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.: PACTR201511001343882 Date of Approval: 06/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Leg and foot complex wound reconstruction
Official scientific title Free Gracilis muscle flap or local fasciocutaneous perforator flaps for reconstruction of leg and foot?
Brief summary describing the background and objectives of the trial Distal half leg complex wounds are usually a formidable problem that necessitate either local or free flap coverage. The aim of this study is to compare free Gracilis flap (fGF) to local fasciocutaneous perforator flap (lFPF) in reconstructing complex soft tissue leg and foot defects. Patients and Methods: Patients with soft tissue defects in the leg and/or foot requiring tissue coverage with a flap in the period between 2011 and 2014 are assigned (block randomization) to either a fGF or lFPF procedure. The outcome measures to be addressed are partial or complete flap loss, complications, operating time, number of operative scrubbed staff, costs, length of hospital stay, as well as donor and recipient site morbidity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied complex lower limb wounds
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2011
Actual trial start date 01/12/2012
Anticipated date of last follow up 29/05/2015
Actual Last follow-up date 29/05/2015
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
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 Randomised Block Randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Free Gracilis group one time procedure operation takes 4 -6 hours 15
Experimental Group Local Fasciocutaneous Perforator group one time procedure operation takes 2 -3 hours 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients > 15 year old presenting with soft tissue defects of the leg and/or foot that needed coverage with a flap. Patients presenting with a soft tissue defect larger than 50 cm2 are excluded from the study. Patients with systemic vascular diseases like atherosclerosis or vasculitis as well as patients with peripheral ischemia (Ankle Brachial Index less than 0.7)8 are excluded from the study. 15 Year(s) 70 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 06/11/2010 Suez Canal University faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Ring road, 5 Ismailia 41111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome partial or complete flap loss immediate 3 days 1 week 1 month
Secondary Outcome complications, operating time, number of operative scrubbed staff, costs, length of hospital stay, as well as donor and recipient site morbidity immediate 3 days 1 week 1 month each month 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospital Ring road, 5 Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Suez Canal University Ring road, 5 Ismailia 41111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Hospital Ring road, 5 Ismailia 41111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Linkoping University Linkoping University Linkoping 58185 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Folke Sjoberg Folke.sjoberg@liu.se 0046705571820 10 Garnisonsgaten
City Postal code Country Position/Affiliation
Linkoping 58185 Sweden Bun Centr Dept Hand, Plastic Surg; Dept Clin Exper Medicine, Linkoping Univ Sweden
Role Name Email Phone Street address
Public Enquiries Islam Abdelrahman islam.abdelrahman@liu.se 0046762900430 Vapnaregatan 34
City Postal code Country Position/Affiliation
Linkoping 58649 Sweden Platic Surg unit, Suez Canal Univ;Burn Centre, Dep Hand Plstic surg Linkoping Univ Sweden
Role Name Email Phone Street address
Scientific Enquiries Islam Abdelrahman islam.abdelrahman@liu.se 0046762900430 Vapnaregatan34
City Postal code Country Position/Affiliation
Linkoping 58649 Sweden Plastic surgery unit, Surgery Dept. Univ Suez Canal, 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
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