Pilonidal CystsPhase 4PilomielNCT02485860
Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst
A Phase 4 study testing Melectis G in people with Pilonidal Cysts, run by Centre Hospitalier Departemental Vendee at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Cysts
- What is being tested?
- Melectis G
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 890 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2016to 10 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bleeding wound
- Refused to participate in Protocol
- Patient immunocompromised
- Recurrent pilonidal cyst
- Patients on long-term corticosteroid
- Patient deprived of liberty, under guardianship
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pilonidal Cysts
- Being tested
- Melectis G
- Keywords
- pilonidal cysts, Cavity wound, long healing, honey
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melectis GDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Melectis G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Time
Measured: from randomization to 180 days maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start8 Mar 2016
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pilonidal CystsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeric ABET, PH, Principal investigator, Centre Hospitalier Departemental Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485860
- Sponsor's protocol ID
- CHD018-15
- Acronym
- Pilomiel
- Status last verified
- Nov 2025
- First submitted
- 26 Jun 2015
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36598614
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst
- ClinicalTrials.gov ID
- NCT02485860
- Acronym / sponsor ID
- Pilomiel / CHD018-15
- Conditions
- Pilonidal Cysts
- Keywords
- pilonidal cysts, Cavity wound, long healing, honey
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Posted 25 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Melectis GMelectis G |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- Bleeding wound
- Refused to participate in Protocol
- Patient immunocompromised
- Recurrent pilonidal cyst
- Patients on long-term corticosteroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melectis G | Device | standard dressings with sterile honey |
Primary outcome
Healing Time
Time frame: from randomization to 180 days maximum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36598614Abet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emeric ABET, PH principal investigator
Centre Hospitalier Departemental Vendee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melectis G in people with Pilonidal Cysts, run by Centre Hospitalier Departemental Vendee at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Time (time frame: from randomization to 180 days maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.