Pediatric Pilot Study: Irrigation and Scrubbing in Facial and Scalp Wounds

This study has been withdrawn prior to enrollment.
(PI left the institution)
Sponsor:
Information provided by:
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT00866892
First received: March 19, 2009
Last updated: May 24, 2010
Last verified: May 2010
  Purpose

Most pediatric lacerations occur indoors and are considerably noncontaminated. Wounds that occur outside of the house where dirt often enters the laceration, irrigation and scrubbing with soap has been proven effective at decreasing post-laceration infections. To date there are no pediatric prospective studies addressing a less aggressive approach to face and scalp wound preparation in pediatrics. We argue that wiping wounds with sterile gauze soaked in sterile saline will not increase infection rates as compared to our current practice. In our emergency departments, the current standard of care for all lacerations is aggressive wound preparation: irrigation and scrubbing. This occurs regardless if the wound is contaminated or not. Research has proven that irrigation and scrubbing is unwarranted in adults with face and scalp lacerations. We want to perform a pilot/feasibility study comparing our two emergency campuses. One campus will serve as the control site, while the other will be the intervention site. In this pilot study, our goal is to demonstrate the feasibility of the intervention and provide data that a less aggressive approach to wound preparation is just as effective as our standard of care. We hope this project leads to further discussion about how we manage noncontaminated lacerations and provides a stepping-stone to a larger, appropriated powered study.


Condition Intervention
Facial and Scalp Lacerations
Procedure: Irrigation
Procedure: No irrigation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Noncontaminated Facial and Scalp Wounds in the Pediatric Population: Getting Away Without Irrigation and Scrubbing

Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Our specific aim is to provide evidence that using a less aggressive approach to wound preparation in a selective population will be as effective as our current practice. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Our secondary goals are to involve nurses in a prospective interventional study, document the feasibility of the study, and demonstrate patient satisfaction with our suture outcomes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: irrigation Procedure: Irrigation
irrigation
Experimental: no irrigation Procedure: No irrigation
no irrigation

  Eligibility

Ages Eligible for Study:   1 Month to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. facial and scalp wounds acquired by blunt trauma,
  2. wounds incurring within a house or indoor gym,
  3. all ages, 1 month to 20 years of age.

Scalp is defined as the skin covering the head. The face is the area anterior to the ears, below the chin and extending to the hairline of the forehead. Wounds requiring deep sutures will also be included.

Exclusion Criteria:

  1. Patients presenting with wounds that occur outdoors,
  2. Wounds greater than 12 hour old,
  3. Immunocompromised, malnourished or a diabetic,
  4. Intoxicated,
  5. Currently on antibiotics,
  6. Sickle cell anemia,
  7. Collagen vascular disease,
  8. Wounds requiring plastic surgery,
  9. Wounds from human or animal bites,
  10. Wounds not on the face or scalp,
  11. Patient's just discharged from the hospital within 72 hours,
  12. Wounds with foreign bodies or grossly contaminated,
  13. No suture nurses are present or available to suture.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866892

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
St. Paul and Minneapolis, Minnesota, United States
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Jeffrey Louie, MD Children's Hospitals and Clinics of Minnesota
Principal Investigator: Russell Grimsby, RN Children's Hospitals and Clinics of Minnesota
Principal Investigator: Michael Oakes, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:

Responsible Party: Jeffrey Louie, MD, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT00866892     History of Changes
Other Study ID Numbers: 0808-081
Study First Received: March 19, 2009
Last Updated: May 24, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Facies
Lacerations
Disease Attributes
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014