Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03458663 |
| Other study ID # |
RCTBCL2018 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 14, 2019 |
| Est. completion date |
April 1, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 the treatment is slowly starting to follow.
The estimated incidence is 26 per 100,000 although this is subject to large geographical
variation. Men present themselves with symptomatic pilonidal disease more than twice as often
as women and in population surveys of young students, a 10: 1 male / female ratio has been
found, including also asymptomatic pilonidal cysts. The disorder usually affects the younger
population with average age at first manifestation of 21 years for men and 19 for women.
Acute manifestations are infected and result in pilonidal abscesses. The treatment of acute
abscesses within pilonidal disease is uncontroversial and is based on lateral incision and
drainage with subsequent open healing.
The treatment of chronic pilonidal disease, on the other hand, is still controversial.
Traditional surgical approach is based on excision of the affected tissue with primary
closure or open secondary healing. This treatment, regardless of the manifestation of
disease, is characterized by poor healing, complicated postoperative ulceration and
recurrence.
Since April 2010, there has been a combination and standardization of the treatment of
complicated pilonidal disease at the regional hospital in Randers (Denmark), where patients
with 1) recurrence after previous surgery, 2) missing healing > 2 months after surgery and 3)
extensive / fistulatory pilonidal disease are offered Bascom's cleft lift (BCL ) operation
for the condition.
Bascoms Cleft Lift operation is one of several lateralization techniques that have shown
promising results over the last decades. It has the significant advantage compared to the
other generally accepted surgical lateralization techniques that it only removed a skin patch
(7 mm thick); sub cutis and fat is left in situ regardless of its involvement in the
condition: Crena anii is lifted and lateralized, thereby solving the underlying problem and
preserving most tissues. The intervention should be significantly less painful than other
variants.
In the ongoing work it has been clear that there is delayed healing in a large proportion of
these patients by the scheduled postoperative control 14 days after surgery. During the
experience of the investigators throughout the first 3 years wound healing complications /
delayed healing was found to a variable extent. More than 15% were followed longer than 3
months due to delayed healing and nearly 7% had to be re-operated due to primarily
undermining of the cicatrices.
As the operating results are otherwise promising in these recurrent patients, the
investigators find it relevant to optimize the postoperative course focusing on better
healing.
A vacuum assisted (negative pressure) system, Prevena ™ and ACTIV.A.C ™ therapy system has
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 required. The investigators 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.
Hypothesis
The investigators hypothesize that:
- Patients who have undergone BCL surgery for complicated pilonidal disease have a
significantly better healing using Prevena ™ and ACTIV.A.C ™ Therapy System 4-7 days
post-operatively compared to patients undergoing normal regimen with drainage and
conventional wound dressing.
- That the optimized healing will positively affect the health and wellbeing of patients.
The investigators are not aware of other studies that examine the effect of healing with or
without Prevena ™ and ACTIV.A.C ™ or similar devices or its effects on the quality of life of
these patients.
Purpose of the study
1. To investigate whether Prevena ™ and ACTIV.A.C ™ Therapy System after BCL surgery for
complicated pilonidal disease will improve wound healing compared to a control group of
patients treated with conventional drainage and dressing.
2. To examine whether Prevena ™ and ACTIV.A.C ™ treatment and possibly faster healing after
surgery for PS affects the self-perceived and pain after surgery using questionnaires /
pain journal (Appendix 2 and 3).
3. To describe general health perception among patients with complicated pilonidal disease
before and after Bascom's Cleft Lift operation using a questionnaire regarding pilonidal
disease.
4. To investigate whether postoperative pain after BCL surgery for complicated pilonidal
decreases with Prevena ™ and ACTIV.A.C ™ Therapy System.
Primary end point:
• Evaluate the clinical effect* of Prevena ™ and ACTIV.AC ™ of 4-7 days on BCL cicatrices
after 14 days of healing by the following two criteria*: 1) existence of defects in the
cicatricees (defects ≤ 5 mm considered fully healed) and 2) undermining of the cicatrices.
Secondary end point:
Evaluate the following short and long term results in connection with BCL surgery and the use
of Prevena ™ and ACTIV.A.C ™ Therapy System:
- Symptom related health perception assessed baseline, 14 days postoperatively, after 3
months and after 12 months assessed by questionnaire (Appendix 2)
- Healing after 3 months evaluated according to criteria described above
- Recurrence rate
- Postoperative pain assessed by pain diary (Appendix 3)
