Wound healing in surgical trauma

Conditions

Patients with major trauma requiring surgery for a fracture to the lower limb. Musculoskeletal Diseases Major trauma

Matthew L. Costa, Juul Achten, Ruth Knight, May Ee Png, Julie Bruce et al. (17 authors)

Health Technology Assessment2020-08-0117 citations

Effect of Incisional Negative Pressure Wound Therapy vs Standard Wound Dressing on Deep Surgical Site Infection After Surgery for Lower Limb Fractures Associated With Major Trauma

Matthew L. Costa, Juul Achten, Ruth Knight, Julie Bruce, Susan Dutton et al. (53 authors)

JAMA2020-02-11131 citations

10.1001/jama.2020.0059

Wound Healing In Surgery for Trauma (WHIST): statistical analysis plan for a randomised controlled trial comparing standard wound management with negative pressure wound therapy

Ruth Knight, Louise Spoors, Matthew L. Costa, Susan Dutton

Trials2019-03-2813 citations

10.1186/s13063-019-3282-y

Standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb—a two-arm parallel group superiority randomised controlled trial: protocol for Wound Healing in Surgery for Trauma (WHIST)

Juul Achten, Karan Vadher, Julie Bruce, Jagdeep Nanchahal, Louise Spoors et al. (9 authors)

BMJ Open2018-06-0113 citations

10.1136/bmjopen-2018-022115

Interventions

Patients with a fracture of the lower limb associated with major trauma usually have surgery on the next available trauma operating list. Some patients may be transferred to a Major Trauma Centre for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria (as of 18/12/2017): 1. Aged 16 years or older 2. Present to hospital within 72 hours of injury 3. Presence of major trauma (as defined by eligibility for the UK Trauma Audit Research Network (TARN) database) 4. Presence of a lower limb fracture requiring a surgical incision Previous participant inclusion criteria: 1. Aged 16 years or older 2. Present to the trial hospital within 72 hours of injury 3. Presence of major trauma (as defined by eligibility for the UK Trauma Audit Research Network (TARN) database) 4. Presence of a limb fracture requiring a surgical incision

Exclusion criteria

Exclusion criteria: 1. An open fracture of the lower limb which cannot be closed primarily 2. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires

Design outcomes

Primary

Measure	Time frame
Deep infection rate in lower limbs is measured 30 days post-injury by the patient’s treating clinical team using the Centre for Disease Control and Prevention definition of a deep surgical site infection.	—

Secondary

Measure	Time frame
Current secondary outcome measures (as of 18/12/2017): 1. Disability and quality of life are measured using the Disability Rating Index and the EQ-5D-5L at baseline (retrospective) and 3 and 6 months post-injury 2. Wound healing is measured using a validated patient reported questionnaire at 30 days, 3 and 6 months post-injury 3. Number and nature of further surgical interventions is assessed using patients medical records and patient self-report at 30 days, 3 and 6 months 4. Cost effectiveness is determined using national databases and patient resource questionnaires at 3 and 6 months post-injury 5. Long-term disability, chronic neuropathic pain and quality of life are determined using the Disability Rating Index (DRI), Neuropathic Pain 4 Questions (DN4) and EuroQol (EQ-5D-5L) respectively at 1, 2, 3, 4 and 5 years post-injury Previous secondary outcome measures: 1. Disability and quality of life are measured using the Disability Rating Index and the EQ-5D-5L at baseline (retrospective) and 3 and 6 months post-injury 2. Wound healing is measured using a validated patient reported questionnaire at 30 days, 3 and 6 months post-injury 3. Number and nature of further surgical interventions is assessed using patients medical records and patient self-report at 30 days, 3 and 6 months 4. Cost effectiveness is determined using national databases and patient resource questionnaires at 3 and 6 months post-injury 5. Long-term disability and quality of life is determined using the Disability Rating Index at 1, 2, 3, 4 and 5 years post-injury	—

Measure

Time frame

Current secondary outcome measures (as of 18/12/2017): 1. Disability and quality of life are measured using the Disability Rating Index and the EQ-5D-5L at baseline (retrospective) and 3 and 6 months post-injury 2. Wound healing is measured using a validated patient reported questionnaire at 30 days, 3 and 6 months post-injury 3. Number and nature of further surgical interventions is assessed using patients medical records and patient self-report at 30 days, 3 and 6 months 4. Cost effectiveness is determined using national databases and patient resource questionnaires at 3 and 6 months post-injury 5. Long-term disability, chronic neuropathic pain and quality of life are determined using the Disability Rating Index (DRI), Neuropathic Pain 4 Questions (DN4) and EuroQol (EQ-5D-5L) respectively at 1, 2, 3, 4 and 5 years post-injury Previous secondary outcome measures: 1. Disability and quality of life are measured using the Disability Rating Index and the EQ-5D-5L at baseline (retrospective) and 3 and 6 months post-injury 2. Wound healing is measured using a validated patient reported questionnaire at 30 days, 3 and 6 months post-injury 3. Number and nature of further surgical interventions is assessed using patients medical records and patient self-report at 30 days, 3 and 6 months 4. Cost effectiveness is determined using national databases and patient resource questionnaires at 3 and 6 months post-injury 5. Long-term disability and quality of life is determined using the Disability Rating Index at 1, 2, 3, 4 and 5 years post-injury

—

Countries

England, United Kingdom, Wales

Outcome results

None listed