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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Children's Healthcare of Atlanta
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT01691352
First received: September 20, 2012
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Postoperative Wound Infection
Procedure: Wick dressing
Procedure: No Wick

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Controlled Trial of Wound Management After Ostomy Closure

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Primary Outcome Measures:
  • Wound infection [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    We will be evaluating wound infection rate, as determined by spreading redness, draining pus, fever, increased wound tenderness in the perioperative period.


Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Wick
Patients with wick placed in their wound at the time of ostomy reversal
Procedure: Wick dressing
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
Sham Comparator: No wick
patients with non-wicked dressing placed on their wound
Procedure: No Wick
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

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691352

Contacts
Contact: Matthew Clifton, MD 404.785.0781 mclifto@emory.edu
Contact: Sarah J Hill, MD 404.785.0781 shill9@emory.edu

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston Recruiting
Atlanta, Georgia, United States, 30022
Contact: Sarah Hill, MD    404-785-0781    shill9@emory.edu   
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Matthew Clifton, MD Faculty Surgeon
  More Information

No publications provided

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT01691352     History of Changes
Other Study ID Numbers: Stoma Closure_Wound Infection
Study First Received: September 20, 2012
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
Wound infection
Ostomy reversal

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014