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

NCT03458663 | Terminated DMC

• 1 other identifier: RCTBCL2018
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Primary healing

  Evaluation of 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.

  14 days after surgery

Secondary Outcomes (4)

• Health perception

  upto 12 months after surgery

• Long term healing

  3 months after surgery

• early recurrence

  up to 12 months after surgery

• post operative pain

  14 days after surgey

Study Arms (2)

Prevena

EXPERIMENTAL

Patients randomized to application of Prevena ™ and ACTIV.A.C ™ Therapy System 4-7 days post-operatively. Patients will return to the surgical day clinic to have the system removed either at day 7 or when/ if function ceases. Patients receive 3 days oral antibiotics postoperatively (Ciproxin 250 mg x 2 and Metronidazole 500 mg x 3). Sutures are removed at clinical control after 14 days and patients are seen again by BCL surgeon after 3 months and are discharged when completely healeddrainage and conventional wound dressing

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

Conentional postoperative care

NO INTERVENTION

patients randomized to convetional postoperative regime with a penrose drain (passive) and a dry draping for 24 hours and after usage of sanitary pads. Patients receive 3 days oral antibiotics postoperatively (Ciproxin 250 mg x 2 and Metronidazole 500 mg x 3). Drain is removed after 24 hours and Sutures are removed at clinical control after 14 days and patients are seen again by BCL surgeon after 3 months and are discharged when completely healeddrainage and conventional wound dressing.

Interventions

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

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.

Prevena

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Randers Regional Hospital: collaborator

Study Sites (1)

Regions Hospitalet Randers

Randers, Jylland, 8930, Denmark

Location

Study Officials

• susanne Haas

  Clinical officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be seen and the primary outcome assesed by a nurse in the out patient department who is blinded to the postoperative care the patient has recieved.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blinded, randomized controlled trial .

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: January 14, 2019
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)