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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 3 July 2017
Main ID:  ISRCTN55305726
Date of registration: 31/05/2017
Prospective Registration: Yes
Primary sponsor: University of Oxford
Public title: WHITE 7 - WHISH – Wound Healing in Surgery for Hip fractures
Scientific title: A randomised controlled feasibility trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures
Date of first enrolment: 15/06/2017
Target sample size: 464
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN55305726
Study type:  Interventional
Study design:  Randomised; Interventional; Design type: Treatment, Device, Surgery (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name: James    Masters
Address:  Kadoorie Centre, Level 3 John Radcliffe Hospital Headley Way OX3 9DU Oxford United Kingdom
Telephone: +44 1865 223114
Email: WHISH@ndorms.ox.ac.uk
Affiliation: 
Name: Lucy    Sansom
Address:  University of Oxford OX3 7LE Oxford United Kingdom
Telephone: +44 1865 227903
Email: lucy.sansom@ndorms.ox.ac.uk
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients aged 65 years or older
2. Patients that have a hip fracture requiring surgical treatment

Exclusion criteria: Patients having percutaneous screw fixation of an undisplaced intracapsular fracture of the hip.

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the hip and thigh, Infection/ Other infectious diseases
Musculoskeletal Diseases
Hip fracture requiring surgical treatment
Intervention(s)
Patients with a fracture of the hip will present at the trial centres to undergo surgery on the next planned trauma operating list. At the end of their surgery they will be randomised to one of two groups via the use of a centralised computer randomisation service RRAMP (https://rramp.octru.ox.ac.uk) provided by the Oxford Clinical Trials Research Unit (OCTRU). Randomisation will be stratified by centre to ensure the participants from each study site have an equal chance of receiving each intervention.

Group 1: Participants have the standard wound dressing applied after closure of the wound during surgery as per local hospital procedures.

Group 2: Participants receive a negative pressure wound therapy (NPWT) dressing. The NPWT dressing uses an ‘open-cell’, solid foam which is laid onto the wound as an intrinsic part of a sealed dressing. A sealed tube connects the dressing to a built in mini-pump which creates a partial vacuum over the wound.

In most cases the first dressing applied to the wound at the end of the operation is left in place until the wound is ready for the stitches to be removed which is usually one to two weeks after the surgery. However, in some cases, depending upon the specific injury and according to the treating surgeons’ normal practice, the wound may be re-dressed again on the ward. Any further wound dressing will be recorded and will follow the allocated treatment unless otherwise clinically indicated.

Participants are assessed to see whether they develop an infection as well as the routine questions that are asked of all people who break their hip.
Primary Outcome(s)
Deep Infection, using the Center 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 within 30 days post surgery
Secondary Outcome(s)
1. Rate of Mortality
2. Health-related quality of life is measured using the EuroQol EQ-5D-5L questionnaire at baseline and 4 months post-surgery
3. Complications and surgical interventions related to the index wound are measured using questionnaires at 4 months
4. Cost consequences and resource use (NHS costs, patient's out-of-pocket expenses) are measured using a short questionnaire at four months post injury
5. Mobility is measured using questionnaires at the baseline and 4 month CRF
6. Residential status is measured using questionnaire at baseline and at 4 months
7. Recruitment rate is measured using questionnaire at baseline
8. Retention rate is measured using screening logs at baseline

The core outcome set available via [http://www.comet-initiative.org/studies/details/274] has been consulted in the construction of the study outcome measures
Secondary ID(s)
34527
Source(s) of Monetary Support
National Institute for Health Research, Royal College of Surgeons of England
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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