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

NCT ID: NCT00866892

Last Updated: 2015-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Facial and Scalp Lacerations

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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irrigation

Group Type ACTIVE_COMPARATOR

Irrigation

Intervention Type PROCEDURE

irrigation

no irrigation

Group Type EXPERIMENTAL

No irrigation

Intervention Type PROCEDURE

no irrigation

Interventions

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Irrigation

irrigation

Intervention Type PROCEDURE

No irrigation

no irrigation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Children's Hospitals and Clinics of Minnesota

Principal Investigators

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Jeffrey Louie, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospitals and Clinics of Minnesota

Russell Grimsby, RN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospitals and Clinics of Minnesota

Michael Oakes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Children's Hospitals and Clinics of Minnesota

Saint Paul and Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Stussman BJ. National Hospital Ambulatory Medical Care Survey: 1994 emergency department summary. Adv Data. 1996 May 17;(275):1-20. No abstract available.

Reference Type BACKGROUND
PMID: 10162000 (View on PubMed)

Hollander JE, Singer AJ, Valentine S, Henry MC. Wound registry: development and validation. Ann Emerg Med. 1995 May;25(5):675-85. doi: 10.1016/s0196-0644(95)70183-4.

Reference Type BACKGROUND
PMID: 7741347 (View on PubMed)

Islam S, Ansell M, Mellor TK, Hoffman GR. A prospective study into the demographics and treatment of paediatric facial lacerations. Pediatr Surg Int. 2006 Oct;22(10):797-802. doi: 10.1007/s00383-006-1768-7. Epub 2006 Sep 1.

Reference Type BACKGROUND
PMID: 16947027 (View on PubMed)

Baker MD, Lanuti M. The management and outcome of lacerations in urban children. Ann Emerg Med. 1990 Sep;19(9):1001-5. doi: 10.1016/s0196-0644(05)82563-6.

Reference Type BACKGROUND
PMID: 2393165 (View on PubMed)

Sagerman PJ. Wounds. Pediatr Rev. 2005 Feb;26(2):43-9. doi: 10.1542/pir.26-2-43. No abstract available.

Reference Type BACKGROUND
PMID: 15687474 (View on PubMed)

Krizek TJ, Davis JH. Endogenous wound infection. J Trauma. 1966 Mar;6(2):239-48. No abstract available.

Reference Type BACKGROUND
PMID: 5908175 (View on PubMed)

Haury B, Rodeheaver G, Vensko J, Edgerton MT, Edlich RF. Debridement: an essential component of traumatic wound care. Am J Surg. 1978 Feb;135(2):238-42. doi: 10.1016/0002-9610(78)90108-3.

Reference Type BACKGROUND
PMID: 626301 (View on PubMed)

Hollander JE, Singer AJ, Valentine S. Comparison of wound care practices in pediatric and adult lacerations repaired in the emergency department. Pediatr Emerg Care. 1998 Feb;14(1):15-8. doi: 10.1097/00006565-199802000-00004.

Reference Type BACKGROUND
PMID: 9516624 (View on PubMed)

Valente JH, Forti RJ, Freundlich LF, Zandieh SO, Crain EF. Wound irrigation in children: saline solution or tap water? Ann Emerg Med. 2003 May;41(5):609-16. doi: 10.1067/mem.2003.137.

Reference Type BACKGROUND
PMID: 12712026 (View on PubMed)

Hollander JE, Richman PB, Werblud M, Miller T, Huggler J, Singer AJ. Irrigation in facial and scalp lacerations: does it alter outcome? Ann Emerg Med. 1998 Jan;31(1):73-7. doi: 10.1016/s0196-0644(98)70284-7.

Reference Type BACKGROUND
PMID: 9437345 (View on PubMed)

Other Identifiers

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0808-081

Identifier Type: -

Identifier Source: org_study_id

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