The study will explore the ability of negative pressure wound therapy (Prevena dressing) to
      reduce post operative superficial surgical site infection rate in elective colorectal
      surgery. Half of the participants will receive Prevena dressing on closed incision
      immediately after the operation while other half will receive conventional surgical dressing.

A Randomized Controlled Trial Exploring the Ability of Negative Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical Site Infections (SSI)

Surgical Wound Infection

The trial will commence with recruitment of participants after an assessment of their
      potential eligibility. Those recruited in the trial will sign informed consent either on the
      day of surgery or during the PAC appointment, before any study-related activities are
      performed.

      Perioperative measures will include bowel preparation with Fleet Phospho-soda, preoperative
      shaving with electric clippers 1 hour before the operation, and intravenous prophylactic
      antibiotic administered 30 minutes before the incision, and repeated in OR if the operation
      lasts more than 3 hours, and discontinued within 24 h after the operation. In all procedures,
      chlorhexidine solution will be applied to the skin to achieve preoperative skin antisepsis,
      and the usual reusable or disposable surgical gowns, drapes, and gloving will be used. The
      type of surgical procedure will be a colorectal resection for any malignant or benign
      condition of the colon, rectum or anal canal via a laparotomy wound. The type of incision
      will either be a vertical midline or transverse abdominal incision. Laparotomy wound will be
      closed primarily as a mass closure technique utilizing polydioxanone (PDS) or Nylon suture.
      Skin and subcutaneous tissues will be approximated using stainless-steel staples.

      During the surgery, assessment of eligibility (including wound classification) will be
      completed, and if eligible, the participant will be randomized to one of the two treatment
      arms - group A (conventional dressing) or group B (Prevena dressing). The randomization
      scheme is described later in the protocol. After the surgical wound is closed, the assigned
      dressing - conventional dressing (Mepore) or Prevena dressing - will be applied.

      For participants in group A (conventional dressing) the wound will be inspected on an as
      needed basis during postoperative days 1-6 to assess for SSI (where day 0 = day of surgery).
      On postoperative day 7, the dressing will be removed. If the participant is in hospital, the
      wound care nurse or study staff will remove the dressing and examine the wound for SSI. If
      the participant was discharged before postoperative day 7, the home care nurse or the
      participant's physician will remove the dressing. The patient will have been sent home with a
      Post-Op Day 7 follow-up form, and will have been instructed to provide the form to the home
      care nurse or their physician to complete for the assessment for SSI.

      For participants randomized to group B (Prevena dressing), the wound care nurse or study
      staff will inspect the dressing daily during postoperative days 1-6 (where day 0 = day of
      surgery) to assess for proper functioning of the Prevena dressing. If the participant is
      discharged before postoperative day 7, the wound care nurse or study staff will contact the
      participant daily to check for proper functioning of the Prevena dressing. On postoperative
      day 7, the Prevena dressing will be removed. If the participant is in hospital, the wound
      care nurse or study staff (residents or Surgeons) will remove the dressing and assess the
      wound for SSI. If the participant was discharged before postoperative day 7, the home care
      nurse or the participant's physician will remove the dressing. The patient will have been
      sent home with a Post-Op Day 7 follow-up form, and will have been instructed to provide the
      form to the home care nurse or their physician to complete for signs of SSI.

      If SSI is suspected, the participant will be advised to visit the clinic for assessment of
      SSI by the study team. In case it is not possible for the participant to visit the clinic for
      assessment of SSI by the study team, the participants will have been sent home with a SSI
      Confirmation form to be completed by the participant's physician.

      The wound care nurse or study staff will conduct post-discharge follow-up on postoperative
      days 14 (± 2 days) and 21 (± 2 days) by telephoning the family physician or the participant
      to check whether there are signs of SSI. If SSI is suspected, the participant will be advised
      to visit the clinic for assessment of SSI by the study team. If not possible, the participant
      will be instructed to ask their physician to complete the SSI Confirmation form.

      On postoperative day 30 (± 7 days), the participant will be seen in the clinic by the
      treating surgeon as a part of the treatment and follow-up plan, and the wound will be
      assessed for SSI. For participants who are not able to come to the clinic, the study team
      will contact the participant or the family physician by telephone to check whether there are
      signs of SSI. If SSI is suspected, the participant will be advised to visit the clinic for
      assessment of SSI by the study team. If not possible, the participant will be instructed to
      ask their physician to complete the SSI Confirmation form.

      As described above, each participant will have up to 12 study visits (11 scheduled visits,
      including the day of surgery, plus one clinic visit if there is suspicion of SSI). At any
      point, however, once SSI is confirmed, the participant will undergo no further study visits.

Prevena Dressing

Primary outcome of interest will be the presence and/or absence of superficial surgical site infection at postoperative day 30.

M.D.

The secondary outcome will be any side effects related to the intervention.

This group will receive prevena dressing after the elective colorectal surgery

This group will receive conventional dressing after the elective colorectal surgery

A Randomized Controlled Trial Exploring the Ability of Negative Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical Site Infections (SSI)

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?