Clinical trial · Interventional

De-roofing and Curettage vs WLE for Pilonidal Abscess

De-roofing and Curettage Versus Wide Local Excision for the Treatment of Acute Pilonidal Abscess: A Randomised Controlled Trial

NCT03415347CI-TRIAL-00032580unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Pilonidal disease refers to a common disease affecting mostly young males. It may present as asymptomatic pits, acute and painful abscess formation, or chronic discharging sinuses. There are many treatment options for the latter two manifestations but broadly speaking the surgical treatment of acute pilonidal abscess can fall into three categories: (1) incision and drainage, (2) de-roofing and curettage and (3) wide local excision. The evidence available for the surgical management of acute pilonidal abscess is limited. Previous studies have consistently demonstrated that incision and drainage results in high recurrence rates and should not be considered as the first-line treatment option for the management of acute pilonidal abscess. However, it is not clear whether abscess de-roofing with curettage or wide local excision should be considered as the surgical procedure of choice in acute pilonidal abscess. There has not been a prospective randomised study comparing abscess de-roofing with curettage and wide local excision for acute pilonidal abscess. The ideal surgical procedure would be one that results in the lowest rate of abscess recurrence, treats the underlying pilonidal sinus thereby reducing the need for re-operation but has acceptable post-operative pain, complications and time to complete wound healing.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pilonidal Abscess	—	UNRESOLVED	—
Pilonidal Disease	—	UNRESOLVED	—
Pilonidal Sinus Infected	—	UNRESOLVED	—
Pilonidal Sinus With Abscess	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Abscess de-roofing and curettage	Procedure	—	UNRESOLVED
Abscess wide local excision	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Abscess de-roofing and curettage
description
Abscess de-roofing and curettage. The patient will be placed in the lateral position with the buttocks spread apart using tape. The cleft of the buttocks will be shaved prior to cleaning and preparation of the skin. A spindle-shaped (elliptical) excision will be performed to the lateral aspect of the abscess formation with a scalpel staying away from the midline. Once the pus has been drained through this lateral incision the wound cavity will then be curetted and washed out with hydrogen peroxide. The wound size will be measured by the operating surgeon who will record the maximal length and width of the wound. Once haemostasis (cessation of any bleeding) is achieved the wound will be packed with Kaltostat ribbon and the wound dressed with blue gauze and mefix tape. The wound is therefore left open.
interventionNames
1. Procedure: Abscess de-roofing and curettage
type
ACTIVE_COMPARATOR
label
Abscess wide local excision
description
Wide local excision. Patients will be placed in the prone position with the buttocks spread apart using tape. The cleft of the buttocks will be shaved prior to cleaning and preparation of the skin. Diluted methylene blue will be injected in all visible pits and a wide spindle-shaped (elliptical) midline excision of the skin and the underlying subcutaneous tissue down to the coccygeal (pre-sacral) fascia including all sinuses will be performed with electrocautery. The specimen will be sent for histology as per routine surgical practice. The wound will be washed with hydrogen peroxide. The wound size will be measured by the operating surgeon who will record the maximal length and width of the wound. Once haemostasis (cessation of any bleeding) is achieved the wound will be packed with Kaltostat ribbon and the wound dressed with blue gauze and mefix tape. The wound is therefore left open.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years

Show eligibility criteria text

Inclusion Criteria:

* All patients with acute pilonidal abscess

Exclusion Criteria:

* Patients under the age of 16 years will be excluded.
* Immunocompromised (diabetes mellitus, taking oral steroids or immunosuppressive medication) patients will be excluded.

References

Publications (5)

BACKGROUNDLoganathan A, Arsalani Zadeh R, Hartley J. Pilonidal disease: time to reevaluate a common pain in the rear! Dis Colon Rectum. 2012 Apr;55(4):491-3. doi: 10.1097/DCR.0b013e31823fe06c. No abstract available. PMID 22426275
BACKGROUNDHosseini SV, Bananzadeh AM, Rivaz M, Sabet B, Mosallae M, Pourahmad S, Yarmohammadi H. The comparison between drainage, delayed excision and primary closure with excision and secondary healing in management of pilonidal abscess. Int J Surg. 2006;4(4):228-31. doi: 10.1016/j.ijsu.2005.12.005. Epub 2006 May 22. PMID 17462356
BACKGROUNDVahedian J, Nabavizadeh F, Nakhaee N, Vahedian M, Sadeghpour A. Comparison between drainage and curettage in the treatment of acute pilonidal abscess. Saudi Med J. 2005 Apr;26(4):553-5. PMID 15900358
BACKGROUNDEryilmaz R, Sahin M, Alimoglu O, Kaya B. [The comparison of incision and drainage with skin excision and curettage in the treatment of acute pilonidal abscess]. Ulus Travma Acil Cerrahi Derg. 2003 Apr;9(2):120-3. Turkish. PMID 12836108
BACKGROUNDFahrni GT, Vuille-Dit-Bille RN, Leu S, Meuli M, Staerkle RF, Fink L, Dincler S, Muff BS. Five-year Follow-up and Recurrence Rates Following Surgery for Acute and Chronic Pilonidal Disease: A Survey of 421 Cases. Wounds. 2016 Jan;28(1):20-6. PMID 26824973