NCT02704897

Brief Summary

This study aims to evaluate if a smartphone-delivered tool can help assess for wound infections, and if this improves access to care and results in earlier treatment. Participants will be randomised to one of two groups. The intervention group will receive the smartphone-delivered wound assessment tool (SWAT), to access if they have concerns about their wound. The trial period is 30 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
492

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 14, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

4.4 years

First QC Date

March 2, 2016

Last Update Submit

May 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time from surgery to treatment for surgical site infection

    Measured in days from surgery to commencing antibiotic treatment

    Outcome assessed at 30 day follow-up

Secondary Outcomes (2)

  • Service Usage

    Assessed at 30 day follow-up

  • Access to Services

    Assessed at 30 day follow-up

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Wound assessment tool - delivered via a smartphone. A link will be sent to participants on discharge, which can be accessed at any point should they have concerns about their wound. They will also be sent the tool at 3 additional time-points.

Other: Wound Assessment Tool

Control Arm

NO INTERVENTION

Normal Post-operative Care

Interventions

A set of questions relating to the symptoms of wound infection

Intervention Arm

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency Abdominal Surgery Patients
  • Smartphone Owners
  • Able to give valid consent

You may not qualify if:

  • Significant visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Infirmary Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Related Publications (1)

  • McLean KA, Mountain KE, Shaw CA, Drake TM, Ots R, Knight SR, Fairfield CJ, Sgro A, Skipworth RJE, Wigmore SJ, Potter MA, Harrison EM. Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients. BMJ Open. 2019 Oct 3;9(10):e029620. doi: 10.1136/bmjopen-2019-029620.

Related Links

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ewen Harrison, BM CHB

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 10, 2016

Study Start

June 14, 2016

Primary Completion

October 20, 2020

Study Completion

November 20, 2020

Last Updated

May 23, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations