| - candidate number | 2606 |
| - NTR Number | NTR983 |
| - ISRCTN | ISRCTN32724539 |
| - Date ISRCTN created | 16-jul-2007 |
| - date ISRCTN requested | 9-jul-2007 |
| - Date Registered NTR | 28-mei-2007 |
| - Secondary IDs | N/A |
| - Public Title | The effect of triclosan coated sutures in wound healing. A double blind randomized prospective pilot study. |
| - Scientific Title | The effect of triclosan coated sutures in wound healing. A double blind randomized prospective pilot study in patients ondergoing a breast reduction. |
| - ACRONYM | N/A |
| - hypothesis | Triclosan coated sutures might have an positive effect on wound healing and thus can improve scar quality. |
| - Healt Condition(s) or Problem(s) studied | Wound healing, Triclosan, Coated sutures, Vicryl Plus |
| - 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. |
| - Exclusion criteria | 1. Patients with: a. diabetes; b. skin diseases; c. history of keloid formation; d. use of corticosteroids and other immunosuppressive medication; e. metabolic and/or degenerative diseases. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 11-jul-2006 |
| - planned closingdate | 11-aug-2007 |
| - Target number of participants | 26 |
| - Interventions | Standard suture on control site; triclosan coated suture on study site. |
| - Primary outcome | Wound healing: wound dehiscence and complications are registrated. |
| - Secondary outcome | Scar quality: Colorimetric measurement 1 month after surgery Measurements are performed under standard conditions at 4 fixed test sites. Subjective scar assessement by patients and one primary observer using the POSAS scale. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | A. Deliaert |
| - CONTACT for SCIENTIFIC QUERIES | Dr R.R.W.J. Hulst, van der |
| - Sponsor/Initiator | University Hospital Maastricht, Department of Plastic surgery |
| - Funding (Source(s) of Monetary or Material Support) | University Hospital Maastricht, Department of Plastic surgery |
| - Publications | |
| - Brief summary | Wound infection is a major contributor to postoperative morbidity. One
potential cause or co-factor is the use of suture material. A recently
introduced subcutaneous suture is coated with triclosan (TC), an antiseptic
drug. It is suggested to reduce wound complications and improve scar
quality. Methods: To investigate the effect of TC on wound healing a double blind prospective study in women undergoing a breast reduction was performed. Each patient was her own control. After randomization the TC coated sutures were used either on the left or right side. The contra lateral side was used as the control. The incidence of dehiscence, postoperative redness and subjective parameters of scar quality were studied. |
| - Main changes (audit trail) | |
| - RECORD | 28-mei-2007 - 9-dec-2009 |
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