Condition category
Skin and Connective Tissue Diseases
Date applied
24/10/2010
Date assigned
08/11/2010
Last edited
26/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alper Parlakgumus

ORCID ID

Contact details

Adana Teaching and Research Center
General Surgery Department
Adana
01250
Turkey

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 measures

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

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

http://www.baskent.edu.tr/

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21825897

Publication citations

  1. 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.

Additional files

Editorial Notes