Cost-effectiveness analysis of 2-octyl cyanoacrylate tissue adhesive and suture for closure of simple lacerations: Randomised Controlled Trial
| ISRCTN | ISRCTN87805481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87805481 |
| Secondary identifying numbers | 03040071 |
- Submission date
- 06/08/2007
- Registration date
- 24/08/2007
- Last edited
- 17/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shin Yan Man
Scientific
Scientific
Accident and Emergency Medicine Academic Unit
Faculty of Medicine
The Chinese University of Hong Kong
Shatin, NT
-
Hong Kong
| mansy@netvigator.com |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Cost-effectiveness analysis of 2-octyl cyanoacrylate tissue adhesive and suture for closure of simple lacerations: Randomised Controlled Trial |
| Study acronym | RCTWOUND |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 2-octyl cyanoacrylate tissue adhesive |
| Primary outcome measure | 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 study start date | 01/10/2005 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 60 patients for each group |
| Total final enrolment | 186 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Accident and Emergency Medicine Academic Unit
Shatin, NT
-
Hong Kong
-
Hong Kong
Sponsor information
The Health and Health Services Research Fund (HHSRF) (Hong Kong)
Government
Government
Research Fund Secretariat
Research Office
Food and Health Bureau
18/F, Murray Building
Garden Road
Central
-
Hong Kong
| rfs@fhb.gov.hk | |
| Website | http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html |
Funders
Funder type
Government
This study was supported by the Health and Health Services Research Fund (HHSRF) (Hong Kong) (project code 03040071).
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2009 | 17/05/2019 | Yes | No |
Editorial Notes
17/05/2019: Publication reference and total final enrolment added.
