ClinicalTrials.Veeva

Menu

Rhomboid Flap vs. Deep Suturing in Recurrent Pilonidal Sinus

A

Assiut University

Status

Not yet enrolling

Conditions

Pilonidal Sinus Infected

Treatments

Procedure: The rhomboid flap approach

Study type

Observational

Funder types

Other

Identifiers

NCT06152952
pilonidal sinus

Details and patient eligibility

About

This prospective clinical trial aims to compare the perioperative outcomes of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.

Full description

Pilonidal disease derives its name from Latin- pilus meaning "hair," and nidus meaning "nest" . The source of pilonidal disease is thought to be a deep intergluteal sulcus. It is widely accepted that the establishment of the pilonidal sinus results from the penetration of shed hair shafts through the skin, which ultimately leads to an acute or chronic infected site .

Pilonidal disease is largely considered a surgical disease, especially in acute instances with secondary infection and abscess. Infection or abscess requires incision and drainage. Definitive treatment is delayed the majority of the time if there is an acute infection or abscess until after the infection has been addressed. Surgical options for chronic disease are numerous and can include "pit picking," curettage, aspiration, unroofing, or surgical excision. Defects can be closed primarily, with flaps or grafts, or allowed to heal by secondary intention .

The most serious problem of the various surgical approaches proposed is the recurrence rate, ranging from 0% to 40% .

The surgical treatment of patients with recurrent disease does not differ from the surgical treatment of primary pilonidal disease. In case of a recurrence with an abscess, incision and drainage prevail, while in case of chronic recurrent disease, a flap based procedure may be indicated following sinus excision with scarring, like the rhomboid flap .

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients aged between 18 and 60 years;
  • Patients with one or two small inactive sinuses will be included for easier excisional procedures;
  • Previous intervention for pilonidal disease whether surgical or non-surgical;

Exclusion criteria

1 - Patients with an acute abscess. 2- Patients with mall inactive pilonidal sinus disease. 3- Age beyond the previous limits. 4- Patients with primary pilonidal disease. 5- Refusal to participate in the study. 6- Unfit for anaesthesia and surgery. 7- Patients with malignant neoplasms or inflammatory bowel disease.

Trial design

30 participants in 2 patient groups

Group 1 : The rhomboid flap Approach
Description:
The flap will be dissected deep to the gluteal fascia (subfascial level) so as to raise thick a fasciocutaneous flap. This will assure good vascularity of the flap without dead space. The rhomboid flap (CDEF) will be mobilized from the gluteal fascia and sutured without tension in three layers (gluteal fascia with 2/0 Vicryl, subcutaneous fat with 3/0 Vicryl, and the skin with 4/0 Prolene). As all sides will be equal in length, the flap fits in place without tension. A suction drain will be left behind and the wound will be dressed as usual. Pressure wound dressing will be applied and removed on the third postoperative day.
Treatment:
Procedure: The rhomboid flap approach
Group 2 : The deep suturing approach
Description:
A vertical elliptical incision encompassing all pilonidal pits will be made and excision of the sinus will be carried out down to the level of the sacrococcygeal fascia. Tension will be released by a limited sharp dissection above the fascia. After haemostasis is ensured using electrocautery, a suction drain will be inserted through a separate incision, then the deep fascia will be approximated and the wound will be closed in layers using polyglactin 0 sutures. Finally, the skin will be closed with 2/0 polypropylene interrupted mattress sutures.
Treatment:
Procedure: The rhomboid flap approach

Trial documents
1

Trial contacts and locations

0

Loading...

Central trial contact

Ahmed Dify, G.P.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems