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Postoperative Wound InfectionNCT01691352

Wick vs. No Wick: Does Method of Closure Affect Rate of Wound Infection?

A study testing Wick dressing and No Wick in people with Postoperative Wound Infection, run by Children's Healthcare of Atlanta at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 1 day to 18 years
Conditions the study is for
Postoperative Wound Infection
What is being tested?
Wick dressing and No Wick
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2012to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • All patients at Children's Healthcare of Atlanta (Egleston or Scotish Rite campus) who are scheduled to undergo an ostomy reversal will be approached for participation in this study. As there truly is no known "better" dressing for this type of wound, all patients, including those with co-morbidities such as immunosuppression will be eligible for inclusion in this study. Only those whose families consent to be included in the study will be included or randomized to the study.

Who cannot join

  • Patients who do not give consent to participate will be excluded from this study. Additionally, if at the time of the operation, the surgeon feels that it is not in the patient's best interest to be randomized and included in the study, he/she may decide to exclude the patient.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Healthcare of Atlanta at Egleston

    Atlanta, Georgia, 30022

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Wick dressing, No Wick
Keywords
Wound infection, Ostomy reversal
Medical subject headings
Surgical Wound Infection, Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wick dressingProcedure or surgery

    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

  • No WickProcedure or surgery

    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

Study groups in NCT01691352
Study groupRoleWhat they receive
WickActive comparatorPatients with wick placed in their wound at the time of ostomy reversal
Receives: Procedure: Wick dressing
No wickSham comparatorpatients with non-wicked dressing placed on their wound
Receives: Procedure: No Wick

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound infection

    We will be evaluating wound infection rate, as determined by spreading redness, draining pus, fever, increased wound tenderness in the perioperative period.

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Why it stopped: lack of sufficient population for recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01691352
Sponsor's protocol ID
Stoma Closure_Wound Infection
Status last verified
Dec 2014
First submitted
20 Sep 2012
Last updated
17 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Wick dressing and No Wick in people with Postoperative Wound Infection, run by Children's Healthcare of Atlanta at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound infection (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014; AzTrials last refreshed its copy on 29 Oct 2026.

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