Trials / Completed
CompletedNCT03424057
Asymmetric Primary Closure and Additional Skin Excision Technique.
A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Siverek Devlet Hastanesi · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Asymmetric Primary Closure and Additional Skin Excision 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. |
| PROCEDURE | Standard Karydakis technique. | In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method |
Timeline
- Start date
- 2015-04-15
- Primary completion
- 2016-03-25
- Completion
- 2016-04-15
- First posted
- 2018-02-06
- Last updated
- 2018-02-06
Source: ClinicalTrials.gov record NCT03424057. Inclusion in this directory is not an endorsement.