Pecan Study:
Pilot and explorative study comparing the effects of a capillary dressing to negative pressure wound therapy

With an incidence of 1.5 * 20 % in European countries, surgical site infections
(SSI) are a frequent problem leading to significant wound dehiscences,
morbidity and mortality. Despite the lack of adequately powered RCTs, in many
clinics Negative Pressure Wound Therapy (NPWT) is the first choice of treatment
on surgical wounds healing by second intention. Thereby, the success of NPWT is
not only determined by its efficacy, but also by its impact on the patients*
quality of life (QoL). It is suggested that a new available capillary dressing
is a valuable alternative to NPWT in terms of better tolerance by the patient
with wounds healing by secondary intention due to SSI and comparable time to
achieve complete wound healing. Up to now, studies have mainly compared the
effectiveness of NPWT with Standard Wound Care (SWC; i.e. no capillary
dressing). Therefore, we propose conducting this pilot study to compare time to
complete wound healing and experienced QoL between NPWT and a capillary
dressing and with SWC. We aim to establish the feasibility of conducting a
definitive randomised controlled trial (RCT) comparing the effectiveness of
this capillary dressing with NPWT and with SWC.

Therefore, we propose conducting this pilot study to compare time to complete
wound healing and experienced QoL between NPWT and a capillary dressing and
with SWC. We aim to establish the feasibility of conducting a definitive
randomised controlled trial (RCT) comparing the effectiveness of this capillary
dressing with NPWT and with SWC.

A multicenter, randomized pilot study. Patients will be randomized to one of
the three treatment arms: (1) a capillary dressing (Vacutex* ); (2) NPWT; and
(3) SWC.

A capillary dressing (i.e., Vacutex*) will be compared with a commercially
available NPWT and standard wound care (defined as dressings providing a moist
wound environment which are routinely used in the participating hospital site).

Participants will be asked to fill in an EQ-5D-5L questionnaire at baseline
(day of inclusion), after one week and when the wound has healed,
taking up 15 minutes in total. Furthermore, patients will be asked to take
photos (or let the (home care) nurse take photos) of their wound at baseline,
when granulation tissue has reached skin level and when complete wound healing
has been achieved. Additionally, patients will be asked to score on a Visual
Analogue Scale (VAS) the experienced pain and itch, daily and during dressing
changes.
NPWT and capillary dressings are both commonly used wound treatments nowadays.
Although many patients have benefited from NPWT, adverse events*including
deaths and serious injuries*have been reported to the FDA.[1] The most serious
adverse events associated with NPWT, blood loss and infection, can be prevented
if healthcare professionals pay close attention to criteria for patient
selection, instructions for use and appropriate care setting.[1] Nevertheless,
NPWT has been shown to be a safe intervention in several systematic reviews,
where the risks described above were not designated to be a problem. No adverse
events of Vacutex* are described.