Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Project no.: 10-03-16-40
Study information
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
Acronym
LSME
Study hypothesis
To investigate effects of LigaSure™ with monopolar electrocautery on wound healing in the early post-operative period after pilonidal sinus surgery.
Ethics approval
Eskiºehir Osmangazi University Research Council and Local Ethics Committee approved on the 21st May 2010 (ref: 10-03-16-40)
Study design
Prospective randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/12/2009
Overall trial end date
30/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128
Participant exclusion criteria
1. Declining to participate in the study
2. Having prior surgery for the disease
3. Found to have abscess and infection
Recruitment start date
01/12/2009
Recruitment end date
30/08/2010
Locations
Countries of recruitment
Turkey
Trial participating centre
Adana Teaching and Research Center
Adana
01250
Turkey
Sponsor information
Organisation
Başkent University (Turkey)
Sponsor details
Dadaloglu mah. 39. sok
No:6 Yuregir
Adana
01250
Turkey
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Turkey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21825897
Publication citations
-
Results
Parlakgumus A, Ezer A, Caliskan K, Emeksiz S, Karakaya J, Colakoglu T, Belli S, Yildirim S, Effects of a tissue sealing-cutting device versus monopolar electrocautery on early pilonidal wound healing: a prospective randomized controlled trial., Dis. Colon Rectum, 2011, 54, 9, 1155-1161, doi: 10.1097/DCR.0b013e318222e334.