Negative pressure wound therapy for surgical wounds of the foot and ankle

Rationale: By applying prophylactic Negative Pressure Wound Therapy (NPWT) to
patients undergoing surgery to the foot and/or ankle a reduction in the amount
of postoperative woundsurgical site infections will be achieved.

Objective: The aim of this study to To determine the feasibility effect of
using prophylactic NPWT in patients undergoing surgery to the foot and/or ankle.

Study design: The study will be a sSingle-center feasibility intervention
study.

Study population: The study population will consist of pPatients * 18 and *80
years undergoing foot and ankle surgery.

Intervention (if applicable): The intervention groupAll patients will receive
NPWT directly following surgery for at least one week. Longer NPWT can be
applied when necessary.

Main study parameters/endpoints: The main study parameterend point is the
amount of surgical site infections. These will be diagnosed and classified
trough the US Center for Disease and Control and Prevention (CDC) criteria.

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Surgery to foot and/or ankle is associated with
high complication rates. A well-known treatment of these complications such as
surgical site infections is NPWT. We would like to investigate the feasibility
effect of applying prophylactic NPWT to patients undergoing surgery to foot
and/or ankle. By doing so we hope to reduce the amount of complications
following surgery and improve outcome.

Future perspective: If NPWT turns out to be effectivefeasible in this study
population, the results will be used to set up a randomized controlled trial on
prophylactic use of prophylactic NPWT in foot and ankle surgery.

Primary Objective: The primary objective of this study tTo determine the
feasibility ofreduce the amount of surgical site infections using prophylactic
NPWT in patients undergoing surgery to the foot and/or ankle. The NPWT device
which we will use for this pilot has not been used in foot/ankle surgery yet.
We therefore aim to test this new wearable device prior to a RCT.

Secondary Objectives: Secondary objective are (1) To improve functional
outcometo reduce the amount of post-operative wound infections following foot
and ankle surgery; (2) to reduce the amount of pain post-operatively (3) to
regain maximum range of motion earlier compared to the current standard therapy
and (4) to reduce the amount of costs associated with post-operative
woundsurgical site infections following foot and ankle surgery by applying
negative pressure wound therapy to closed incisionsand (5) improve quality of
life by foregoing surgical site infections.

single-center, intervention study

(1) prophylactic application of a NPWT device

Patient risks in this study are minimal and acceptable as negative pressure
wound therapy is a concept which has been studied extensively before. In these
studies a beneficial effect of NPWT over regular wound dressings has been
shown.