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

NCT00866892 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-07-14

No results posted yet for this study

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.

Conditions

  • Facial and Scalp Lacerations

Interventions

PROCEDURE

Irrigation

irrigation

PROCEDURE

No irrigation

no irrigation

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Principal Investigators

  • Jeffrey Louie, MD · Children's Hospitals and Clinics of Minnesota

  • Russell Grimsby, RN · Children's Hospitals and Clinics of Minnesota

  • Michael Oakes, PhD · University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00866892 on ClinicalTrials.gov