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

NCT05830734 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-04-26

No results posted yet for this study

Summary

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.

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

Sponsors & Collaborators

  • Region Zealand

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • susanne Haas, MD PHD · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-04
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05830734 on ClinicalTrials.gov