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

Primary Purpose

Pilonidal Cysts

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Melectis G
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Cysts focused on measuring pilonidal cysts, Cavity wound, long healing, honey

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Departemental Vendée

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard dressings

standard dressings with sterile honey

Arm Description

In general, the dressings made are either of the type : Algosteril® (round or flat wick) + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam

Melectis G

Outcomes

Primary Outcome Measures

Healing Time

Secondary Outcome Measures

Full Information

First Posted
June 26, 2015
Last Updated
January 11, 2023
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT02485860
Brief Title
Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst
Acronym
Pilomiel
Official Title
Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2016 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Cysts
Keywords
pilonidal cysts, Cavity wound, long healing, honey

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
890 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard dressings
Arm Type
No Intervention
Arm Description
In general, the dressings made are either of the type : Algosteril® (round or flat wick) + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam
Arm Title
standard dressings with sterile honey
Arm Type
Experimental
Arm Description
Melectis G
Intervention Type
Device
Intervention Name(s)
Melectis G
Primary Outcome Measure Information:
Title
Healing Time
Time Frame
from randomization to 180 days maximum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emeric ABET, PH
Organizational Affiliation
Centre Hospitalier Departemental Vendee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Departemental Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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