Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst

Pilonidal Cysts Clinical Trial

— Pilomiel  

Official title:

Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485860
• Other study ID #: CHD018-15
• Status: Completed
• Phase: Phase 4
• Start date: March 8, 2016
• Est. completion date: February 10, 2022

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The management of pilonidal cysts is a skin excision and under deep skin. Scarring requires regular dressings (daily for 15 days and then every 48 hours) until complete healing. This healing is obtained on average in 68 days. Some patients have difficulties in healing with a final healing achieved on average in 95 days. Some teams use honey to promote wound cavitary wounds (wound infection, pressure ulcers, varicose wound). The acceleration of wound healing is due to antibacterial properties and hyperosmolarity to reduce secretions. ) The use of honey in pilonidal cysts is not evaluated and may accelerate healing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 890
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cavity Wound to 6 weeks of a pilonidal cyst excision

• Bloodless wound

• Pilonidal cyst not recurred

• Age : 18 years and older

• Signature of informed consent

• In the capacity to understand the study

Exclusion Criteria:

• Bleeding wound

• Refused to participate in Protocol

• Patient immunocompromised

• Recurrent pilonidal cyst

• Patients on long-term corticosteroid

• Patient deprived of liberty, under guardianship

• Patient unable to understand the study

• Allergy or hypersensitivity to honey

• Allergy Or hypersensitivity to hyaluronic acid

• Allergy or hypersensitivity to guar gum

• Allergy or hypersensitivity to pectin

• Known allergy to propolis (potentially present in honey)

• Sensitivity to zinc oxide

• Sensitivity known dressings used in this trial or any component

• Diabetes Non-insulin or insulin

Related Conditions & MeSH terms

• Cysts
• Pilonidal Cysts
• Pilonidal Sinus

Intervention

Device:
• Melectis G

Locations

Country	Name	City	State
France	Centre Hospitalier Departemental Vendée	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Time		from randomization to 180 days maximum