An interventional study of Primary closure and Fistulectomy in Pilonidal Sinus, sponsored by Dimitri Christoforidis. Terminated at 1 site in Switzerland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by Dimitri Christoforidis · Not applicable, Interventional, and Treatment
This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.
This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy)
Group A: excision and paramedian closure according to modified Karydakis technique
Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention
Exclusion Criteria:
Excision of sinus and paramedian closure according to modified Karydakis technique
Procedure: Primary closure
Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention
Procedure: Fistulectomy
Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.
Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines
Complete healing
percentage of complete healing
Time frame: 3 weeks
Time to recovery
Time to completely recovery
Time frame: 12 months
percentage of relapse
percentage of relapse after surgery
Time frame: 12 months
Plan to share: No
This study is terminated, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dimitri Christoforidis