NCT01399320

Brief Summary

Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity.here we try a minimmally invasive method for managing such condition

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
Last Updated

July 21, 2011

Status Verified

August 1, 2008

Enrollment Period

1.1 years

First QC Date

July 19, 2011

Last Update Submit

July 20, 2011

Conditions

Pilonidal SinusSurgical WoundDressing by Cyanoacrylate

Keywords

Pilonidal diseaseExcisioncyanoacrylate

Outcome Measures

Primary Outcomes (1)

  • healing of the sinus

    1 month

Secondary Outcomes (3)

  • recurrence

    1 year

  • wound infection

    3-6 months

  • patient satisfaction

    3 months

Study Arms (1)

cyanoacrylate dressing,excesion

EXPERIMENTAL

we excise the sinus tip then apply cyanoacrylate dressing and watch for healing

Procedure: cyanoacrylate

Interventions

cyanoacrylatePROCEDURE

excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing

Also known as: histoacryl
cyanoacrylate dressing,excesion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • any patient with pilonidal sinus

You may not qualify if:

  • pilonidal abscess or sever acute inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Faculty of Medicine

Al Mansurah, Dakahlia Governorate, 35665, Egypt

Location

MeSH Terms

Conditions

Pilonidal SinusSurgical Wound

Interventions

CyanoacrylatesEnbucrilate

Condition Hierarchy (Ancestors)

CystsNeoplasmsWounds and Injuries

Intervention Hierarchy (Ancestors)

AcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrilesPolymersMacromolecular SubstancesBiomedical and Dental MaterialsTissue AdhesivesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • wagih m ghnnam, MD

    mansoura faculty of medicine general surgery department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

August 1, 2008

Primary Completion

September 1, 2009

Study Completion

June 1, 2010

Last Updated

July 21, 2011

Record last verified: 2008-08

Locations

EG(1)