Sponsor study identifier
interventional
0
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 20, 2012
Actual (reported)September 24, 2012
Actual (reported)June 2014
Actual (reported)June 2014
Actual (reported)Wound infection
We will be evaluating wound infection rate, as determined by spreading redness, draining pus, fever, increased wound tenderness in the perioperative period.
14 days
Patients with wick placed in their wound at the time of ostomy reversal
patients with non-wicked dressing placed on their wound
Once the fascia of the ostomy site is closed, the subcutaneous space will be irrigated with normal saline. The skin will then be reapproximated using an absorbable suture, spaced every 1 cm across the wound (i.e. for a 2cm wound, a single suture will be placed in the middle). A moist, saline/betadine soaked gauze will then be gently packed into the wound spaces, on either side of the sutures. The gauze will be packed into the wound to the depth of ½ a cm, or ½ of the wound depth, whichever is greater. A single dry piece of gauze will then be secured over the top of the wound. Dressings and packing will be removed by the surgical team on post-operative day 2
Contact the study team to confirm eligibility.
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30022, United States
Matthew Clifton, MD
Faculty Surgeon
0 participants (actual enrollment reported by the registry).
First Submitted
September 20, 2012
First Posted
September 24, 2012
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Once the fascia of the ostomy site is closed, the subcutaneous space will be irrigated with normal saline. The skin will then be reapproximated using an absorbable suture, spaced every 1 cm across the wound (i.e. for a 2 cm wound, a single suture will be placed in the middle). A single piece of dry gauze will then be secured over the top of the wound. Dressings will be removed by the surgical team on post-operative day 2
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
December 17, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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