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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01281930
Other study ID # 09-0719 -201103241
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2009
Est. completion date November 2015

Study information

Verified date June 2018
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Abscesses or "boils" are becoming more common every year and are a common reason children come to the Emergency Department. For the abscess to heal the skin needs to be opened to let the pus come out. Often doctors put something called "packing material" or gauze into the abscess space to help aid in healing. It is not known if the type of "packing" that is done is necessary or if a more simple treatment is as good or better. With informed consent we randomly place a child into one (1) of two (2) groups in this study that will say if the child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece) of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment in the emergency department the child will be scheduled to follow-up in the Pediatric Acute Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this visit the healing of the wound will be checked by the staff in the clinic and will be scored. With this evaluation of the wound the hypothesis that for a simple superficial (skin) abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of traditional gauze packing.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria:

- Well appearing patient

- Abscesses restricted to the superficial areas of the extremities, buttocks, abdominal and thoracic walls, and back

- Patients presenting Saturday-Wednesday

Exclusion Criteria:

- Fever >38 degrees celsius

- Ill appearing patient

- Underlying immunodeficiency or disorder leading to chronic abscess formation

- Any reason for admission to hospital beyond the need for sedation at the time of follow-up

- Thursday-Friday

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Full packing into abscess cavity
After incision and drainage plain 1/4-1/2 inch gauze packing material is placed into the cavity to fill it
Wick placement into abscess cavity
After incision and drainage of the abscess a piece of plain gauze 1/4-1 inch packing material that is as wide as can be easily passed through the opening is placed into the cavity spanning one diameter of the cavity

Locations

Country Name City State
United States St. Louis Children's Hospital Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abscess healing based upon clinical criteria and clinical judgement Abscesses are assessed for pus accumulation, erythema from the wound, if the patient has a fever and the overall clinical judgment of the evaluating health care professional at the time of follow-up. 24-72 hours
Secondary Pain since abscess drainage 24-72 hours
Secondary Parent/guardian comfort with removing the packing material or wick from the abscess cavity 24-72 hours
Secondary Parent/guardian assessment of the abscess wound at 2 weeks 2 weeks
Secondary Parent/guardian assessment of pus drainage at 2 weeks 2 weeks
Secondary Need for further treatment of same abscess within 2 weeks 2 weeks