An interventional study of Asymmetric Primary Closure and Additional Skin Excision Technique and Standard Karydakis technique. in Pilonidal Sinus, Pilonidal Disease of Natal Cleft and Surgical Technique, sponsored by Siverek Devlet Hastanesi. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-06.
Sponsored by Siverek Devlet Hastanesi · Not applicable, Interventional, and Treatment
The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.
All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.
In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.
In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.
In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.
Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
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Group 1 were treated with the new technique (Asymmetric Primary Closure and Additional Skin Excision). In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.
Procedure: Asymmetric Primary Closure and Additional Skin Excision Technique
Group 2 were treated with the standard Karydakis technique.
Procedure: Standard Karydakis technique.
In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.
In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method
Early postoperative complications.
wound dehiscence, formation of seroma, hematoma, wound infection
Time frame: 3 years
No study locations are listed for this record.
Plan to share: Yes — The study has been completed. The datas will be shared as an article
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Siverek Devlet Hastanesi