Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst

NCT ID: NCT02485860

Last Updated: 2025-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

890 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-08

Study Completion Date

2022-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Pilonidal Cysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard dressings

In general, the dressings made are either of the type :

* Algosteril® (round or flat wick) + Mepilex® border
* or AquacelTM ExtraTM + AquacelTM Foam

Group Type NO_INTERVENTION

No interventions assigned to this group

standard dressings with sterile honey

Melectis G

Group Type EXPERIMENTAL

Melectis G

Intervention Type DEVICE

Interventions

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Melectis G

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emeric ABET, PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Departemental Vendee

Locations

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Centre Hospitalier Departemental Vendée

La Roche-sur-Yon, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 36598614 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CHD018-15

Identifier Type: -

Identifier Source: org_study_id

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