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.: PACTR202212494403386 Date of Approval: 15/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of 5% Chlorhexidine versus 10%Povidone iodine in preventing pin sites infections in tibia external fixation- A randomized controlled trial.
Official scientific title Percutaneous pin site care in tibia external fixators: chlorhexidine or povidone iodine as dressing agent
Brief summary describing the background and objectives of the trial External has remained a versatile tool in the treatment of open tibia fractures, however one of it major drawbacks is the pin site infections which often contributes to the morbidity associated with this treatment method. Although there is no universally accepted dressing agent for the pin site, the appropriate choice of a particular agent contribute significantly to reduction in the rate of pin sites infection. While many research has shown superiority of antiseptic laden dressing over water or normal saline in preventing pin site infection, commonly used agents are povidone iodine, hydrogen peroxide and chlorhexidine. Recent studies lend credence to the effectiveness of Chlorhexidine compared to povidone iodine, however there is paucity of local studies comparing the effectiveness of these two solutions. This study evaluated the effectiveness of 5%Chlorhexidine compared to 10% povidone iodine in the preventing pin sites infection in tibia external fixation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2020
Actual trial start date 02/11/2020
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date 30/11/2022
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Chlorhexidine dressing agent 5% Chlorhexidine solution the dressing done as long till external fixator was removed Postoperatively, pin site dressing commenced on the fourth postoperative day. Antiseptic solution-impregnated sterile gauze placed around the external fixator pin site at the end of operation was removed and the pin site observed for bleeding, discharge, and infection indicators. Pin site dressing was done every 2 days until the patients were discharged. This was done by nurses on the ward who were trained in the chosen method of pin site dressing. After discharge from the hospital, the pin site dressings were done weekly till the pins were removed. 15
Control Group Povidone iodine dressing agent 10%Povidone iodine Dressing done till external fixator was removed Postoperatively, pin site dressing commenced on the fourth postoperative day. Antiseptic solution-impregnated sterile gauze placed around the external fixator pin site at the end of operation was removed and the pin site observed for bleeding, discharge, and infection indicators. Pin site dressing was done every 2 days until the patients were discharged. This was done by nurses on the ward who were trained in the chosen method of pin site dressing. After discharge from the hospital, the pin site dressings were done weekly till the pins were removed. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with open tibia fractures (Gustilo-Anderson II and IIIA) that meet the indication for placement of an external fixator. 2. Consenting patients who give both verbal and written informed consent for the study. 3. Absence of immunosuppressive co-morbidities such as diabetes mellitus or steroid therapy 1. Open fractures with an associated vascular deficit 2. Patients with significant peripheral vascular disease 3. Diabetic patients 4. Patients on corticosteroids Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 05/08/2020 Health Research Ethic Committee
Ethics Committee Address
Street address City Postal code Country
No 1 Adekunle Ajasin Street Owo 311111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of pin site infection in the control and experimental group 4th, twice weekly, weekly for first 6weeks
Secondary Outcome commonest organism from culture at the point when pin site infection is established
Secondary Outcome range of time of onset of infection as soon as pin site infection is estbaliched
Secondary Outcome grades of clinical infection at point when pin site infection is established
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre No Adekunle Ajasin Street Owo 311111 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Gbenga Jones No 1 Adekunle Ajasin Street Owo 311111 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Gbenga Jones No Adekunle Ajasin Owo 311111 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Anthony Olasinde No 1 Adekunle Ajasin Owo 311111 Nigeria
Dr Oluwatoyin Adetan no 1 Adekunle Ajasin Owo 311111 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gbenga Jones jonzylee@gmail.com +2348037858187 No 1 Adekunle Ajasin
City Postal code Country Position/Affiliation
Owo 311111 Nigeria Senior Registrar in Orthopaedic Surgery
Role Name Email Phone Street address
Public Enquiries Oluwatoyin Adetan detantoyin@gmail.com +2348033062594 No 1 Adekunle Ajasin
City Postal code Country Position/Affiliation
Owo 311111 Nigeria Chief Consultant Orthopaedic surgeon
Role Name Email Phone Street address
Scientific Enquiries Anthony Olasinde olasindetony@gmail.com +25675140847 Kampala International University western campus
City Postal code Country Position/Affiliation
Ishaka Bushenyi Uganda Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data may shared with interested researcher qualified researchers with academic interest in traumatology. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Statistical Analysis Plan,Study Protocol “Data requests can be submitted starting one year after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.” controlled
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