The effect of triclosan coated sutures in wound healing: a double blind randomised prospective pilot study
| ISRCTN | ISRCTN32724539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32724539 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NL957 (NTR983) |
| Sponsor | University Hospital Maastricht (The Netherlands) |
| Funder | University Hospital Maastricht (The Netherlands) |
- Submission date
- 16/07/2007
- Registration date
- 16/07/2007
- Last edited
- 27/10/2021
- 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 A. Deliaert
Scientific
Scientific
Riemsterweg 29
Bilzen
3740
Belgium
| Phone | +32 (0)4 7655 0010 |
|---|---|
| andeliaert8@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blinded, active controlled, parallel group, trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effect of triclosan coated sutures in wound healing: a double blind randomised prospective pilot study |
| Study objectives | Triclosan coated sutures might have an positive effect on wound healing and thus can improve scar quality. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Coated sutures, triclosan, vicryl plus, wound healing |
| Intervention | Standard suture on control site versus triclosan coated suture on study site. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Triclosan coated sutures |
| Primary outcome measure(s) |
Wound healing: |
| Key secondary outcome measure(s) |
Scar quality: |
| Completion date | 11/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 26 |
| Total final enrolment | 26 |
| Key inclusion criteria | 1. Women between 16 and 65 years of age with bilateral breast size higher than cup DD 2. Clinical complaints such as intertrigo, head neck and/or shoulder complaints 3. Undergoing a breast reduction |
| Key exclusion criteria | Patients with: 1. Diabetes 2. Skin diseases 3. History of keloid formation 4. Use of corticosteroids and other immunosuppressive medication 5. Metabolic and/or degenerative diseases |
| Date of first enrolment | 11/07/2006 |
| Date of final enrolment | 11/08/2007 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
Riemsterweg 29
Bilzen
3740
Belgium
3740
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2009 | 27/10/2021 | Yes | No |
Editorial Notes
27/10/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
