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.: PACTR202508912216526 Date of Registration: 14/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of iodophor-impregnated incise drape on skin bacterial recolonization and surgical site infections following open brain and spine surgeries
Official scientific title Effect of iodophor-impregnated incise drape on skin bacterial recolonization and surgical site infections following open brain and spine surgeries
Brief summary describing the background and objectives of the trial Background: Surgical site infection (SSI) causes significant management challenges in surgical practice. In Neurosurgery, the consequences can be devastating. It may result in prolonged antibiotic therapy, revision surgeries, increased length of hospital stay, increased treatment costs, reduced quality of life, and mortality. SSI results from microbial contamination of surgical wounds commonly by bacteria translocation from adjacent skin. Iodophor-impregnated incise drapes (IIID) were developed with the aim of preventing intraoperative skin bacteria re-colonization and contamination of surgical wounds. However, its actual effectiveness in achieving this has been a subject of debate with no consensus among the studies and guidelines available. Objectives: This study aims to evaluate the effect of iodophor-impregnated incise drape on skin bacterial re-colonization and surgical site infection in patients undergoing cranial and spine surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied Skin bacterial recolonization and surgical site infection following spine surgery
Purpose of the trial Prevention
Anticipated trial start date 08/11/2023
Actual trial start date 08/01/2024
Anticipated date of last follow up 31/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 3M Iodophor impregnated incised drape Single Before incision till the end of surgery For the subjects randomised to the treatment sub-group A, a size 60cm X 35cm IIID (Ioban 2, 3M® Science, Minneapolis, USA) with an incised area of 35cm X 35cm will be tightly placed to adhere to the isolated area of skin and an area of the surrounding sterile drape. This will be achieved by a two-person application technique according to the 3M Ioban application guideline. With the surgeon and the assistant (or 2 assistants) standing on the opposite side of the skin area to be applied, the hands are positioned on the outer edges of the Ioban with the print side facing up. This will keep a slight tension on the drape while removing the liner and keep it as wrinkle-free as possible. The liner side (white edge) as shown is separated from the print side by pulling gradually, removing the liner. The unfolding is stopped when a clear film end is seen on top of the drape liner. The drape is positioned and adhered to the patient over the intended incision site, incorporating the marked skin swab site. The Ioban will be applied without wrinkles, but without excessive tension which can cause the Ioban at the wound edge to lift off the applied skin. Using a sterile towel or well-folded abdo guaze, the film is pressed down firmly on the skin (which may be enhanced with a third person doing this), with first contact along the intended incision lie to ensure good adherence as shown. The film is firmly smoothened but without tension to achieve as wrinkle-free adhesion as possible. Thereafter, the rest of the white liner is removed and discarded. The printed paper liner is removed by placing the thumb on the corner of the film and peeling with the other hand. The incision will be made through the IIID and throughout the length of the surgery, the wound edges will be monitored for any elevation of the adhesive incise drape off the skin. The intraoperative peeling of the IIID can lead to bacteria contamination. 42
Control Group No incised drape None Same as the intervention group No description is applicable here is this is the control group 42 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting adult patients aged 18 - 80years, scheduled for cranial or spine surgeries within the limits of the calculated sample size. • Patients with open traumatic wounds at the operation site • Patients with active infection • Patients requiring re-operation in whom the previous wounds have not healed • Patients with uncontrolled medical risk factors for developing infections, including diabetes mellitus • Active smokers • Patients with allergy to iodine and those who develop allergy following the application of IIID • Patients in whose surgery there was a breach of asepsis • Procedures lasting less than 30 minutes from the completion of skin preparation to the completion of wound closure Adolescent: 13 Year-18 Year,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 03/07/2023 Obafemi Awolowo University Teaching Hospitals Complex
Ethics Committee Address
Street address City Postal code Country
Ilesa road Ile Ife 220212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Bacterial skin recolonization measured as colony forming units. At the beginning and end of surgery
Secondary Outcome Surgical site infection 30 days after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Ilesa road Ile Ife 220212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Simon Balogun Ilesa road Ile Ife 220212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Simon Balogun Ilesa road Ile Ife 220212 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Simon Balogun simbal05@yahoo.com +2347031542616 Ilesa road
City Postal code Country Position/Affiliation
Ile Ife 220212 Nigeria Principal Investigation
Role Name Email Phone Street address
Scientific Enquiries Edward Komolafe eokomolafe@hotmail.com +23480334473 Ilesha road
City Postal code Country Position/Affiliation
Ile Ife 220212 Nigeria Professor and Unit head
Role Name Email Phone Street address
Public Enquiries Chizowa Ezeaku ezeakuchizowa@gmail.com +2348080054944 Ilesa road
City Postal code Country Position/Affiliation
Ile Ife 220212 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be made available upon request up to 5yrs after the completion and publication of the study Informed Consent Form,Statistical Analysis Plan,Study Protocol From completion of the study up to 5yrs after the completion and publication of the study Data will be made availabel after it has been de-identified. Subject privacy will be protected
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 08/08/2025 Requested by reviewer EFFECT OF IODOPHOR-IMPREGNATED INCISE DRAPE ON SKIN BACTERIAL RE-COLONIZATION AND SURGICAL SITE INFECTIONS FOLLOWING OPEN BRAIN AND SPINE SURGERIES Effect of iodophor-impregnated incise drape on skin bacterial recolonization and surgical site infections following open brain and spine surgeries
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 08/08/2025 Requested by reviewer EFFECT OF IODOPHOR-IMPREGNATED INCISE DRAPE ON SKIN BACTERIAL RE-COLONIZATION AND SURGICAL SITE INFECTIONS FOLLOWING OPEN BRAIN AND SPINE SURGERIES Effect of iodophor-impregnated incise drape on skin bacterial recolonization and surgical site infections following open brain and spine surgeries
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 14/08/2025 PACTR Admin Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)