Status:
TERMINATED
Randomized Trial Comparing Prevena and ActiV.A.C. System to Convetional Care After Bascom's Cleft Lift Surgery
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Randers Regional Hospital
Conditions:
Pilonidal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In a single-blinded randomized, controlled study design the investigators wish to examine to effect of Prevena + ActiV.A.C. therapy system on the postoperative healing in patients operated for chronic...
Detailed Description
Background Pilonidal disease (PS) is a common disorder that occurs in the crena ani. A paradigm shift of our perception of the pathology of this disorder has been on its way for several decades and th...
Eligibility Criteria
Inclusion
- Patients with recurrence after previous surgery for pilonidal disease, cases of poor postoperative healing (\> two months) or primary extensive/fistulating disease referred to Randers Regional Hospital for assessment for reconstructive BCL surgery.
Exclusion
- Patients under 18 years of age
- Patients who smoke (not offered this type of surgery), ceased min. 6 weeks pre-operatively
- Patients with PS lesions are ≤ 3 cm from the anus
- Patients with allergies to Silver or acrylic
- Patients who cannot adhere to study protocol
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03458663
Start Date
January 14 2019
End Date
April 1 2022
Last Update
May 19 2022
Active Locations (1)
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1
Regions Hospitalet Randers
Randers, Jylland, Denmark, 8930