Postoperative Wound Infection Clinical Trial
Official title:
Prospective, Randomized Controlled Trial of Wound Management After Ostomy Closure
Countless children undergo surgery annually for management of what clinicians consider to be a "dirty wound". One frequently encountered example is the ostomy reversal. During this planned operation, the previously diverted small bowel or colon is reconnected with the distal intestine, restoring continuity. However, this procedure leaves an open wound on the anterior abdominal wall, creating a conundrum for the surgeon and raises the question: how should the wound be managed? In the investigators practice at CHOA, surgeons utilize both a wick and a non-wicked wound dressing. In this prospective randomized trial, we wish to evaluate these two dressings in children receiving an ostomy closure. The investigators hypothesis is that the incidence of wound infection after ostomy reversal is the same regardless of if a wick is placed or not.
Countless children undergo surgery annually for management of what clinicians consider to be
a "dirty wound". These include any case where the patient has a known intraabdominal
infection or enteric contents are likely to have contaminated the surgical field. One
frequently encountered example is the ostomy reversal. During this planned operation, the
previously diverted small bowel or colon is reconnected with the distal intestine, restoring
continuity. However, this procedure leaves an open wound on the anterior abdominal wall,
creating a conundrum for the surgeon and raises the question: how should the wound be
managed?
Historically, surgeons would close the ostomy site in a primary fashion using a running
subcuticular suture. While there is no "national standard" for wound closure of ostomies,
concern over the likelihood of local wound infection has led most modern day practitioners
to leave the wound open to drain in some fashion. Still the techniques used varies from the
use of simple interrupted sutures along the wound incision to the use of a betadine soaked
gauze "wick" in the wound. Other surgeons have attempted to close ostomy sites in a delayed
fashion, 48-72 hours after the primary operation.
Limited research has been prospectively performed to evaluate and compare the merit of these
techniques. In children, there has been no recent data directly addressing this question.
In our practice at CHOA, surgeons utilize both a wick and a non-wicked wound dressing. Our
current wound infection rate is approximately 10%, defined as spreading redness, draining
pus, fever, increased wound tenderness in the perioperative period. Unfortunately, the type
of dressing placed at the end of an operation is rarely, if ever documented in an operative
note, therefore a retrospective review to assess outcomes is not feasible. While there is no
exact statistics for how many ostomies were closed using a wick versus an non-wicked
dressing, in a survey of our 7 physicians, approximately 50% of the attending report that
they place a wick on all of their patients and the remaining attendings do not use a wick
with the rare exception of a particularly "dirty wound" (i.e. significant spillage of stool
into the wound or grossly necrotic/infected tissue) or a particularly deep wound. Clinicians
who elect to use a wick have adopted that practice based on person opinion that it allows
the wounds to drain better, thus preventing infection. Those who do not place a wick state
that they feel it is an unnecessary step in the dressing and that interrupted sutures alone
are sufficient to allow the wound to drain.
After a lengthy discussion with all of the surgeons at Egleston and 4 of the surgeons at
Scottish Rite, as a department, we have decided to evaluate the type of dressing used for
ostomy closure in order to see if there is in fact any benefit to leaving a wick in the
ostomy wound. All of the surgeons have agreed to participate in this study without undo
bias.
In this prospective randomized trial, we wish to evaluate these two dressings in children
receiving an ostomy closure. Our hypothesis is that the incidence of wound infection after
ostomy reversal is the same regardless of if a wick is placed or not.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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