Comparative study of a barbed suture, polyglecaprone and stapler in Pfannenstiel incisions performed for benign gynaecological procedures

ISRCTN	ISRCTN58129660
DOI	https://doi.org/10.1186/ISRCTN58129660
Protocol serial number	N/A
Sponsor	Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey)
Funder	Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey) - Department of Obstetrics and Gynaecology

Submission date: 08/06/2009
Registration date: 09/07/2009
Last edited: 11/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mehmet Murat Naki
Scientific

Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Türkiye

Email	mmuratnaki@yahoo.com

Study information

Primary study design	Interventional
Study design	Randomised controlled single centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Comparative study of a barbed suture, polyglecaprone and stapler in Pfannenstiel incisions performed for benign gynaecological procedures: a randomised trial
Study objectives	Are there any differences between three suture materials on post-operative incision pain, patient satisfaction and scar cosmesis? Please note that as of 11/02/10 this trial has been updated to included participants aged 18-65.
Ethics approval(s)	Ethics Committee of the Dr. Lutfi Kirdar Kartal Research and Training Hospital approved on the 26th March 2009 (ref: 17/28.05.2009)
Health condition(s) or problem(s) studied	Benign gynaecological diseases/skin incision closure
Intervention	This trial is taking place at the Istanbul Dr. Lutfi Kirdar Kartal Research and Training Hospital, Department of Obstetrics and Gynaecology. Approximately 117 patients will be recruited, 39 patients in each of the following three groups: 1. Skin incision closure with a barbed suture (copolymer of glycolide and e-caprolactone) 2. Skin incision closure with intracutaneous polyglecaprone 3. Skin incision closure with stapler Patient allocation will be carried out as follows: A computer based randomisation will be prepared. The skin closure type will be printed on identical sheets of paper, which will be put into identical, consecutively numbered sealed opaque envelopes by a non-participating colleague.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Pain for skin incision (post-operative third day)
Key secondary outcome measure(s)	1. Patient satisfaction (post-operative sixth day) 2. Scar cosmesis score (post-operative third month)
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Female
Target sample size at registration	117
Key inclusion criteria	1. Women between ages of 18 - 45 years 2. Pfannenstiel incisions for benign gynaecological procedures 3. No previous lower abdominal incision Amended 11/02/10: 1. Women between ages of 18 - 65 years
Key exclusion criteria	1. Previous lower abdominal incision 2. Diabetes mellitus 3. Body mass index more than 35 kg/m^2 4. Chronic alcholism
Date of first enrolment	01/06/2009
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Türkiye

Study participating centre

Cihat Saran Sk. Cagdas Apt. No:11/3

Istanbul
34841
Türkiye

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes