Early Detection of Surgical Wound Infections Using Sensor Technology

NCT03401658 | Withdrawn

• 1 other identifier: 1175
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Infections that are caused by surgical incision are commonly known as surgical site infections (SSI). A surgical wound infection can develop at any time after surgery until the wound has healed (usually two to three weeks after the operation). Very occasionally, an infection can occur several months after an operation. About 5 in 100 patients develop SSI after hospital discharge. During the patient's stay in hospital, nurses routinely change their wound dressings to check for any signs of infection. However, since infections develop after patients leave hospital it is difficult for staff to monitor signs in patients' homes. In some hospitals, staff may contact patients in their homes to check on their wounds but most of the time it is not possible. The recent improvement in surgical operations means that more patients are discharged from hospital earlier than they would have been in the past even before their wounds are healed. Increasingly, patients develop SSI after leaving hospital particularly among the more vulnerable high risk groups. Signs of SSI may not always be recognised by the patient and delays in seeking care leads to serious infection-related complications. The investigators wish to fit a device onto the patients' personal mobile phone camera lens. This will allow patients to take pictures of their wound routinely at home submit images automatically to a computer at the hospital for analysis. Staff at the hospital will alert the patient if the results strongly that indicate signs of infection and an appropriate treatment plan put into place for you. This type of technology has never been used in this application before so, the investigators plan in this study to find out whether it can accurately detect early signs of wound infections and whether it is easy to use, acceptable to the patient and their health care professionals. A total of 40 patients will be invited to take part in the study over a period of 12 months.

Conditions

Surgical Wound Infection; Heart; Surgery, Heart, Functional Disturbance as Result

Outcome Measures

Primary Outcomes (1)

• Number of surgical site infections that can reliably be detected using the sensor technology

  Number of surgical sites infections detected

  Daily for 30 days

Secondary Outcomes (1)

• Proportion of patients that find the sensor technology acceptable

  Questionnaire administered once at day 30

Interventions

Sensor light detector DEVICE

The intervention is based on a sensor technology that gathers data and transmit it to another location for processing. The monitoring utilises an LED light source, an integral detector set which has variance from device to device and chromatic based algorithms for extraction of information from the detectors. The integration of these components into a system provides robustness and stability for operation. The availability of smartphones which possess high quality cameras and constant internet connectivity provides an ideal platform for multimedia clinical data collection and real-time patient-provider communication.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients identified from the surgical waiting or operation list. Patients should be resident within the Liverpool area and must be smartphone users. The mobile phone must have the facility to be locked by either a code or fingerprint recognition. Only high-risk patients that meet the inclusion criteria will be approached for consent, by the consultant performing the initial assessment before the procedure or the research nurse, either in the pre admission clinic or in hospital.

You may qualify if:

• Patients will be included if they had a planned or urgent elective coronary artery bypass graft surgery, 18 years or older, with high risk factors such as elderly patients (≥75 years old) living alone, having morbid obesity (BMI\>37 kg/m2), diabetes, COPD, are smokers or have a planned bilateral harvest of the internal thoracic artery.

You may not qualify if:

• Patients will be excluded if they are: undergoing additional procedures such as antimicrobial-impregnated incision drapes; have existing wound dressing prior to discharge, undergoing chemotherapy, immunosuppressive therapy or steroids; use of antibiotics for an active infection; therapeutic radiation or renal dialysis; intra-aortic balloon pump or mechanical assist device preoperatively. They will be excluded if they have an abnormal skin condition around the surgical incision site; have neutropenia, have HIV infection with CD4 count \<350 per mm3; have sensitivity or allergic to cyanoacrylate, isopropyl alcohol, iodine, iodine-containing products or tape.

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• University of Liverpool: collaborator

Study Sites (1)

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

Related Publications (3)

• Gibson A, Tevis S, Kennedy G. Readmission after delayed diagnosis of surgical site infection: a focus on prevention using the American College of Surgeons National Surgical Quality Improvement Program. Am J Surg. 2014 Jun;207(6):832-9. doi: 10.1016/j.amjsurg.2013.05.017. Epub 2013 Oct 10.

  PMID: 24119885 BACKGROUND

• Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.

  PMID: 12603990 BACKGROUND

• Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.

  PMID: 18538699 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Field, MBBS, PhD

  Liverpool Heart & Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: April 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)