A Mobile-Health application for follow-up treatment of primary closed wounds in an outpatient setting -
A randomized controlled trial

Post-discharge follow-up visits after primary closure of uncomplicated wounds
account for a substantial amount of hospital and general practitioner visits. A
well-guided mobile health system providing tailor-made advices and instructions
to patients on how to take care of their surgical wound and remove sutures at
home may improve the quality of care, provide greater comfort for patients,
more effectiveness for practitioners and reduce the burden on the health care
system.

The objective of this study is four-fold:
1)To investigate the safety and effectiveness of a mobile-health system
intended to promote wound monitoring and sutures removal of primary closed
uncomplicated wounds by the patients at home. The system is based on a "store
and forward" mobile health application allowing patients to send data to their
doctor and allowing healthcare professionals to evaluate the outcomes of the
wound healing and of the sutures removal remotely;
2) To investigate if the number of visits to the hospital and/or general
practitioner is significantly lower for patients attempting sutures removal at
home if proper instructions are given via a mobile health application and if
confirmation of successful wound healing is given by a healthcare professional
remotely;
3) To assess patients' and caregiver*s satisfaction regarding the use of the
mobile health system.
4) To assess possible economic benefits through analyzing the amount of time
caregivers are spending on usage of the mobile application system compared to
the current standard of care.

Randomized controlled clinical study

The investigational group uses a mobile health application intended to promote
self-care and suture removal for primary closed uncomplicated wounds at home.
The control group follows the standard procedure with oral and written
instructions for wound care and a follow-up visit at the care-giver.

Study duration: 12 months. Participants will receive no personal monetary
benefits. The application is uncomplicated and will be within the manageable
load to participants.

The subjects in the study are adult volunteers in good health, considered to be
at low risk of complications after surgery and in possession of a
camera-equipped smartphone with a sufficient quality.

The in- and exclusion criteria as well as the open design of the study (in
which patients can spontaneously decide to follow the standard treatment if
they feel uncomfortable to remove their sutures at home) are designed to select
low risk patients that are confident to handle the follow up of a small
superficial procedure themselves. If patients suspect to suffer from
complications, such as wound infection or wound dehiscence, they will be asked
to admit themselves to the outpatient clinic of the Catharina hospital
Eindhoven or during out of office hours to the emergency room where they will
be seen by the doctor on call from the dermatology department.

This procedure is not different from the current clinical standard in the
Netherlands and does not cause an additional risk to the participants in the
study. In case of wound infections, the majority can be treated with a simple
regimen of antibiotics.