Injection of Freshly Collected Autologous Adipose Tissue Additional to Bascom's Cleft Lift Surgery

Launched by UNIVERSITY OF AARHUS · Apr 14, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding injections of a patient’s own fat cells to Bascom's cleft lift surgery can help people with a condition called pilonidal disease heal better after surgery. Pilonidal disease can cause painful cysts near the tailbone, and sometimes surgery is needed to remove them. While Bascom's cleft lift surgery can be effective, some patients experience slow healing. By using their own fat cells, which are taken from another part of the body, the researchers hope to improve healing times and reduce complications.

To be eligible for this trial, participants need to have severe pilonidal disease that requires surgery, or they should have had surgery before without healing properly. They must be able to read and understand Danish, as all information and follow-up will be in that language. Participants who smoke, are pregnant, or have certain health conditions, such as severe diabetes or a very high or low body weight, cannot take part. If you join the study, you will either receive the fat cell injections along with the surgery or just have the surgery alone, and you will be closely monitored during your recovery.

Gender

ALL

Eligibility 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