Actively Recruiting
Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
Led by Albert Schweitzer Ziekenhuis, Netherlands · Updated on 2025-09-30
58
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve care for patients with complex or recurrent pilonidal sinus disease by developing and implementing a best practice care pathway that includes a standardized cleft lift operation. The main question is whether this approach leads to shorter wound healing times and quicker return to normal activities compared to current standard care using traditional excision techniques. Participants are observed in two groups: one receiving current standard practice care and the other following the best practice care pathway with the standardized Bascom cleft lift operation. The study does not involve experimental drug treatments but focuses on comparing surgical methods and care pathways to evaluate outcomes. During the study, participants will have follow-up visits at 1-3 weeks, 4-6 weeks, and 6 months after surgery, with additional visits if needed. Researchers will assess wound healing time and the time it takes for patients to return to their normal activities. The study monitors participants closely through these visits to gather detailed information on recovery progress.
CONDITIONS
Brief Title
Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 16 years of age and older
- Symptomatic complex or recurrent pilonidal sinus disease
- Planned for surgical treatment
- Signed informed consent
You will not qualify if you...
- Pregnant
- Insufficient understanding of the Dutch language or otherwise unable to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks postoperative
Participants undergo surgery with the Bascom cleft lift procedure and receive immediate post-operative care.
Follow-up visits at 1-3 weeks and 4-6 weeks postoperative
Duration - Up to 6 months postoperative
Participants are monitored for wound healing and return to normal activities during longer-term follow-up.
Follow-up visit at 6 months postoperative; additional visits may be planned if necessary
Trial Site Locations
Total: 1 location
1
Albert Schweitzer ziekenhuis
Dordrecht, Netherlands, 3318AT
Actively Recruiting
Research Team
M
Max Goudberg, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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