Unroofing Curettage for Pilonidal Disease

Sponsor

Konya Meram State Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05339828

Collaborator

(none)

203

Enrollment

Location

Actual Duration (Days)

772.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to investigate the outcomes of patients who underwent UC as the primary intervention for simple or complex SPD

Condition or Disease	Intervention/Treatment	Phase
Pilonidal Disease Recurrence Healing Wound	Procedure: unroofing curettage

Detailed Description

Sacrococcygeal pilonidal disease (SPD) is a well-known chronic inflammatory condition that affects young adults; There are many treatment options available today, from simple non-surgical methods to extensive flap procedures. However, elaborate treatment strategies can turn this easily treatable disease into a long-term surgical ordeal, causing complications worse than the primary disease itself.

While, UC is considered safe and effective for treating simple SPD, its suitability for treating complex disease is poor and controversial. To date, no studies have investigated the efficacy of UC specifically when treating complex SPD.

This is the first study to identify and compare efficacy and outcomes after UC in patients classified into simple and complex SPD groups.

Study Design

Study Type:

Observational

Actual Enrollment :

203 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Unroofing Curettage for Treating Simple and Complex Sacrococcygeal Pilonidal Disease

Actual Study Start Date :

Apr 27, 2022

Actual Primary Completion Date :

May 2, 2022

Actual Study Completion Date :

May 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
unroofing curettage Surgery was performed with the patient lying in the prone position under local anesthesia. Next, a local anesthetic agent comprising a solution of lidocaine (20 mg/mL) and adrenaline (0.0125 mg/mL) was diluted with distilled water in a 1:2 ratio and applied. The tract was identified by passing small artery forceps along its length and was then opened by cutting directly down onto the forceps. The sinus and all its tracts were completely unroofed, and the base was curetted to remove all necrotic content, hair, and granulation tissue using a dry gauze. The fibrotic back wall was left as intact as possible to avoid delayed healing.	Procedure: unroofing curettage Surgery was performed with the patient lying in the prone position under local anesthesia. The tract was identified by passing small artery forceps along its length and was then opened by cutting directly down onto the forceps. The sinus and all its tracts were completely unroofed, and the base was curetted to remove all necrotic content, hair, and granulation tissue using a dry gauze. The fibrotic back wall was left as intact as possible to avoid delayed healing. Hemostasis was achieved using diathermy with no drainage needed.

Arm

Intervention/Treatment

unroofing curettage

Surgery was performed with the patient lying in the prone position under local anesthesia. Next, a local anesthetic agent comprising a solution of lidocaine (20 mg/mL) and adrenaline (0.0125 mg/mL) was diluted with distilled water in a 1:2 ratio and applied. The tract was identified by passing small artery forceps along its length and was then opened by cutting directly down onto the forceps. The sinus and all its tracts were completely unroofed, and the base was curetted to remove all necrotic content, hair, and granulation tissue using a dry gauze. The fibrotic back wall was left as intact as possible to avoid delayed healing.

Procedure: unroofing curettage

Surgery was performed with the patient lying in the prone position under local anesthesia. The tract was identified by passing small artery forceps along its length and was then opened by cutting directly down onto the forceps. The sinus and all its tracts were completely unroofed, and the base was curetted to remove all necrotic content, hair, and granulation tissue using a dry gauze. The fibrotic back wall was left as intact as possible to avoid delayed healing. Hemostasis was achieved using diathermy with no drainage needed.

Outcome Measures

Primary Outcome Measures

Recurrence [15 days]
After healing was complete, any new sinus orifice or discharge from the wound was defined as disease recurrence.

Secondary Outcome Measures

complete healing time [15 days]
time after surgery until the wound is completely epithelialized
VAS pain score [15 days]
Visual analog scale for pain
time to return to daily activities [15 days]
time after surgery until the to return to daily activities

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Consecutive patients aged 18 years or older

Exclusion Criteria:

acute pilonidal abscess
poorly controlled
diabetes mellitus,
immunosuppressive or coagulation disorders,
pregnancy and/or lactation,
other acute surgical diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Konya Training and Research Hospital	Konya		Turkey	42090

Sponsors and Collaborators

Konya Meram State Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Alpaslan Şahin, Head of Burn Center, Konya Meram State Hospital

ClinicalTrials.gov Identifier:

NCT05339828

Other Study ID Numbers:

Pilonidal Disease surgery

First Posted:

Apr 21, 2022

Last Update Posted:

Jun 28, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alpaslan Şahin, Head of Burn Center, Konya Meram State Hospital

complex pilonidal disease

unroofing curettage

recurrence

Lay open technique

Additional relevant MeSH terms:

Recurrence

Study Results

No Results Posted as of Jun 28, 2022