Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/08/2007
Date assigned
24/08/2007
Last edited
24/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes