Facial and Scalp LacerationsNCT00866892
Pediatric Pilot Study: Irrigation and Scrubbing in Facial and Scalp Wounds
A study testing Irrigation and No irrigation in people with Facial and Scalp Lacerations, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 20 years
- Conditions the study is for
- Facial and Scalp Lacerations
- What is being tested?
- Irrigation and No irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Saint Paul and Minneapolis, Minnesota
About this study
Official title: A Pilot Study of Noncontaminated Facial and Scalp Wounds in the Pediatric Population: Getting Away Without Irrigation and Scrubbing
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
- Being tested
- Irrigation, No irrigation
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrrigationProcedure or surgery
irrigation
No irrigationProcedure or surgery
no irrigation
| Study group | Role | What they receive |
|---|---|---|
| irrigation | Active comparator | Not described Receives: Procedure: Irrigation |
| no irrigation | Experimental | Not described Receives: Procedure: No irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Facial and Scalp LacerationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey Louie, MD, Principal investigator, Children's Hospitals and Clinics of MinnesotaRussell Grimsby, RN, Principal investigator, Children's Hospitals and Clinics of MinnesotaMichael Oakes, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866892
- Sponsor's protocol ID
- 0808-081
- Status last verified
- Jul 2015
- First submitted
- 19 Mar 2009
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stussman BJ. National Hospital Ambulatory Medical Care Survey: 1994 emergency department summary. Adv Data. 1996 May 17;(275):1-20. No abstract available.
PubMed 10162000Hollander 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.
PubMed 7741347Islam 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.
PubMed 16947027Baker 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.
PubMed 2393165Sagerman PJ. Wounds. Pediatr Rev. 2005 Feb;26(2):43-9. doi: 10.1542/pir.26-2-43. No abstract available.
PubMed 15687474Krizek TJ, Davis JH. Endogenous wound infection. J Trauma. 1966 Mar;6(2):239-48. No abstract available.
PubMed 5908175Haury 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.
PubMed 626301Hollander 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.
PubMed 9516624Valente 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.
PubMed 12712026Hollander 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.
PubMed 9437345
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Noncontaminated Facial and Scalp Wounds in the Pediatric Population: Getting Away Without Irrigation and Scrubbing
- ClinicalTrials.gov ID
- NCT00866892
- Acronym / sponsor ID
- 0808-081
- Conditions
- Facial and Scalp Lacerations
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| irrigation | Active comparator | Procedure: Irrigation |
| no irrigation | Experimental | Procedure: No irrigation |
Who may qualify
- Ages
- 1 month to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Patients presenting with wounds that occur outdoors,
- Wounds greater than 12 hour old,
- Immunocompromised, malnourished or a diabetic,
- Intoxicated,
- Currently on antibiotics,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigationirrigation | Procedure or surgery | irrigation |
| No irrigationno irrigation | Procedure or surgery | no irrigation |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Background: PubMed 10162000Stussman BJ. National Hospital Ambulatory Medical Care Survey: 1994 emergency department summary. Adv Data. 1996 May 17;(275):1-20. No abstract available.
- Background: PubMed 7741347Hollander 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.
- Background: PubMed 16947027Islam 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.
- Background: PubMed 2393165Baker 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.
- Background: PubMed 15687474Sagerman PJ. Wounds. Pediatr Rev. 2005 Feb;26(2):43-9. doi: 10.1542/pir.26-2-43. No abstract available.
- Background: PubMed 5908175Krizek TJ, Davis JH. Endogenous wound infection. J Trauma. 1966 Mar;6(2):239-48. No abstract available.
- Background: PubMed 626301Haury 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.
- Background: PubMed 9516624Hollander 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.
- Background: PubMed 12712026Valente 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.
- Background: PubMed 9437345Hollander 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Louie, MD principal investigator
Children's Hospitals and Clinics of Minnesota
Russell Grimsby, RN principal investigator
Children's Hospitals and Clinics of Minnesota
Michael Oakes, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation and No irrigation in people with Facial and Scalp Lacerations, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00866892, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.