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Randomized Trial Comparing Prevena and ActiV.A.C. System to Convetional Care After Bascom's Cleft Lift Surgery

NCT03458663 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2022-05-19

No results posted yet for this study

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 pilonidal disease using Bascoms' Cleft Lift procedure. At the department of surgery at The regional Hospital i Randers Denmark the investigators handle cases from the entire region and have a decent patient volume. The investigators have used Bascoms' Cleft left since 2013 and registered complications and experience wound deshisseance or prolonged healing in approx. 15% causing the investigators to challange the postoperative regime.

Conditions

  • Pilonidal Disease

Interventions

DEVICE

Prevena™ og ACTIV.A.C™ Therapy System.

A vacuum assisted (negative pressure) system, Prevena ™ and ACTIV.A.C ™ therapy system have been developed to maintain drainage on closed incisions. The system also works by altering the cytokine profile locally so that it functions anti-inflammatory, by increasing local growth factors and promoting angiogenesis19. Negative pressure wound management (NPWM) such as Prevena ™ and ACTIV.AC ™ is a widely used tool with many different variations, but the evidence of effect remains sparse and more studies are required20. We believe that in a dry and closed incision such as the one after BCL surgery, in an area exposed to stretching during healing, it must be an advantage of maintaining drainage, reducing the anti-inflammatory response and increasing angiogenesis.

Sponsors & Collaborators

  • Randers Regional Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • susanne Haas · Clinical officer

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2022-03-01
Completion
2022-04-01

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 NCT03458663 on ClinicalTrials.gov