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

Primary Purpose

Facial and Scalp Lacerations

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Irrigation
No irrigation
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial and Scalp Lacerations

Eligibility Criteria

1 Month - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospitals and Clinics of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

irrigation

no irrigation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 19, 2009
Last Updated
July 13, 2015
Sponsor
Children's Hospitals and Clinics of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00866892
Brief Title
Pediatric Pilot Study: Irrigation and Scrubbing in Facial and Scalp Wounds
Official Title
A Pilot Study of Noncontaminated Facial and Scalp Wounds in the Pediatric Population: Getting Away Without Irrigation and Scrubbing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI left the institution
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Hospitals and Clinics of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial and Scalp Lacerations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
irrigation
Arm Type
Active Comparator
Arm Title
no irrigation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Irrigation
Intervention Description
irrigation
Intervention Type
Procedure
Intervention Name(s)
No irrigation
Intervention Description
no irrigation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: facial and scalp wounds acquired by blunt trauma, wounds incurring within a house or indoor gym, 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: Patients presenting with wounds that occur outdoors, Wounds greater than 12 hour old, Immunocompromised, malnourished or a diabetic, Intoxicated, Currently on antibiotics, Sickle cell anemia, Collagen vascular disease, Wounds requiring plastic surgery, Wounds from human or animal bites, Wounds not on the face or scalp, Patient's just discharged from the hospital within 72 hours, Wounds with foreign bodies or grossly contaminated, No suture nurses are present or available to suture.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Louie, MD
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell Grimsby, RN
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Oakes, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
St. Paul and Minneapolis
State/Province
Minnesota
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10162000
Citation
Stussman BJ. National Hospital Ambulatory Medical Care Survey: 1994 emergency department summary. Adv Data. 1996 May 17;(275):1-20. No abstract available.
Results Reference
background
PubMed Identifier
7741347
Citation
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. Erratum In: Ann Emerg Med 1995 Oct;26(4):532.
Results Reference
background
PubMed Identifier
16947027
Citation
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.
Results Reference
background
PubMed Identifier
2393165
Citation
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.
Results Reference
background
PubMed Identifier
15687474
Citation
Sagerman PJ. Wounds. Pediatr Rev. 2005 Feb;26(2):43-9. doi: 10.1542/pir.26-2-43. No abstract available.
Results Reference
background
PubMed Identifier
5908175
Citation
Krizek TJ, Davis JH. Endogenous wound infection. J Trauma. 1966 Mar;6(2):239-48. No abstract available.
Results Reference
background
PubMed Identifier
626301
Citation
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.
Results Reference
background
PubMed Identifier
9516624
Citation
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.
Results Reference
background
PubMed Identifier
12712026
Citation
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.
Results Reference
background
PubMed Identifier
9437345
Citation
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.
Results Reference
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Pediatric Pilot Study: Irrigation and Scrubbing in Facial and Scalp Wounds

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