Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Children's Hospitals and Clinics of Minnesota |
---|---|
Information provided by: | Children's Hospitals and Clinics of Minnesota |
ClinicalTrials.gov Identifier: | NCT00866892 |
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: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | A Pilot Study of Noncontaminated Facial and Scalp Wounds in the Pediatric Population: Getting Away Without Irrigation and Scrubbing |
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 |
---|---|
irrigation: Active Comparator |
Procedure: Irrigation
irrigation
|
no irrigation: Experimental |
Procedure: No irrigation
no irrigation
|
Ages Eligible for Study: | 1 Month to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Contact: Laurie Blumberg-Romero | 612-813-7628 | laurie.blumberg-romero@childrensmn.org |
United States, Minnesota | |
Children's Hospitals and Clinics of Minnesota | |
St. Paul and Minneapolis, Minnesota, United States |
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 |
Responsible Party: | Children's Hospitals and Clinics of Minnesota ( Jeffrey Louie, MD ) |
Study ID Numbers: | 0808-081 |
Study First Received: | March 19, 2009 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00866892 History of Changes |
Health Authority: | United States: Institutional Review Board |
Lacerations Facies Wounds and Injuries Disorders of Environmental Origin |
Lacerations Disease Attributes Pathologic Processes |
Facies Wounds and Injuries Disorders of Environmental Origin |