Contact information
Type
Scientific
Primary contact
Dr Shin Yan Man
ORCID ID
Contact details
Accident and Emergency Medicine Academic Unit
Faculty of Medicine
The Chinese University of Hong Kong
Shatin
NT
-
Hong Kong
mansy@netvigator.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
03040071
Study information
Scientific title
Acronym
RCTWOUND
Study hypothesis
We hypothesised that although 2-octyl cyanoacrylate tissue adhesive is 15 to 20 times more expensive than suture in Hong Kong, that when all relevant costs were taken into consideration, that tissue adhesive would be the more cost-effective option.
Ethics approval
Ethical approval was obtained from the joint institutional research ethics committees of the Chinese University of Hong Kong and the Prince of Wales Hospital and from the research ethics committee of PYNEH on the 5th July 2005 (ref: CRE-2003.348 and CRE-2003.348-T).
Study design
A non-blinded, randomised controlled trial in the Emergency Departments (EDs) of two acute hospitals in Hong Kong.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Simple laceration wound repair
Intervention
Patients were randomly allocated to one of the two treatment groups using a computer generated randomised number system. One group received suturing materials (4-0 to 6-0 monofilament suture, Tyco Healthcare UK Ltd) and the other group received tissue adhesive (2-octyl cyanoacrylate, Ethicon Inc.) for wound closure. A nurse on clinical duty opened a pre-coded envelope with details about treatment allocation and instructions on wound management.
All wounds were prepared in the same manner (cleansed with normal saline solution) before suturing or applying tissue adhesive. For the suture group, the wound was infiltrated with local anaesthetic (1% lignocaine solution) and the skin was closed using standard techniques with 4-0 to 6-0 monofilament suture. For the tissue adhesive group, local anaesthesia was not required for the procedure. 2-octyl cyanocrylate was painted over the apposed wound edges and 30 seconds were allowed for polymerisation to complete. Both treatment procedures were performed by nurses in EDs whom had been trained in the use of tissue adhesive by the principal investigator.
The duration for wound closure with suture and tissue adhesive are between 10 to 20 minutes. Participants will have follow-up at day 14, 30 and 90 after wound closure.
Intervention type
Drug
Phase
Not Specified
Drug names
2-octyl cyanoacrylate tissue adhesive
Primary outcome measures
The primary outcome measure was the Cosmetic Visual Analogue Scale (CVAS) score, measured at baseline, day 14, 30 and 90.
Secondary outcome measures
Secondary outcome measures included:
1. Visual Analogue Scale (VAS) score, measured at baseline, day 14, 30 and 90
2. Wound Evaluation Scale (WES) score, measured at day 14
3. Total time spent in each closure method
4. The overall patients' satisfaction, measured at day 30
5. The total costs required per patient in each method
Overall trial start date
01/10/2005
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All patients aged greater than or equal to 18 years presenting to the ED between 9 am to 5 pm, Monday to Friday, with traumatic lacerations or incised wounds were eligible for the study.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60 patients for each group
Participant exclusion criteria
To standardise the recruited cases for comparison, wounds with the following features were excluded:
1. Wound length greater than 8 cm
2. Deep wounds with muscle, tendon, bone, joint or neurovascular structure involvement
3. Scalp wounds
4. Vermilion border involvement at lip
5. Stellate lacerations
6. Stab wounds to the trunk or neck
7. Heavily contaminated or infected wounds
8. Animal or human bite
9. Wounds which required debridement of devitalised tissue
10. Wounds in which haemostasis could not be achieved within 20 minutes by direct pressure
11. Wounds greater than 12 hours old
12. We also excluded patients with a history of keloid formation or with physical or cognitive impairment making the use of visual analogue scales inaccurate
Recruitment start date
01/10/2005
Recruitment end date
31/07/2006
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Accident and Emergency Medicine Academic Unit
Shatin, NT
-
Hong Kong
Sponsor information
Organisation
The Health and Health Services Research Fund (HHSRF) (Hong Kong)
Sponsor details
Research Fund Secretariat
Research Office
Food and Health Bureau
18/F
Murray Building
Garden Road
Central
-
Hong Kong
rfs@fhb.gov.hk
Sponsor type
Government
Website
http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html
Funders
Funder type
Government
Funder name
This study was supported by the Health and Health Services Research Fund (HHSRF) (Hong Kong) (project code 03040071).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary