Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard dressings | No Intervention | In general, the dressings made are either of the type :
| |
| standard dressings with sterile honey | Experimental | Melectis G |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melectis G | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing Time | from randomization to 180 days maximum |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emeric ABET, PH | Centre Hospitalier Departemental Vendee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Departemental Vendée | La Roche-sur-Yon | 85925 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36598614 | Result | 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. |
Not provided
Not provided
Of 890 enrolled participants, 100 met inclusion criteria and were randomized to treatment
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard dressings | Algosteril® + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam |
| FG001 | Standard dressings with sterile honey | Melectis G |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dressings | Algosteril® (round or flat wick) + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam |
| BG001 | Standard Dressings With Sterile Honey | Melectis G |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Healing Time | Posted | Mean | Standard Deviation | Days | from randomization to 180 days maximum |
|
|
From inclusion to the end of follow-up (D180 or healing)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard dressings | Algosteril® + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pilonidal cyst with abscess | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site haemorrhage | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emeric ABET | Centre Hospitalier Departemental Vendée | 02 51 44 61 48 | +33 | emeric.abet@ght85.fr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2021 | Jan 11, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Health context (COVID-19) |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 0 |
| 50 |
| 1 |
| 50 |
| 20 |
| 50 |
| EG001 | Standard dressings with sterile honey | Melectis G | 0 | 50 | 0 | 50 | 28 | 50 |
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Application site pain | General disorders | Systematic Assessment |
|
| Application site irritation | General disorders | Systematic Assessment |
|
| Application site pruritus | General disorders | Systematic Assessment |
|
| Impaired healing | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided