A Phase 4 interventional study of Melectis G in Pilonidal Cysts, sponsored by Centre Hospitalier Departemental Vendee. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Centre Hospitalier Departemental Vendee · Phase 4, Interventional, and Treatment
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's enrollment of 890 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Centre Hospitalier Departemental Vendee is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In general, the dressings made are either of the type : * Algosteril® (round or flat wick) + Mepilex® border * or AquacelTM ExtraTM + AquacelTM Foam
Melectis G
Device: Melectis G
Healing Time
Time frame: from randomization to 180 days maximum
| Milestone | Standard dressings | Standard dressings with sterile honey |
|---|---|---|
| Started | 50 | 50 |
| Completed | 44 | 47 |
| Not completed | 6 | 3 |
| Withdrew: Lost to follow-up | 4 | 1 |
| Withdrew: Physician decision | 1 | 2 |
| Withdrew: Health context (covid-19) | 1 | 0 |
| Days | Standard dressings | Standard dressings with sterile honey |
|---|---|---|
| Healing Time | 78 ± 55 | 61 ± 44 |
Collected over From inclusion to the end of follow-up (D180 or healing). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard dressings | 0/50 (0%) | 1/50 (2%) | 20/50 (40%) |
| Standard dressings with sterile honey | 0/50 (0%) | 0/50 (0%) | 28/50 (56%) |
| Event | Standard dressings | Standard dressings with sterile honey |
|---|---|---|
| Pilonidal cyst with abscessInfections and infestations | 1/50 | 0/50 |
| Event | Standard dressings | Standard dressings with sterile honey |
|---|---|---|
| Application site haemorrhageGeneral disorders | 8/50 | 14/50 |
| Wound dehiscenceInjury, poisoning and procedural complications | 5/50 | 13/50 |
| Application site painGeneral disorders | 4/50 | 9/50 |
| Application site pruritusGeneral disorders | 1/50 | 6/50 |
| Application site irritationGeneral disorders | 1/50 | 3/50 |
| Impaired healingGeneral disorders | 3/50 | 3/50 |
| Age, Continuous(Years) | Standard Dressings | Standard Dressings With Sterile Honey | Total |
|---|---|---|---|
| Mean | 25 ± 8 | 24 ± 8 | 24 ± 8 |
| Sex: Female, Male(Participants) | Standard Dressings | Standard Dressings With Sterile Honey | Total |
|---|---|---|---|
| Female | 24 | 19 | 43 |
| Male | 26 | 31 | 57 |
| Race and Ethnicity Not Collected(Participants) | Standard Dressings | Standard Dressings With Sterile Honey | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Centre Hospitalier Departemental Vendee