Single-blinded, Randomized Study Comparing Healing After Bascom's Cleft Lift Operation for Pilonidal Disease With or Without Prevena ™ and ACTIV.A.C ™ Therapy System
Single-blinded, Randomized Study Comparing Healing After Bascom's Cleft Lift Operation for Pilonidal Disease With or Without Prevena ™ and ACTIV.A.C ™ Therapy System
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.
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:
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
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:
Inclusion Criteria:
Exclusion Criteria:
Patients under 18 years of age