Injection of fat cells to improve healing after pilonidal disease surgery
Examining the Effect of Additional Injection of Freshly Collected Autologous Adipose Tissue to Bascom's Cleft Lift Surgery in the Treatment of Pilonidal Disease- a Randomized Controlled Trial
This study is testing if injecting fat cells during surgery for pilonidal disease can help patients heal faster and reduce pain compared to just the surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Randers, Jylland) |
| Trial ID | NCT05830734 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of injecting freshly harvested autologous adipose tissue in conjunction with Bascom's cleft lift surgery for treating complex or recurrent pilonidal disease. The study aims to determine if this additional treatment can reduce the incidence of prolonged postoperative healing compared to surgery alone. It employs a double-blinded randomized controlled design, focusing on healing outcomes, postoperative pain, complication rates, and recurrence rates over specified follow-up periods. The primary endpoint is the healing of the pilonidal lesion after 4 and 12 weeks post-surgery.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced pilonidal disease requiring Bascom's cleft lift surgery, particularly those with extensive manifestations or previous surgical failures.
Not a fit: Patients with acute infections, pregnancy, or certain health conditions such as insulin-dependent diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce healing times and complications for patients undergoing surgery for pilonidal disease.
How similar studies have performed: While the use of autologous fat cell transplantation is gaining interest, this specific approach in the context of pilonidal disease is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Advanced pilonidal disease with indication for surgery with Bascom's cleft lift surgery due to either 1. Primary extensive manifestation where minimally invasive surgery is not possible 2. Lack of healing after previous surgery (\> 2 months) 3. Recurrence after previous elective surgery * Informed and written consent, as well as consent for follow-up. * Danish speaking/reading and thus able to understand Danish patient information, questionnaires and the pleje.net system. Exclusion Criteria: * Acute infection in pilonidal disease * Pregnancy * BMI \<20 and \>35 * Smokers (stop smoking at least 6 weeks before and after the operation) * Insulin-dependent diabetes * Age \<15 years * Bilateral extension not suitable for BCL surgery
Where this trial is running
Randers, Jylland
- Regions Hospitalet Randers — Randers, Jylland, Denmark (Recruiting)
Study contacts
- Study coordinator: Ida Faurschou, MD
- Email: idafau@rm.dk
- Phone: 28707759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.