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
Secondary identifying numbers	NL957 (NTR983)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr A. Deliaert
Scientific

Riemsterweg 29
Bilzen
3740
Belgium

Phone	+32 (0)4 7655 0010
Email	andeliaert8@hotmail.com

Study design	Randomised, double blinded, active controlled, parallel group, trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Triclosan coated sutures
Primary outcome measure	Wound healing: Wound dehiscence and complications are registered.
Secondary outcome measures	Scar quality: 1. Colorimetric measurement one month after surgery. Measurements are performed under standard conditions at four fixed test sites 2. Subjective scar assessment by patients and one primary observer using the Patient and Observer Scar Assessment Scale (POSAS)
Overall study start date	11/07/2006
Completion date	11/08/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Riemsterweg 29

Bilzen
3740
Belgium

University Hospital Maastricht (The Netherlands)
Hospital/treatment centre

Department of Plastic Surgery
Maastricht
6200 MD
Netherlands

Website	http://www.unimaas.nl/
"ROR"	https://ror.org/02d9ce178

Hospital/treatment centre

University Hospital Maastricht (The Netherlands)

No information available

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	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/06/2009	27/10/2021	Yes	No

27/10/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.