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A non randomised pragmatic trial for the early detection and prevention of surgical wound complications using an advanced hydropolymer wound dressing and smartphone technology; the EDISON study.

A non randomised pragmatic trial for the early detection and prevention of surgical wound complications using an advanced hydroplymer wound dressing and smartphone techonology; the EDISON study.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000004965
Acronym
EDISON
Enrollment
200
Registered
2020-01-08
Start date
2024-01-08
Completion date
2024-09-26
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A safe and common surgical procedure; hip and knee arthroplasty (THA, TKA) is not immune to the occurrence of postoperative complications such as surgical site infection (SSI) or surgical wound dehiscence (SWD). While published rates of SSI following hip or knee arthroplasty are low, 1-2% in some cases, it is the resulting wound complication and its clinical management and the catastrophic impact to the patient’s wound healing and wellbeing and return to daily life that is of considerable concern. Complications such as surgical site infection and/or dehiscence following TKA and THA, often result in extended lengths of stay, readmission for further surgery, primary and community nursing visits, and are a costly burden to healthcare settings. To address the evidence gap for the early identification and prevention of postoperative wound complications in obese patients following hip or knee arthroplasty, a non randomized pragmatic trial is proposed which will utilize an advanced hydropolymer wound dressing coupled with smartphone technology for the early identification of complication and prevention. The advanced wound hydropolymer dressing is transparent and allows for complete visibility of the incision line. This allows the patient to send digital images of their incision line to the clinician who is able determine the healing progress of the participants surgical wound. The use of digital images of the wound sent to the clinician for assessment remotely and without removal of the dressing potentially removes the need for hospital readmission due the ability to diagnose a complication early and intervene. Furthermore, use of this patient engaged model empowers the patient in their wound healing. This study will determine the feasibility of such a model in the post discharge setting to assist in reducing the number of hospital readmission due to surgical wound breakdowns, often diagnosed and treated too late to prevent the escalation to a catastrophic wound breakdown.

Interventions

The participant will have a standard surgical dressing covering their surgical incision after surgery. The dressing is a transparent hydroplymer wound dressing, currently used in clinical practice. The dressing is transparent and allows for complete visibility of wound healing progress whilst leaving the dressing intact. The dressing wear time is 7 days. The patient will have the ability to capture digital images of their incisional wound via their smartphone, while at home, and transmit them t

The participant will have a standard surgical dressing covering their surgical incision after surgery. The dressing is a transparent hydroplymer wound dressing, currently used in clinical practice. The dressing is transparent and allows for complete visibility of wound healing progress whilst leaving the dressing intact. The dressing wear time is 7 days. The patient will have the ability to capture digital images of their incisional wound via their smartphone, while at home, and transmit them to the study clinician for review and early identification of potential wound complications. Photos will be sent daily to the study clinician for review. For monitoring and compliance the participant will be in contact with study personnel every second day to assist with queries or troubleshooting.

Sponsors

University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Consenting male or female adults who are scheduled to undergo an elective hip or knee arthroplasty.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026