Upper Extremity DefectsNCT04007497
Reconstruction of Hand and Upper Extremities Defects by Thin Random Pedicle Abdominal Flaps, Still a Valid Option in Developing Countries: A Cross Sectional Study
An observational study of Upper Extremity Defects, run by University of Jordan at 1 site in Jordan.
Trial summary
Traumatic defects of the soft tissues of the hand and upper extremities are common and may be challenging to the reconstructive surgeon. Several reconstructive procedures have been described to manage these defects, including local, regional, distant, and free flaps. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Upper Extremity Defects
- How many people
- 34 participants
- Where
- 1 siteJordan
- Study dates
- 25 Jul 2017to 23 Mar 2019
- 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 2 years and older
- All sexes
- Child, Adult, Older adult
Study population: patients with different traumatic defects in the hand and upper extremities who underwent reconstruction by random pedicle abdominal flaps.
Who may be able to join
- different traumatic defects in the hand and upper extremities who underwent reconstruction by random pedicle abdominal flaps
Who cannot join
- Patients with incomplete data about the patient and the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Traumatic defects of the soft tissues of the hand and upper extremities are common and may be challenging to the reconstructive surgeon. Several reconstructive procedures have been described to manage these defects, including local, regional, distant, and free flaps. The aim of this study is to report the techniques, outcomes, and complications of pedicle abdominal flaps in reconstructing hand and upper extremity defects. We included patients with different traumatic defects in the hand and upper extremities who underwent reconstruction by random pedicle abdominal flaps between 2002 and 2017. Data was collected and analyzed, variables studied included; patient age and sex, etiology and size of the defect, complications, outcomes, and the need for further revision procedures. Potential factors affecting flap survival were examined using appropriate statistical analysis.
Read the detailed description
Traumatic soft tissue defects of the hand and upper extremity are common and may be challenging to the reconstructive surgeon, especially when they are severe and associated with exposed vital structures such as tendons, nerves, bones, and joints. Although these defects are rarely lethal; they are invariably resource demanding, and a source of significant long-term disability. Several reconstructive procedures have been described to cover hand and upper extremities soft tissue defects, including local, regional, distant, and free flaps. Traditionally, pedicle abdominal flaps, whether axial or randomly based, have been considered the standard for successful upper limb reconstruction.
With the introduction of microsurgery in the seventies of the last century, microsurgical free tissue transfers have become the gold standard for upper extremities functional reconstruction. Free flaps and other microsurgical techniques have been used to achieve early, functional, custom-tailored reconstructive solutions for upper limbs injuries. However, despite the superiority of free flaps, this option may not be always accessible especially in developing countries, owing to the high cost and technical demands. Moreover, they may be contraindicated in certain circumstances. In these situations, pedicle abdominal flaps may once again come into the light as an alternative option for safe and effective upper extremities reconstruction.
At Jordan University Hospital, with limited microsurgical facilities, the investigators have been using random pedicle abdominal flaps in patients with different traumatic hand and upper extremities defects. The aim of this retrospective study is to report the investigator's experience in using this technique, in regards to the indications, complications, outcomes, and evaluating factors affecting flap survival rate.
- Conditions
- Upper Extremity Defects
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstruction of hand and upper extremities defects by thin random pedicle abdominal flaps
The investigators will examine success rate of randome abdominal flap in managing upper extremity's defects
Measured: 2002 and 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start25 Jul 2017
- Primary completion15 Oct 2018
- Study completion23 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity DefectsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saif Aldeen AlRyalat, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007497
- Sponsor's protocol ID
- UJordan plastic
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Hand and Upper Extremities Defects by Thin Random Pedicle Abdominal Flaps, Still a Valid Option in Developing Countries: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04007497
- Acronym / sponsor ID
- UJordan plastic
- Conditions
- Upper Extremity Defects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 23 Mar 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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.
Traumatic defects of the soft tissues of the hand and upper extremities are common and may be challenging to the reconstructive surgeon. Several reconstructive procedures have been described to manage these defects, including local, regional, distant, and free flaps. The aim of this study is to report the techniques, outcomes, and complications of pedicle abdominal flaps in reconstructing hand and upper extremity defects. We included patients with different traumatic defects in the hand and upper extremities who underwent reconstruction by random pedicle abdominal flaps between 2002 and 2017. Data was collected and analyzed, variables studied included; patient age and sex, etiology and size of the defect, complications, outcomes, and the need for further revision procedures. Potential factors affecting flap survival were examined using appropriate statistical analysis.
Detailed description
Traumatic soft tissue defects of the hand and upper extremity are common and may be challenging to the reconstructive surgeon, especially when they are severe and associated with exposed vital structures such as tendons, nerves, bones, and joints. Although these defects are rarely lethal; they are invariably resource demanding, and a source of significant long-term disability. Several reconstructive procedures have been described to cover hand and upper extremities soft tissue defects, including local, regional, distant, and free flaps. Traditionally, pedicle abdominal flaps, whether axial or randomly based, have been considered the standard for successful upper limb reconstruction.
With the introduction of microsurgery in the seventies of the last century, microsurgical free tissue transfers have become the gold standard for upper extremities functional reconstruction. Free flaps and other microsurgical techniques have been used to achieve early, functional, custom-tailored reconstructive solutions for upper limbs injuries. However, despite the superiority of free flaps, this option may not be always accessible especially in developing countries, owing to the high cost and technical demands. Moreover, they may be contraindicated in certain circumstances. In these situations, pedicle abdominal flaps may once again come into the light as an alternative option for safe and effective upper extremities reconstruction.
At Jordan University Hospital, with limited microsurgical facilities, the investigators have been using random pedicle abdominal flaps in patients with different traumatic hand and upper extremities defects. The aim of this retrospective study is to report the investigator's experience in using this technique, in regards to the indications, complications, outcomes, and evaluating factors affecting flap survival rate.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with different traumatic defects in the hand and upper extremities who underwent reconstruction by random pedicle abdominal flaps.
Key inclusion criteria (1 listed)
- different traumatic defects in the hand and upper extremities who underwent reconstruction by random pedicle abdominal flaps
Key exclusion criteria (1 listed)
- Patients with incomplete data about the patient and the surgery
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
Reconstruction of hand and upper extremities defects by thin random pedicle abdominal flaps
Time frame: 2002 and 2017
The investigators will examine success rate of randome abdominal flap in managing upper extremity's defects
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 9 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Upper Extremity Defects, run by University of Jordan at 1 site in Jordan.
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: finished, as of the sponsor's last update on 9 Jul 2019. 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 Jordan. 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 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?
Reconstruction of hand and upper extremities defects by thin random pedicle abdominal flaps (time frame: 2002 and 2017). 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 9 Jul 2019.