Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-02 @ 12:45 AM
Study NCT ID:
NCT00866892
Status:
WITHDRAWN
Last Update Posted:
2015-07-14
First Post:
2009-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Pilot Study: Irrigation and Scrubbing in Facial and Scalp Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019066', 'term': 'Facies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007507', 'term': 'Therapeutic Irrigation'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI left the institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-13', 'studyFirstSubmitDate': '2009-03-19', 'studyFirstSubmitQcDate': '2009-03-20', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Facial and Scalp Lacerations']}, 'referencesModule': {'references': [{'pmid': '10162000', 'type': 'BACKGROUND', 'citation': 'Stussman BJ. National Hospital Ambulatory Medical Care Survey: 1994 emergency department summary. Adv Data. 1996 May 17;(275):1-20. No abstract available.'}, {'pmid': '7741347', 'type': 'BACKGROUND', '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.'}, {'pmid': '16947027', 'type': 'BACKGROUND', '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.'}, {'pmid': '2393165', 'type': 'BACKGROUND', '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.'}, {'pmid': '15687474', 'type': 'BACKGROUND', 'citation': 'Sagerman PJ. Wounds. Pediatr Rev. 2005 Feb;26(2):43-9. doi: 10.1542/pir.26-2-43. No abstract available.'}, {'pmid': '5908175', 'type': 'BACKGROUND', 'citation': 'Krizek TJ, Davis JH. Endogenous wound infection. J Trauma. 1966 Mar;6(2):239-48. No abstract available.'}, {'pmid': '626301', 'type': 'BACKGROUND', '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.'}, {'pmid': '9516624', 'type': 'BACKGROUND', '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.'}, {'pmid': '12712026', 'type': 'BACKGROUND', '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.'}, {'pmid': '9437345', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. facial and scalp wounds acquired by blunt trauma,\n2. wounds incurring within a house or indoor gym,\n3. all ages, 1 month to 20 years of age.\n\nScalp 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.\n\nExclusion Criteria:\n\n1. Patients presenting with wounds that occur outdoors,\n2. Wounds greater than 12 hour old,\n3. Immunocompromised, malnourished or a diabetic,\n4. Intoxicated,\n5. Currently on antibiotics,\n6. Sickle cell anemia,\n7. Collagen vascular disease,\n8. Wounds requiring plastic surgery,\n9. Wounds from human or animal bites,\n10. Wounds not on the face or scalp,\n11. Patient's just discharged from the hospital within 72 hours,\n12. Wounds with foreign bodies or grossly contaminated,\n13. No suture nurses are present or available to suture."}, 'identificationModule': {'nctId': 'NCT00866892', 'briefTitle': 'Pediatric Pilot Study: Irrigation and Scrubbing in Facial and Scalp Wounds', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospitals and Clinics of Minnesota"}, 'officialTitle': 'A Pilot Study of Noncontaminated Facial and Scalp Wounds in the Pediatric Population: Getting Away Without Irrigation and Scrubbing', 'orgStudyIdInfo': {'id': '0808-081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'irrigation', 'interventionNames': ['Procedure: Irrigation']}, {'type': 'EXPERIMENTAL', 'label': 'no irrigation', 'interventionNames': ['Procedure: No irrigation']}], 'interventions': [{'name': 'Irrigation', 'type': 'PROCEDURE', 'description': 'irrigation', 'armGroupLabels': ['irrigation']}, {'name': 'No irrigation', 'type': 'PROCEDURE', 'description': 'no irrigation', 'armGroupLabels': ['no irrigation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Paul and Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minnesota"}], 'overallOfficials': [{'name': 'Jeffrey Louie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospitals and Clinics of Minnesota"}, {'name': 'Russell Grimsby, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospitals and Clinics of Minnesota"}, {'name': 'Michael Oakes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospitals and Clinics of Minnesota", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jeffrey Louie, MD', 'oldOrganization': "Children's Hospitals and Clinics of Minnesota"}}}}