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

C

Centre Hospitalier Departemental Vendee

Status and phase

Completed
Phase 4

Conditions

Pilonidal Cysts

Treatments

Device: Melectis G

Study type

Interventional

Funder types

Other

Identifiers

NCT02485860
CHD018-15

Details and patient eligibility

About

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.

Enrollment

890 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

890 participants in 2 patient groups

standard dressings
No Intervention group
Description:
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 group
Description:
Melectis G
Treatment:
Device: Melectis G

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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