Skip to content

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

A Pilot Study of Noncontaminated Facial and Scalp Wounds in the Pediatric Population: Getting Away Without Irrigation and Scrubbing

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00866892
Enrollment
0
Registered
2009-03-23
Start date
2009-04-30
Completion date
2010-04-30
Last updated
2015-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial and Scalp Lacerations

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.

Interventions

PROCEDUREIrrigation

irrigation

PROCEDURENo irrigation

no irrigation

Sponsors

Children's Hospitals and Clinics of Minnesota
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 20 Years
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.

Design outcomes

Primary

MeasureTime frame
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.12 months

Secondary

MeasureTime frame
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.12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026