NCT02485860

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
890

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

June 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

March 8, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 25, 2023

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

5.9 years

First QC Date

June 26, 2015

Results QC Date

January 11, 2023

Last Update Submit

November 14, 2025

Conditions

Keywords

pilonidal cystsCavity woundlong healinghoney

Outcome Measures

Primary Outcomes (1)

  • Healing Time

    from randomization to 180 days maximum

Study Arms (2)

standard dressings

NO INTERVENTION

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

standard dressings with sterile honey

EXPERIMENTAL

Melectis G

Device: Melectis G

Interventions

standard dressings with sterile honey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Departemental Vendée

La Roche-sur-Yon, 85925, France

Location

Related Publications (1)

  • Abet E, Jean MH, Greilsamer T, Planche L, Maurice F, Brau-Weber AG, Denimal F. The value of honey dressings in pilonidal cyst healing: a prospective randomized single-center trial. Tech Coloproctol. 2023 Sep;27(9):721-727. doi: 10.1007/s10151-022-02740-8. Epub 2023 Jan 4.

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Results Point of Contact

Title
Dr. Emeric ABET
Organization
Centre Hospitalier Departemental Vendée

Study Officials

  • Emeric ABET, PH

    Centre Hospitalier Departemental Vendee

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2015

First Posted

June 30, 2015

Study Start

March 8, 2016

Primary Completion

February 10, 2022

Study Completion

February 10, 2022

Last Updated

December 2, 2025

Results First Posted

October 25, 2023

Record last verified: 2025-11

Locations