22

<h4>Importance</h4>Open fractures of the lower limb occur when a broken bone penetrates the skin. There can be major complications from these fractures, which can be life-changing.<h4>Objectives</h4>To assess the disability, rate of deep infection, and quality of life in patients with severe open fracture of the lower limb treated with negative pressure wound therapy (NPWT) vs standard wound management after the first surgical debridement of the wound.<h4>Design, setting, and participants</h4>Mu ...[more]

PMID: 29896626

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Project description:ImportanceFollowing surgery to treat major trauma-related fractures, deep wound infection rates are high. It is not known if negative pressure wound therapy can reduce infection rates in this setting.ObjectiveTo assess outcomes in patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either incisional negative pressure wound therapy or standard wound dressing.Design, setting, and participantsA randomized clinical trial conducted at 24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018.InterventionsIncisional negative pressure wound therapy (n = 785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure (n = 763).Main outcomes and measuresThe primary outcome measure was deep surgical site infection at 30 days diagnosed according to the criteria from the US Centers for Disease Control and Prevention. A preplanned secondary analysis of the primary outcome was performed at 90 days. The secondary outcomes were patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications at 30 days.ResultsAmong 1548 participants who were randomized (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 1519 (98%) had data available for the primary outcome. At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, -0.77% [95% CI, -3.19% to 1.66%]; P = .52). There was no significant difference in the deep surgical site infection rate at 90 days (11.4% [72 of 629 patients] in the incisional negative pressure wound therapy group vs 13.2% [78 of 590 patients] in the standard wound dressing group; odds ratio, 0.84 [95% CI, 0.59 to 1.19]; absolute risk difference, -1.76% [95% CI, -5.41% to 1.90%]; P = .32). For the 5 prespecified secondary outcomes reported, there were no significant differences at any time point.Conclusions and relevanceAmong patients who underwent surgery for major trauma-related lower limb fractures, use of incisional negative pressure wound therapy, compared with standard wound dressing, resulted in no significant difference in the rate of deep surgical site infection. The findings do not support the use of incisional negative pressure wound therapy in this setting, although the event rate at 30 days was lower than expected.Trial registrationisrctn.org Identifier: ISRCTN12702354.

Project description:BackgroundHip fracture is an important and frequent health problem worldwide. To date, there are still limited studies focused on the analysis of health-related quality of life (HRQOL) after a hip fracture in the Spanish population, especially with long-term follow-up.ObjectiveTo determine the HRQOL at 12 months after hip fracture and to identify potential factors associated with HRQOL.DesignProspective observational study.SettingTraumatology units of two university hospitals in province Cáceres (Spain).ParticipantsA total of 224 patients were admitted to the unit and required immediate surgery due to a hip fracture.MethodsHRQOL was measured with the EuroQol-5D questionnaire (EQ-5D) and the SF-12 Health Survey.ResultsScores from the visual analog scale EQ-5D decreased significantly (p < 0.001) from 72.8 at baseline to 48.3 after 1 month, to 48.2 after 6 months and to 46.1 after 12 months. The EQ-5D index score showed a similar significant reduction (p < 0.001) from 0.6 to 0.1, 0.3 and 0.3, respectively. Values of the physical component summary (PCS-12) significantly decreased (p < 0.001) from 38.6 at baseline to 31.0, 33.1 and 33.5. The mental component summary (MCS-12) decreased from 46.5 to 44.8 after 6 months (p = 0.022) and 44.3 after 12 months (p = 0.005). Factors potentially associated with HRQOL at 12 months after hip fracture were depression status after 12 months (B = 0-1.876; 95% CI [-2.409 to -1.343]; p < 0.001), functional ambulation classification after 12 months (B = -12.133; 95% CI [-17.970 to -6.297]; p < 0.001), EQ-5D VAS at baseline (B = 0.223; 95% CI [0.115-0.330]; p < 0.001), and age (B = -0.323; 95% CI [-0.594 to -0.053; p = 0.015).ConclusionsPatients experience a significant impairment in HRQOL H after a hip fracture, especially in self-care, pain/discomfort, usual activities, mobility and anxiety/depression. The decline in the HRQOL is effective the first month and lasts at least 12 months after the surgical intervention.

Project description:PurposeIn the surgical treatment for lower-leg intra-articular fractures, the fragments have to be positioned and aligned to reconstruct the fractured bone as precisely as possible, to allow the joint to function correctly again. Standard procedures use 2D radiographs to estimate the desired reduction position of bone fragments. However, optimal correction in a 3D space requires 3D imaging. This paper introduces a new navigation system that uses pre-operative planning based on 3D CT data and intra-operative 3D guidance to virtually reduce lower-limb intra-articular fractures. Physical reduction in the fractures is then performed by our robotic system based on the virtual reduction.Methods3D models of bone fragments are segmented from CT scan. Fragments are pre-operatively visualized on the screen and virtually manipulated by the surgeon through a dedicated GUI to achieve the virtual reduction in the fracture. Intra-operatively, the actual position of the bone fragments is provided by an optical tracker enabling real-time 3D guidance. The motion commands for the robot connected to the bone fragment are generated, and the fracture physically reduced based on the surgeon's virtual reduction. To test the system, four femur models were fractured to obtain four different distal femur fracture types. Each one of them was subsequently reduced 20 times by a surgeon using our system.ResultsThe navigation system allowed an orthopaedic surgeon to virtually reduce the fracture with a maximum residual positioning error of [Formula: see text] (translational) and [Formula: see text] (rotational). Correspondent physical reductions resulted in an accuracy of 1.03 ± 0.2 mm and [Formula: see text], when the robot reduced the fracture.ConclusionsExperimental outcome demonstrates the accuracy and effectiveness of the proposed navigation system, presenting a fracture reduction accuracy of about 1 mm and [Formula: see text], and meeting the clinical requirements for distal femur fracture reduction procedures.

Dataset Information

Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb: The WOLLF Randomized Clinical Trial.

Importance

Objectives

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb: The WOLLF Randomized Clinical Trial.

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