Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202005753191261 Date of Approval: 11/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Management of fingertip amputations
Official scientific title Fingertip amputation: A modified classification and a novel procedure for management
Brief summary describing the background and objectives of the trial Fingertip injuries and amputations are common and different protocols have been described for management; composite grafting, local flap coverage, healing of the wound with secondary intension and replantation of the fingertip. I will do trimming of both the amputated part and the fingertip then suturing the amputee in place with adequate coaptation. Postoperative cooling of the reattached part will be done for ten minutes every half an hour for five days. After that and during follow up visits, frequent debridement of a small piece of the reattached segment will be done in a proximal-to-distal manner without anesthesia (experimental group) for patients with severely crushed or lost amputated part, I will do a cross-finger flap (control group)
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2020
Actual trial start date 01/04/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
RP.20.01.55 IRB Faculty of medicine Mansoura university
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group fingertip reattachment single surgery reattachment of the amputated fingertip after wash and debridement continuous dressing and debridement till complete healing 20
Control Group cross finger flap coverage single surgery flap from the adjacent finger and skin grafting for the donor site 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients admitted with fingertip amputations Non-compliant patients Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/03/2020 IRB Faculty of medicine Mansoura university
Ethics Committee Address
Street address City Postal code Country
Algomhoria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome length of the finger 2 months
Secondary Outcome aesthetic appearance of the finger 2 months
Secondary Outcome 2-point discrimination 2 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
plastic surgery department Algomhoria street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Abdelshaheed Albostan street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Abdelshaheed Albostan street Mansoura 35516 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abdelshaheed becheerful@hotmail.com 00201002874175 Albostan street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of plastic surgery Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdelshaheed becheerful@hotmail.com 00201002874175 Albostan street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of plastic surgery Mansoura university
Role Name Email Phone Street address
Public Enquiries Mohamed Abdelshaheed becheerful@hotmail.com 00201002874175 Albostan street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of plastic surgery Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes demographic data of the participants, surgical approach and results Informed Consent Form,Statistical Analysis Plan 1 year data is available with the corresponding author upon request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information