- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01486719
Sensory Reconstruction of Finger Pulp Defect Using a Dorsal Digital Island Flap
December 5, 2011 updated by: The Second Hospital of Tangshan
Sensory reconstruction of the finger pulp is a challenging problem.
This article reports repair of the finger pulp defect using the dorsal digital island flap.
Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
From February 2008 to May 2009, the flap harvested from the dorsum of the middle phalanx of the same finger was used in 12 fingers in 12 patients.
The flaps ranged in size from 2.0 × 2.0 cm to 2.8 × 2.2 cm.
The mean pedicle length was 1.2 cm.
Neurorrhaphy between the dorsal branches of the PDN and PDN was performed in both sides in all cases.
Sensibility of the reconstructed finger pulp was evaluated by static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test.
The range of motion of the donor fingers was measured.
The data were compared to those of the opposite sides.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 60 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a finger pulp defect > 1.5 cm in length
- necessity to preserve finger length
- patients younger than 60 years .
Exclusion Criteria:
- injury to the dorsum of the middle phalanx of the reconstructed finger that precluded its use as donor site
- injury to the course of the vascular pedicle or opposite PDA
- defects < 1.5 cm in length.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
static 2-point discrimination test
Time Frame: Patients were followed for 16-23 months (mean, 19 months)
|
The patients were assessed at follow-up by an independent senior surgeon who did not attend the treatments.
Evaluation included active range of motion (ROM) of the DIP and proximal interphalangeal (PIP ) joints, and static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test of the reconstructed finger pulps.
These measurements were compared with those on the contralateral site.
According to the Michigan Hand Outcomes Questionnaire (MHQ), patients reported their satisfaction with the appearance of the injured hand.
The questions based on a 5-point response scale.
|
Patients were followed for 16-23 months (mean, 19 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Semmes-Weinstein monofilament test
Time Frame: Patients were followed for 16-23 months (mean, 19 months)
|
The patients were assessed at follow-up by an independent senior surgeon who did not attend the treatments.
Evaluation included active range of motion (ROM) of the DIP and proximal interphalangeal (PIP ) joints, and static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test of the reconstructed finger pulps.
These measurements were compared with those on the contralateral site.
|
Patients were followed for 16-23 months (mean, 19 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bene MD, Petrolati M, Raimondi P, Tremolada C, Muset A. Reverse dorsal digital island flap. Plast Reconstr Surg. 1994 Mar;93(3):552-7.
- Pelissier P, Casoli V, Bakhach J, Martin D, Baudet J. Reverse dorsal digital and metacarpal flaps: a review of 27 cases. Plast Reconstr Surg. 1999 Jan;103(1):159-65. doi: 10.1097/00006534-199901000-00025.
- Chen C, Tang P, Zhang X. Sensory reconstruction of a finger pulp defect using a dorsal homodigital island flap. Plast Reconstr Surg. 2012 Nov;130(5):1077-1086. doi: 10.1097/PRS.0b013e318267ef99.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (ACTUAL)
May 1, 2009
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
December 4, 2011
First Submitted That Met QC Criteria
December 5, 2011
First Posted (ESTIMATE)
December 6, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 6, 2011
Last Update Submitted That Met QC Criteria
December 5, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHEN-19750306
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma
-
Humacyte, Inc.Active, not recruitingTrauma | Trauma Injury | Trauma, Multiple | Trauma BluntUkraine
-
Wonju Severance Christian HospitalNational Research Foundation of KoreaRecruitingTrauma Injury | Trauma, MultipleKorea, Republic of
-
University Hospital, AngersRecruiting
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedTrauma Injury | Trauma, MultipleTurkey
-
Rabin Medical CenterIsraeli Ministry of SecurityUnknown
-
Oslo University HospitalUniversity of Oslo; Sunnaas Rehabilitation Hospital; South-Eastern Norway Regional...RecruitingTrauma Injury | Trauma, Multiple | PolytraumaNorway
-
Chang, Steve S., M.D.Santa Barbara Cottage Hospital; Accumetrics, Inc.CompletedHead Injury Trauma BluntUnited States
-
Assistance Publique - Hôpitaux de ParisFrancophone Pediatric Resuscitation and Emergency Group (GFRUP)Completed
-
Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedTrauma, Multiple | Trauma Severity Indices | Injuries, Multiple | Norway/Epidemiology | Trauma Centers/Statistics & Numerical Data
-
University Hospital, ToulouseNot yet recruiting
Clinical Trials on Sensate Dorsal Digital Island Flap
-
The Second Hospital of TangshanChinese PLA General HospitalCompletedSensory Reconstruction of the Volar Aspect of the Finger | The Heterodigital Neurocutaneous Island FlapChina
-
The Second Hospital of TangshanCompletedSensory Restoration | Soft Tissue ReconstructionChina
-
The Second Hospital of TangshanChinese PLA General HospitalCompletedSoft Tissue Defect | Sensory Reconstruction of Digits | Multiple Digital DefectsChina
-
The Second Hospital of TangshanChinese PLA General HospitalCompletedNerve Injury | Digital Pulp Defect
-
The Second Hospital of TangshanChinese PLA General HospitalCompletedSoft Tissue Defect of Digit
-
The Second Hospital of TangshanChinese PLA General Hospital; The Second Hospital of QinhuangdaoCompleted
-
dr. Muhammad Abdelhafez Mahmoud, MDCompleted
-
dr. Muhammad Abdelhafez Mahmoud, MDCompletedChordee | Hypospadias, Penoscrotal
-
The Second Hospital of TangshanChinese PLA General HospitalCompletedSoft Tissue Injuries | Finger InjuriesChina