Clinical Trials Logo

Clinical Trial Summary

This is a implementation research study of a surgical wound tele-monitoring online tool developed at the University of Edinburgh and demonstrated in the "Tracking wound infection with smartphone technology" (TWIST) randomised control trial (NCT02704897) conducted in NHS Lothian. The study design is based on the Medical Research Council (MRC) "Guidance for developing and evaluating complex interventions".

Clinical Trial Description

Surgical site infection (SSI) is one of the most common complications following surgery with significant costs to patients and health systems. Earlier diagnosis and treatment of SSI can reduce its impact. We have previously developed a unique remote wound surveillance tool in a University of Edinburgh research setting. We have demonstrated in a previous randomised controlled trial (NCT02704897), that wound infection can be diagnosed sooner (in the first 7 days postoperatively) when this tool is used. This 12-month implementation research study will be conducted across the general surgical departments of the Royal Infirmary of Edinburgh and the Western General Hospital (two large tertiary hospitals). Informed consent will be required from all patients prior to enrolment, with a target of 200 patients recruited. All data during the study will be collected via online forms hosted on the ISLA care platform, self-submitted by patients based on their own concerns with their wound or prompted by a routine request to complete. These forms are based on the smartphone-delivered wound assessment model developed and delivered in the TWIST trial (based on the Center for Disease Control and Prevention (CDC) classification criteria, and the ASEPSIS model (Additional treatment, Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of Inpatient Stay)). Participants will be asked to upload at least one photograph of their wound each time they use the smartphone-delivered wound assessment tool. Participants will be sent one (1) reminder notification the following day if they have not completed a requested response. On postoperative day 30-day, patients will be requested to complete an online questionnaire based on two validated questionnaires: Bluebelle Wound Healing Questionnaire (WHQ) and Telehealth Usability Questionnaire. Furthermore, a subset of patients will be asked to indicate their interest to take part in a separate semi-structured interview regarding their experience within the study, and views of telemedicine in routine postoperative care (target 20 patients). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05069103
Study type Interventional
Source University of Edinburgh
Contact Ewen M Harrison, MBChB, PhD
Phone 01312423614
Email [email protected]
Status Recruiting
Phase N/A
Start date July 5, 2021
Completion date July 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04096885 - The Inselspital Surgical Cohort Study
Terminated NCT03820648 - Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy N/A
Terminated NCT04042077 - Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections Phase 3
Not yet recruiting NCT05027763 - Effect of Preoperative Diet on Perioperative Gut Microbiome N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Terminated NCT01789697 - Text Message Study N/A
Completed NCT01648088 - Detection of Staph Colonization in Pre-op Arthroplasty Patients N/A
Recruiting NCT05077592 - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections Phase 4
Not yet recruiting NCT04401553 - Prophylactic Antibiotics for Surgical Site Infections and Beta-Lactam Allergy Phase 4
Recruiting NCT03221023 - Intrawound Vancomycin Prophylaxis for Neural Stimulator Phase 2/Phase 3
Completed NCT03257202 - Topical Treatment and Prevalence of P. Acnes Phase 2
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Not yet recruiting NCT04496180 - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy N/A
Not yet recruiting NCT04725916 - Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study) N/A
Recruiting NCT04676841 - Wound Contamination During Orthopaedic Surgery
Recruiting NCT03483363 - Topical Antibiotic Irrigation (Bacitracin) in Prophylaxis of Midfacial Fracture Surgical Wounds New Title Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds Phase 4
Recruiting NCT04548661 - Clinical Evaluation of Adults Undergoing Elective Surgery Utilizing Intraoperative Incisional Wound Irrigation N/A
Terminated NCT03423147 - Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor Phase 2
Completed NCT02578771 - Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle Phase 3