Scalp LacerationPhase 3NCT00353769
Comparison Study on Hair Apposition Technique Performed Between Nurses and Doctors in Emergency Department.
A Phase 3 study testing Hair Apposition Technique in people with Scalp Laceration, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The purpose of this study is to compare the effectiveness, complications and benefits of Hair Apposition Technique(HAT)performed by nurses or doctors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Scalp Laceration
- What is being tested?
- Hair Apposition Technique
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2002to Feb 2005
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All age group
- Linear lacerations of scalp
- Lacerations less than 10cm in length
- Hair at least 3cm in length
Who cannot join
- Severely contaminated wounds
- Actively bleeding wounds
- Patients with unstable vital signs or altered mental state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blinded Comparative Study on Hair Apposition Technique Performed Between Nurses and Doctors in Emergency Department.(HAT2 Study)
The purpose of this study is to compare the effectiveness, complications and benefits of Hair Apposition Technique(HAT)performed by nurses or doctors.
Read the detailed description
Hair Apposition Technique (HAT) is a relatively new technique for treating certain scalp lacerations. It has been shown to be equally acceptable as compared to the standard toilet and suture. This procedure has been the technique of choice for suitable scalp lacerations in Department of Emergency Medicine, Singapore General Hospital (DEM, SGH) and Emergency Medicine Department, National University Hospital (EMD, NUH).
Currently HAT is being performed by doctors in the respective hospitals. Nurses, on the other hand, are routinely using tissue adhesives for minor wound closure. However, nurses in Kandang Kerbau Women and Children Hospital (KKWCH) have been routinely using HAT for 1 year now. Studies had been also been done by nurses in treating of minor wounds using various tissue adhesives as well as hair knotting technique.The trend of nurses handling minor wounds with tissue adhesives, hair knotting technique as well as HAT suggested the possibility of nurses performing HAT to a degree as competent as a doctor.
This study aims to compare the effectiveness, complications and benefits HAT performed between nurses and doctors in the Emergency Department.
- Conditions
- Scalp Laceration
- Being tested
- Hair Apposition Technique
- Keywords
- scalp laceration, tissue adhesive, wound care, cost effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair Apposition TechniqueProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of any complications, namely infection, scarring, bleeding, wound breakdown and allergy
Satisfactory wound healing
Secondary outcomes (2)
Duration of procedure
Pain perception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startNov 2002
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp LacerationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ong EH Marcus, M.D, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353769
- Sponsor's protocol ID
- DCR/P15/2003
- Status last verified
- Feb 2017
- First submitted
- 17 Jul 2006
- Last updated
- 10 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded Comparative Study on Hair Apposition Technique Performed Between Nurses and Doctors in Emergency Department.(HAT2 Study)
- ClinicalTrials.gov ID
- NCT00353769
- Acronym / sponsor ID
- DCR/P15/2003
- Conditions
- Scalp Laceration
- Keywords
- scalp laceration, tissue adhesive, wound care, cost effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Feb 2005
- First posted
- 19 Jul 2006 (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.
The purpose of this study is to compare the effectiveness, complications and benefits of Hair Apposition Technique(HAT)performed by nurses or doctors.
Detailed description
Hair Apposition Technique (HAT) is a relatively new technique for treating certain scalp lacerations. It has been shown to be equally acceptable as compared to the standard toilet and suture. This procedure has been the technique of choice for suitable scalp lacerations in Department of Emergency Medicine, Singapore General Hospital (DEM, SGH) and Emergency Medicine Department, National University Hospital (EMD, NUH).
Currently HAT is being performed by doctors in the respective hospitals. Nurses, on the other hand, are routinely using tissue adhesives for minor wound closure. However, nurses in Kandang Kerbau Women and Children Hospital (KKWCH) have been routinely using HAT for 1 year now. Studies had been also been done by nurses in treating of minor wounds using various tissue adhesives as well as hair knotting technique.The trend of nurses handling minor wounds with tissue adhesives, hair knotting technique as well as HAT suggested the possibility of nurses performing HAT to a degree as competent as a doctor.
This study aims to compare the effectiveness, complications and benefits HAT performed between nurses and doctors in the Emergency Department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All age group
- Linear lacerations of scalp
- Lacerations less than 10cm in length
- Hair at least 3cm in length
Key exclusion criteria (3 listed)
- Severely contaminated wounds
- Actively bleeding wounds
- Patients with unstable vital signs or altered mental state
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 |
|---|---|---|
| Hair Apposition Technique | Procedure or surgery | – |
Primary outcome
Presence of any complications, namely infection, scarring, bleeding, wound breakdown and allergy
Satisfactory wound healing
2 secondary outcomes
Duration of procedure
Pain perception
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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.
Ong EH Marcus, M.D principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hair Apposition Technique in people with Scalp Laceration, run by Singapore General Hospital at 1 site in Singapore.
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 3 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: finished, as of the sponsor's last update on 10 Feb 2017. 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 Singapore. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of any complications, namely infection, scarring, bleeding, wound breakdown and allergy. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.