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 |
| Secondary identifying numbers | Project no.: 10-03-16-40 |
- 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
Scientific
Adana Teaching and Research Center
General Surgery Department
Adana
01250
Türkiye
Study information
| Study design | Prospective randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/12/2009 |
| Completion date | 30/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
01250
Türkiye
Sponsor information
Başkent University (Turkey)
University/education
University/education
Dadaloglu mah. 39. sok
No:6 Yuregir
Adana
01250
Türkiye
| Website | http://www.baskent.edu.tr/ |
|---|---|
"ROR" |
https://ror.org/02v9bqx10 |
Funders
Funder type
Other
Investigator initiated and funded (Turkey)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No |
