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.: PACTR201907727663059 Date of Approval: 29/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Povidone Iodine for the treatment of prolonged air leaks after lung surgery?
Official scientific title Effectiveness of Povidone Iodine for the treatment of prolonged air leaks after lung surgery?
Brief summary describing the background and objectives of the trial The duration of drainage of patients who have had pulmonary surgery is sometimes prolonged (beyond 5 days) because of aerial parenchymal leakage, because of a high morbidity (pulmonary infections and atelectases) as well as an increase in duration and cost of hospitalization. Several solutions have been made to remedy these air leaks, and accelerate pulmonary scarring and pleurodesis, among which, Betadine. But, there are no randomized, prospective studies that prove the effectiveness of Betadine in prolonged parenchymal leakage. No randomized prospective study has demonstrated the efficacy of Betadine in shortening the duration of thoracic drainage during postoperative parenchymal leakage. Objective: Does Betadine administered through drains for patients with prolonged air leaks have an effect on shortening the duration of thoracic drainage?
Type of trial CCT
Acronym (If the trial has an acronym then please provide) No
Disease(s) or condition(s) being studied Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL https://pactr.samrc.ac.za/Researcher/TrialRegister.aspx?TrialID=8152
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 a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intra pleural Povidone Iodine 40ml of Povidone Iodine administrated every 10seconds (5 ml each time) 1 injection a day with a total period of Three successive days If air leak stops, the povidone Iodine injection is stopped. Betadine injection is made through the chest tube (s). A pleural anesthesia prior to the injection of Betadine was made by injection through the drains of a total volume of 20ml Xylocaine 2% (either through a drain or divided into two portions of 10ml each in each drain). Then, to ensure better analgesia, the patient was asked to mobilize every 2min to ensure a good diffusion of Xylocaine injected throughout the pleural cavity to avoid vagal discomfort secondary to pain caused by irritation of the skin. pleura by the Betadine. After 15 min of the injection of xylocaine, 40 ml of pure betadine was injected by a Guillon syringe through the drain (s). The injection rate was 5ml every 10sec. After injection of the full amount of Betadine, the drains were siphoned (without aspiration by the Jeannerey column) for 30min with normal breathing in the semi-sitting position of the patient, before putting the jar back in. aspiration. Betadine injection was repeated for 3 days following the same technique in case of persistent bubbling (whether spontaneous or caused by coughing). In cases where bubbling stops after 1 or 2 days, Betadine injection was not made for the total duration of 3 days. After administration of Betadine, the assessment of bubbling was made 3 times daily and at each morning visit. 20
Control Group No Povidone 0 ml 3 days No injection of Intra pleural Povidone iodine 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who underwent lung surgery and who had prolonged air leak in drainage (more than 5 days of air leak) after surgery; Malignant pleural effusion 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 90 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 25/05/2019 persons protection committee
Ethics Committee Address
Street address City Postal code Country
Majida Boulila Sfax 3003 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Air leak stop after the administration of Povidone iodine One day, two days, and three days after the administration of Povidone Iodine
Secondary Outcome The evolution after the administration of Povidone iodine and the days of total drainage the number of days needed to remove chest tubes after the last administration of Povidone Iodine
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Habib Bourguiba University Hospital Majida Boulila Sfax 3003 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Zied Chaari Habib Bourguiba University Hospital Sfax 3003 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Habib Bourguiba Hospital Majida Boulila Sfax 3003 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Abdessalem Hentati Habib Bourguiba University Hospital Sfax 3003 Tunisia
Imed Frikha Habib Bourguiba University Hospital Sfax 3003 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zied Chaari chaari.zied1@gmail.com 0021622789861 Majida Boulila
City Postal code Country Position/Affiliation
Sfax 3003 Tunisia Thoracic Surgeon Depatement of thoracic and cardiovascular surgery
Role Name Email Phone Street address
Public Enquiries Zied Chaari chaari.zied1@gmail.com 0021622789861 Majida Boulila
City Postal code Country Position/Affiliation
Sfax 3003 Tunisia Habib Bourguiba Hospital
Role Name Email Phone Street address
Scientific Enquiries Zied Chaari chaari.zied1@gmail.com 0021622789861 Majida Boulila
City Postal code Country Position/Affiliation
Sfax 3003 Tunisia Habib Bourguiba University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Personnal Excel Tab Uploaded Statistical Analysis Plan,Study Protocol 1 year Open / first part / access for all scientists and doctors
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Personnal Excel Tab Uploaded Yes Personnal Excel Tab Uploaded 26/07/2019 31/10/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Personnal Excel Tab Uploaded
Changes to trial information