A randomised prospective study to compare the use of skin staples versus Dermabond tissue adhesive in the management of wound healing in patients undergoing thyroid and parathyroid surgery: a pilot study
| ISRCTN | ISRCTN25938172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25938172 |
| Protocol serial number | N0084144554 |
| Sponsor | Department of Health |
| Funder | Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr P Moore
Scientific
Scientific
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Which method, the use of skin staples or Dermabond is most clinically and cost effective and acceptable to patients undergoing thyroid and parathyroid surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Thyroid and parathyroid |
| Intervention | This study looks at the performance of skin adhesive Dermabond against the standard method of skin closure I.e. skin staples in elective thyroid or parathyroid surgery. If the result of the pilot study show the skin adhesive to be comparable or possibly superior to the staples then it will provide information for the design of a larger study, which will allow thorough statistical analysis of the performance of each method of skin closure. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Patients undergoing elective thyroid or parathyroid surgery under the care of Mr Moore will be invited to take part in the study until a cohort of 30 patients has been recruited. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | Patients who are over the age of 18 years and undergoing thyroid or parathyroid surgery, have no known allergy to the products used in this study. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/11/2002 |
| Date of final enrolment | 30/11/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom
DN15 7BH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/04/2007 | Yes | No |
