Pilonidal Disease Clinical Trial
Official title:
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
Verified date | April 2023 |
Source | University of Aarhus |
Contact | Ida Faurschou, MD |
Phone | 28707759 |
idafau[@]rm.dk | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In brief, the right management of complex or recurrent pilonidal disease (PD) is still controversial. In our institution we treat these conditions with Bascom's cleft lift surgery. Though this approach for most parts is beneficial, a large proportion of patients will suffer from prolonged post operative healing. We have published some positive results on treating non-healing postoperative wounds after cleft lift surgery with autologous fatty cell transplantation. The overall aim of the project is to investigate whether the addition of autologous fat cell transplantation in the surgical treatment of PD reduces the incidence of patients with prolonged postoperative healing. In a double-blinded randomized controlled clinical trial, we will investigate the effect of injections of freshly harvested autologous fatty cells in addition to Bascom's cleft lift operation versus Bascom's cleft lift operation alone.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | March 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Regions Hospitalet Randers | Randers | Jylland |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Region Zealand |
Denmark,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | healing | Healing of the pilonidal lesion (max 1 defect =5mm, no undermining) | 4 weeks | |
Primary | healing | Healing of the pilonidal lesion (max 1 defect =5mm, no undermining) | 12 weeks | |
Secondary | Symptom development | Symptom questionnaire completed . | pre-operatively, at 4 weeks, 12 weeks and 12 months | |
Secondary | postoperative pain | pain diary. Daily pain measurement on a VAS score (0= no pain, 10= worst imaginable pain) | first 14 postoperative days | |
Secondary | complications | any early or late complications that may arise | 12 weeks | |
Secondary | Time to healing | the patients will be followed weekly with photos in pleje.net until healing has occured | upto 12 months | |
Secondary | recurrence | recurrent disease after complete healing is registered by questionnaire | 12 months | |
Secondary | recurrence | recurrent disease after complete healing is registered by questionnaire | 36 months | |
Secondary | recurrence | recurrent disease after complete healing is registered by questionnaire | 60 months |
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