WHITE 7 - WHISH – Wound Healing in Surgery for Hip fractures

• Register: ISRCTN
• Last refreshed on: 15 August 2022
• 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: https://www.isrctn.com/ISRCTN55305726
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Treatment, Device, Surgery (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Lucy Sansom

• Name: James Masters

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

Ethics review

Status:
Approval date:
Contact:

Oxford C Research Ethics Committee, 28/04/2017, 17/SC/0207

Results

• Results available: Yes
• Date Completed: 17/08/2018