Pinprick Sensation DiminishedNCT02419885
Evaluation of Result and Influence Factors on Composite Graft in Fingertip Amputation
An observational study of Pinprick Sensation Diminished and Amputation, Traumatic, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Fingertips facilitate smooth motor activity, precise sensation, and the delicate movement of the hands and have an aesthetic function. Fingertip injuries are defined as injuries occurring distal to the insertion of the flexor and extensor tendons. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pinprick Sensation Diminished, Amputation, Traumatic, Pain
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Jun 2017
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective chart review study. Patients were collected since 1990,
Who may be able to join
- February 1990 and June 2015, patients received composite graft in fingertip amputation
Who cannot join
- patients refused to participate the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 80708
huang shu-hung, MD, 886-7-3121101 ext. 7676, huangsh63@gmail.com
About this study
Fingertips facilitate smooth motor activity, precise sensation, and the delicate movement of the hands and have an aesthetic function. Fingertip injuries are defined as injuries occurring distal to the insertion of the flexor and extensor tendons. These injuries are one of the most common trauma injuries presented in acute care settings, accounting for approximately 4.8 million emergency department visits per year in the United States.(1) Fingertip amputations may not constitute the majority among these fingertip injuries but can have a complex spectrum of injury. In these cases, the reconstruction methodologies focus on preserving the digital length, ensuring adequate soft tissue coverage, preserving the nail structure, achieving a well-contoured and painless fingertip, and restoring durable and sensate skin.
There are so many factor that influence the result of composite graft in distal finger tip amputation. Investigators will collected the data including the size of amputee , shape, level of amputation, mechanism of amputation, if hyperbaric oxygen therapy, operation procedures.
Read the detailed description
Fingertip amputations underwent
- modified composite grafting with pulp Adipo-fascia advance flap
- composite graft
- revision amputation was collected in this study
Follow-up was arranged in out-patient department, including:
type of amputation ( Hirase classification, ) 2-point discrimination test, DASH(Disabilities of the Arm, Shoulder, and Hand) outcome measure, graft survival, pain evaluation with visual Analog scale other associated treatment such as hyperbaric oxygen therapy length of finger shortening at 6 month after operation
- Conditions
- Pinprick Sensation Diminished, Amputation, Traumatic, Pain
- Keywords
- finger amputation, composite graft, adipo-fascia flap
- Medical subject headings
- Somatosensory Disorders, Amputation, Traumatic, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
graft survival
composite graft survival rate
Measured: postoperatively after 6 weeks
Secondary outcomes (3)
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
hand function evaluation
Measured: postoperatively 24 weeks
subjective self-evaluation questionnaire
subjective self-evaluation of finger looking
Measured: postoperatively 24 weeks
length of finger shortening
finger length
Measured: postoperatively 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJan 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pinprick Sensation DiminishedStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huang shu-hung, MD, Study chair, Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419885
- Sponsor's protocol ID
- KMUH-IRB
- Status last verified
- Dec 1990
- First submitted
- 6 Apr 2015
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Result and Influence Factors on Composite Graft in Fingertip Amputation
- ClinicalTrials.gov ID
- NCT02419885
- Acronym / sponsor ID
- KMUH-IRB
- Conditions
- Pinprick Sensation Diminished, Amputation, Traumatic, Pain
- Keywords
- finger amputation, composite graft, adipo-fascia flap
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 17 Apr 2015 (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.
Fingertips facilitate smooth motor activity, precise sensation, and the delicate movement of the hands and have an aesthetic function. Fingertip injuries are defined as injuries occurring distal to the insertion of the flexor and extensor tendons. These injuries are one of the most common trauma injuries presented in acute care settings, accounting for approximately 4.8 million emergency department visits per year in the United States.(1) Fingertip amputations may not constitute the majority among these fingertip injuries but can have a complex spectrum of injury. In these cases, the reconstruction methodologies focus on preserving the digital length, ensuring adequate soft tissue coverage, preserving the nail structure, achieving a well-contoured and painless fingertip, and restoring durable and sensate skin.
There are so many factor that influence the result of composite graft in distal finger tip amputation. Investigators will collected the data including the size of amputee , shape, level of amputation, mechanism of amputation, if hyperbaric oxygen therapy, operation procedures.
Detailed description
Fingertip amputations underwent
- modified composite grafting with pulp Adipo-fascia advance flap
- composite graft
- revision amputation was collected in this study
Follow-up was arranged in out-patient department, including:
type of amputation ( Hirase classification, ) 2-point discrimination test, DASH(Disabilities of the Arm, Shoulder, and Hand) outcome measure, graft survival, pain evaluation with visual Analog scale other associated treatment such as hyperbaric oxygen therapy length of finger shortening at 6 month after operation
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective chart review study. Patients were collected since 1990,
Key inclusion criteria (1 listed)
- February 1990 and June 2015, patients received composite graft in fingertip amputation
Key exclusion criteria (1 listed)
- patients refused to participate the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
graft survival
Time frame: postoperatively after 6 weeks
composite graft survival rate
3 secondary outcomes
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time frame: postoperatively 24 weeks
subjective self-evaluation questionnaire
Time frame: postoperatively 24 weeks
length of finger shortening
Time frame: postoperatively 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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.
huang shu-hung, MD study chair
Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pinprick Sensation Diminished and Amputation, Traumatic, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Apr 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huang shu-hung, MD (886-7-3121101 ext. 7676, huangsh63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft survival (time frame: postoperatively after 6 weeks). 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 17 Apr 2015.