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.: PACTR201709002524992 Date of Approval: 17/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Use of perforator flaps for leg and foot reconstruction
Official scientific title Use of perforator flaps for leg and foot reconstruction
Brief summary describing the background and objectives of the trial Perforator vessels are those where the source artery is deep and the branch that carries blood to the fasciocutaneous tissues passes through the overlying deep fascia. Soft tissue defects in the lower extremity, especially distal third of leg, present a challenge to reconstructive surgeons due to lack of reliable local flaps. The reappraisal of the works of Manchot and Salmon, by Taylor and Palmer, which defined the static vascular territories of source arteries as angiosomes, opened new era in flap design. As a result of this evolution, and following the works pubelished by Koshima and Soeda in 1989 separetly, began the era of perforator flaps.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases,traumatic soft tissue loss in leg and foot
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/10/2017
Actual trial start date 01/10/2017
Anticipated date of last follow up 01/01/2020
Actual Last follow-up date 01/01/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group surgical intervention (pedicled perforator flap) The operations will be performed using magnification loupes (3.5¿4.0x) and microsurgical instruments. Once the perforator is identified, the flap will be designed around the perforator or perforators according to the location and size of the defect. The dimensions of the flap are based upon the size of defect and the movement of the flap, taking into account the need to avoid excessive tension 20
Experimental Group surgical intervention (free perforator flap) Two teams, the first team starts exploring the limb for the recipient vessel, this is done under loupe magnification at a location marked by pre-operative hand held Doppler and the knowledge of regional anatomy. The second team simultaneously begins elevating the perforator flap and its pedicle. Microvascular anastomosis will done under operating microscope for one artery and one or two veins 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Traumatic soft tissue defects on foot and leg. 2. Simple defects i.e., soft tissue loss, with or without, tendon injury. 3. Patients from 6 years to 60 years old 1. Other causes of soft tissue defects e.g. (Diabetic, Vascular, post malignant resection). 2. Complex defects (soft tissue with bone injury). 3. Patients below 6 years or above 60 years old. 4. Patients with debilitating diseases e.g chronic renal failure, diabetes mellitus¿.etc. 6 Year(s) 60 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 27/08/2017 Ethical committee, faculty of medicine, assiut university
Ethics Committee Address
Street address City Postal code Country
assiut university assiut city 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome survival of the flap first day postoperative second day post operative third day postoperative first week postoperative
Secondary Outcome Quality of coverage (function of the affected limb). one month postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut university hospital Assiut university Assiut city 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
assiut university hospital Assiut university Assiut city 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Assiut university hospital Assiut university Assiut city 71515 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Assiut university hospital Assiut university Assiut city 71515 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek El gammal tarek.elgammal@aun.edu.eg 002088043060 Assiut university
City Postal code Country Position/Affiliation
Assiut city 71515 Egypt
Role Name Email Phone Street address
Public Enquiries youssef hassan plasticclinic66@gmail.com 00201001166118 Assiut university
City Postal code Country Position/Affiliation
Assiut city 71515 Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Osman ahmedkamal@aun.edu.eg 00201060118001 Assiut university
City Postal code Country Position/Affiliation
Assiut city 71515 Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks
Changes to trial information