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

NARecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

January 4, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2026

Conditions
Pilonidal Disease
Interventions
OTHER

injection of freshly collected adipose cells

"A small incision is made bilaterally in the lumbar region. 2-300 ml of Ringer's acetate with 1 mg of added adrenaline is introduced with an infusion cannula fan-shaped into the subcutaneous adipose tissue on each side of the region.~Adipose tissue is harvested for a total of approx. 80 ml. 20 ml Bupivacaine 5 mg/ml is distributed on each side of the lower back. The incisions are then closed with Steri-Strips and a compressive dressing is applied to reduce the risk of hematoma.~The harvested adipose tissue then centrifuged in bulks of four at 1000 rpm. minute for 3 minutes. The liquid fraction is discarded. Using a three-way tap system, the adipose tissue is microfragmented between two 10 ml syringes by moving the contents back and forth at least 20 times. The adipose tissue is then distributed in 2 ml syringes for injection. A total of between 25 and 55 ml of usable adipose tissue will be harvested."

PROCEDURE

Bascoms Cleft lift procedure

The procedure is carried out according to standardized principles previously decribed by Drs. John and Tom Bascom

Trial Locations (1)

8930

RECRUITING

Regions Hospitalet Randers, Randers

All Listed Sponsors
collaborator

Region Zealand

OTHER

lead

University of Aarhus

OTHER