Comparison of effects of LigaSure™ with those of Monopolar Electrocautery on wound healing in early post-operative period after pilonidal sinus surgery

ISRCTN	ISRCTN81456610
DOI	https://doi.org/10.1186/ISRCTN81456610
Protocol serial number	Project no.: 10-03-16-40
Sponsor	Başkent University (Turkey)
Funder	Investigator initiated and funded (Turkey)

Submission date: 24/10/2010
Registration date: 08/11/2010
Last edited: 26/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alper Parlakgumus
Scientific

Adana Teaching and Research Center
General Surgery Department
Adana
01250
Türkiye

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Comparison of effects of LigaSure™ with those of Monopolar Electrocautery on wound healing in early post-operative period after pilonidal sinus surgery: a prospective randomised controlled clinical trial
Study acronym	LSME
Study objectives	To investigate effects of LigaSure™ with monopolar electrocautery on wound healing in the early post-operative period after pilonidal sinus surgery.
Ethics approval(s)	Eskiºehir Osmangazi University Research Council and Local Ethics Committee approved on the 21st May 2010 (ref: 10-03-16-40)
Health condition(s) or problem(s) studied	Sacrococcygeal pilonidal disease
Intervention	Following an incision in the skin, pilonidal sinus excision was performed with monopolar electrocautery in the control group (n = 64) (Group ME) and with LigaSure™ in the study group (n = 64) (Group LS). Demographic variables, history, physical examination findings, defect dimensions and scores for Visual Analogue Scale (VAS) and patient satisfaction were recorded. After collecting the adequate number of subjects at least 3 months of follow-up and for recovery till the wound healing. Nearly 1 year total duration of treatment.
Intervention type	Other
Primary outcome measure(s)	1. Surgical site infections, assessed based on the hospital infection control practices advisory committee guidelines 2. Early wound failure (dehiscence), considered as breakdown and dehiscence of the sutured wound with or without infection 3. Recurrence
Key secondary outcome measure(s)	1. Post-operative use of antibiotics 2. Time to remove sutures 3. Time to wound healing (days), refers to full epithelisation over the wound. When the wound was not healed in the month after surgery, the follow-up of the wound was continued until the wound healed completely. 4. Time to return to all daily activities 5. Time to complete recovery, defined as return to all activities and as complete healing of the wound 6. Patient satisfaction 7. Pain
Completion date	30/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	128
Key inclusion criteria	1. Consecutive patients aged greater than 18 years, either sex 2. Pilonidal disease 3. Considered appropriate for primary closure 4. Giving informed consent
Key exclusion criteria	1. Declining to participate in the study 2. Having prior surgery for the disease 3. Found to have abscess and infection
Date of first enrolment	01/12/2009
Date of final enrolment	30/08/2010

Locations

Countries of recruitment

Türkiye

Study participating centre

Adana Teaching and Research Center

Adana
01250
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?
Results article	results	01/09/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes