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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00866892
Recruitment Status : Withdrawn (PI left the institution)
First Posted : March 23, 2009
Last Update Posted : July 14, 2015
Information provided by:
Children's Hospitals and Clinics of Minnesota

Brief Summary:
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 or disease Intervention/treatment Phase
Facial and Scalp Lacerations Procedure: Irrigation Procedure: No irrigation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: irrigation Procedure: Irrigation
Experimental: no irrigation Procedure: No irrigation
no irrigation

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00866892

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
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

Responsible Party: Jeffrey Louie, MD, Children's Hospitals and Clinics of Minnesota Identifier: NCT00866892     History of Changes
Other Study ID Numbers: 0808-081
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015

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