Evaluating abdominal binding using kinesiotape to reduce infection after caesarean section

ISRCTN	ISRCTN16510251
DOI	https://doi.org/10.1186/ISRCTN16510251
Secondary identifying numbers	MREC ID 2021113-10747

Submission date: 11/03/2022
Registration date: 20/03/2022
Last edited: 08/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
A caesarean section, or C-section, is an operation to deliver your baby through a cut made in your tummy and womb.
Caesarean delivery related superficial surgical site infection (SSI) rate ranges from 3% to 15% worldwide. SSI after cesarean section is associated with increased maternal illness, prolonged hospital stay, and increased medical costs. The aim is to evaluate abdominal binding using kinesiotape (elastic therapeutic tape) against micropore tape in reducing post Caesarean section SSI.

Who can participate?
Women scheduled for Caesarean section (planned and unplanned) in UMMC

What does the study involve?
The study involves using either kinesiotape or micropore tape (allocated randomly) as abdominal binding in patients post caesarean section and the wound will be assessed by clinical assessment (using the Center for Disease Control (USA) [CDC] SSI criteria) up to hospital discharge and further by phone-based questionnaire on day 15 and day 30.

What are the possible benefits and risks of participating?
Participants should not expect any benefit as it is not known whether the abdominal binding using kinesiotape is helpful in preventing infection of Caesarean wound. There are no expected serious drawbacks anticipated. If, at any time, participant finds it troublesome, she may request to change or remove the tape.

Where is the study run from?
Department of Obstetrics and Gynecology, UMMC (Malaysia)

When is the study starting and how long is it expected to run for?
January 2022 to March 2023

Who is funding the study?
Department of Obstetrics and Gynecology, UMMC (Malaysia)

Who is the main contact?
Dr Noor Raihan binti Md Azmi, noorraihan710@gmail.com

Contact information

Dr Noor Raihan Binti Md Azmi
Principal Investigator

University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Phone	+60 195188160
Email	noorraihan710@gmail.com

Dr Dr Noor Faraain binti Abd Gafar
Principal Investigator

O&G Department
Kompleks Kesihatan Wanita
Pusat Perubatan Universiti Malaya
Kuala Lumpur
59100
Malaysia

Phone	+60 167443989
Email	nofagafar@gmail.com

Prof Peng Chiong Tan
Public

O&G Department
Kompleks Kesihatan Wanita
Pusat Perubatan Universiti Malaya
Kuala Lumpur
59100
Malaysia

ORCID ID	0000-0001-8713-6581
Phone	+60 379492059
Email	pctan@um.edu.my

Study information

Study design	Single centre randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	41338 PIS v2 24Jan2022.pdf
Scientific title	Effectiveness of abdominal binding using kinesiotape on caesarean surgical site infection
Study hypothesis	Abdominal binding will benefit obese women by lifting up the abdominal skin fold at the incision site and disrupting a favourable environment for SSI.
Ethics approval(s)	Approved 07/02/2022, Medical Research Ethics Committee University of Malaya Medical Centre (Lembah Pantai, 59100 Kuala Lumpur, Malaysia; +60379493209/2251; iresearch@ummc.edu.my), ref: 2021113-10747
Condition	Reducing rate of caesarean wound infection
Intervention	Participants will be randomised in the operating theatre during surgery after closure of the skin by opening the lowest number remaining, sealed and opaque envelope. The envelopes will be kept in a known location within obstetric operation theatres in a box with numbered envelopes arranged in sequence. Opened/unsealed envelopes will be discarded. The random allocation sequence will be generated by an investigator with no clinical involvement in the study. Blinding is not possible due to the nature of the intervention. After skin closure during Caesarean section and after vaginal cleansing, the abdominal binding will be applied according to randomization (either use Kinesiotape or sham (micropore) tape). Participants are to remove abdominal binding tape and stop using abdominal binding on day 3 after Caesarean delivery.
Intervention type	Procedure/Surgery
Primary outcome measure	Cumulative SSI rates to day 30 after Caesarean delivery, by clinical assessment (using the Center for Disease Control (USA) [CDC] SSI criteria) up to hospital discharge and further by phone-based questionnaire on day 15 and day 30.
Secondary outcome measures	1. Patient’s satisfaction with abdominal binding using visual numerical rating scale (VNRS) at day 15 and day 30 2. Pain score on mobilisation using visual numerical rating scale (VNRS) at day 1, 15 and 30
Overall study start date	01/01/2022
Overall study end date	14/03/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	870
Participant inclusion criteria	1. Age 18 years and above 2. Scheduled for caesarean section (planned or unplanned) 3. BMI ≥27.5 kg/m² 4. Access to telephone
Participant exclusion criteria	1. Preexisting abdominal skin infection 2. Hypersensitivity to abdominal kinesiotape or micropore 3. Midline skin incision 4. Category 1 (emergent) Caesarean section
Recruitment start date	09/04/2022
Recruitment end date	30/04/2024

Locations

Countries of recruitment

Malaysia

Study participating centre

University of Malaya Medical Centre

Lembah Pantai
Kuala Lumpur
59100
Malaysia

Sponsor information

University Malaya Medical Centre
Hospital/treatment centre

Lembah Pantai
Kuala Lumpur
59100
Malaysia

Phone	+60 379494422
Email	ummc@ummc.edu.my
Website	http://www.ummc.edu.my/#
"ROR"	https://ror.org/00vkrxq08

Funders

Funder type

Hospital/treatment centre

Department of Obstetrics and Gynecology, UMMC

No information available

Results and Publications

Intention to publish date	14/03/2024
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 2	24/01/2022	16/03/2022	No	Yes
Protocol file	version 1	03/11/2021	16/03/2022	No	No

Additional files

41338 PIS v2 24Jan2022.pdf
41338 protocol v1 3nov2021.pdf

Editorial Notes

08/09/2023: Internal review.
29/08/2023: A second principal investigator and a public contact have been added.
14/04/2022: The following changes have been made:
1. The recruitment start date has been changed from 14/03/2022 to 09/04/2022.
2. The recruitment end date has been changed from 14/01/2023 to 30/04/2024.
16/03/2022: Trial's existence confirmed by Medical Research Ethics Committee University of Malaya Medical Centre