This study is designed to compare effect of the two following methods on success rate of finger re-plantation: leech-therapy and wedge resection of finger nail. This work is a randomized clinical trial which will be done on 44 patients (22 patients by leech-therapy method and 22 patients by wedge resection of finger nail method). Inclusion criteria for the patients include requiring additional treatment for venous drainage during finger re-plantation and filling out the informed consent. Exclusion criteria include lack of filling out the informed consent, disagreement of the surgeon and surgeons' tendency to use leech-therapy and wedge resection of finger nail at the same time. Type of the treatment will be randomly selected based on a random number table. In leech-therapy method, leech is placed on the patient's finger with creating venous congestion (capillary refilling time of less than one sec). This process is repeated until the congestion is resolved and treatment intervals are adjusted according to the venous congestion. In another method, about one-third of the wedge nail is removed by a scalpel and is frequently stimulated by the gauze impregnated with heparin. Stimulation is repeated if venous congestion is induced. Completion criteria for the treatment are lack of venous congestion for 72 h without using any of the treatments or diagnosing necrotic finger by the surgeon. The surgeon will not be informed about the treatment process. Ultimately, success or failure of re-plantation is determined after observation and examination by the surgeon and the results of the two groups will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304288177N7
Registration date:2013-10-04, 1392/07/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-10-04, 1392/07/12
Registrant information
Name
Mohammad Javad Fatemi
Name of organization / entity
Burn Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 4275
Email address
mj-fatemi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of leech-therapy and wedge resection of finger nail on success rate of re-plantation in finger re-plantation patients
Public title
The effect of leech-therapy on finger re-plantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patients that require additional treatment for venous drainage during finger re-plantation.
2- Filling inform consent.
Exclusion criteria:
1- Lack of informed consent.
2- Disagreement of surgeon.
3- Surgeons tend to use leech therapy and wedge resection of finger nail same time.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central Department of Tehran University of Medical Sciences, Keshavarz Blvd, Tehran
City
Tehran
Postal code
1417653761
Approval date
2013-08-17, 1392/05/26
Ethics committee reference number
90-04-129-14929-91270
Health conditions studied
1
Description of health condition studied
Finger amputation
ICD-10 code
S68.1
ICD-10 code description
Traumatic amputation of other single finger (complete)(partial)
Primary outcomes
1
Description
Success of re-plantation surgery (survival and good venous drainage of replanted finger after two weeks)
Timepoint
Two weeks after surgery
Method of measurement
Observation, Examination
Secondary outcomes
empty
Intervention groups
1
Description
Using leech-therapy for controlling venous congestion after finger re-plantation surgery
Leech is placed on the patient's finger through creating venous congestion. Congestion will be relieved by blood suction of a leech. This process is repeated until congestion is resolved and treatment intervals are adjusted according to the venous congestion. Completion criteria of the treatment are lack of venous congestion for 72 h without using any of the treatments or diagnosing necrotic finger by the surgeon.
Category
Treatment - Other
2
Description
Wedge resection of finger nail for controlling venous congestion after finger re-plantation surgery
In this method, about one-third of the wedge nail is removed by a scalpel and is frequently stimulated by a gauze impregnated with heparin. Stimulation is repeated if venous congestion is induced. Completion criteria of the treatment are lack of venous congestion for 72 h without using any of the treatments or diagnosing necrotic finger by the surgeon.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatima Hospital
Full name of responsible person
Mohammad Javad Fatemi
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical
Full name of responsible person
Akbar Fotouhi
Street address
Central Department of Tehran University of Medical Sciences, Keshavarz Bvld, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran University of Medical
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hazrat Fatima Hospital
Full name of responsible person
Azam Skandari
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
Email
eskandary58@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hazrat Fatima Hospital
Full name of responsible person
Mohammad Javad Fatemi
Position
Associate Professor of Plastic and Reconstructive Surgery
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
Email
mj-fatemi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hazrat Fatima Hospital
Full name of responsible person
Azam Skandari
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)