Pilonidal Cysts
Conditions
Keywords
pilonidal cysts, Cavity wound, long healing, honey
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.
Interventions
DEVICEMelectis G
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing Time | from randomization to 180 days maximum |
Countries
France
Participant flow
Pre-assignment details
Of 890 enrolled participants, 100 met inclusion criteria and were randomized to treatment
Participants by arm
| Arm | Count |
|---|---|
| Standard Dressings Algosteril® (round or flat wick) + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam | 50 |
| Standard Dressings With Sterile Honey Melectis G | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Health context (COVID-19) | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Physician Decision | 1 | 2 |
Baseline characteristics
| Characteristic | Standard Dressings | Standard Dressings With Sterile Honey | Total |
|---|---|---|---|
| Age, Continuous | 25 Years STANDARD_DEVIATION 8 | 24 Years STANDARD_DEVIATION 8 | 24 Years STANDARD_DEVIATION 8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 24 Participants | 19 Participants | 43 Participants |
| Sex: Female, Male Male | 26 Participants | 31 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 20 / 50 | 28 / 50 |
| serious Total, serious adverse events | 1 / 50 | 0 / 50 |
Outcome results
Primary
Healing Time
Time frame: from randomization to 180 days maximum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard dressings | Healing Time | 78 Days | Standard Deviation 55 |
| Standard dressings with sterile honey | Healing Time | 61 Days | Standard Deviation 44 |
p-value: 0.094t-test, 2 sided