Trial Outcomes & Findings for Interest in the Use of Dressings With Honey for Wound Healing After Excision of Pilonidal Cyst (NCT NCT02485860)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

890 participants

Primary outcome timeframe

from randomization to 180 days maximum

Results posted on

2025-12-02

Of 890 enrolled participants, 100 met inclusion criteria and were randomized to treatment

Participant milestones
Measure	Standard dressings Algosteril® + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam	Standard dressings with sterile honey Melectis G
Overall Study STARTED	50	50
Overall Study COMPLETED	44	47
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal
Measure	Standard dressings Algosteril® + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam	Standard dressings with sterile honey Melectis G
Overall Study Lost to Follow-up	4	1
Overall Study Physician Decision	1	2
Overall Study Health context (COVID-19)	1	0

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Standard Dressings n=50 Participants Algosteril® (round or flat wick) + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam	Standard Dressings With Sterile Honey n=50 Participants Melectis G	Total n=100 Participants Total of all reporting groups
Age, Continuous	25 Years STANDARD_DEVIATION 8 • n=50 Participants	24 Years STANDARD_DEVIATION 8 • n=50 Participants	24 Years STANDARD_DEVIATION 8 • n=100 Participants
Sex: Female, Male Female	24 Participants n=50 Participants	19 Participants n=50 Participants	43 Participants n=100 Participants
Sex: Female, Male Male	26 Participants n=50 Participants	31 Participants n=50 Participants	57 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

Timeframe: from randomization to 180 days maximum

Outcome measures
Measure	Standard dressings n=50 Participants Algosteril® + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam	Standard dressings with sterile honey n=50 Participants Melectis G
Healing Time	78 Days Standard Deviation 55	61 Days Standard Deviation 44

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events
Measure	Standard dressings n=50 participants at risk Algosteril® + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam	Standard dressings with sterile honey n=50 participants at risk Melectis G
Infections and infestations Pilonidal cyst with abscess	2.0% 1/50 • From inclusion to the end of follow-up (D180 or healing)	0.00% 0/50 • From inclusion to the end of follow-up (D180 or healing)

Other adverse events
Measure	Standard dressings n=50 participants at risk Algosteril® + Mepilex® border or AquacelTM ExtraTM + AquacelTM Foam	Standard dressings with sterile honey n=50 participants at risk Melectis G
General disorders Application site haemorrhage	16.0% 8/50 • From inclusion to the end of follow-up (D180 or healing)	28.0% 14/50 • From inclusion to the end of follow-up (D180 or healing)
Injury, poisoning and procedural complications Wound dehiscence	10.0% 5/50 • From inclusion to the end of follow-up (D180 or healing)	26.0% 13/50 • From inclusion to the end of follow-up (D180 or healing)
General disorders Application site pain	8.0% 4/50 • From inclusion to the end of follow-up (D180 or healing)	18.0% 9/50 • From inclusion to the end of follow-up (D180 or healing)
General disorders Application site irritation	2.0% 1/50 • From inclusion to the end of follow-up (D180 or healing)	6.0% 3/50 • From inclusion to the end of follow-up (D180 or healing)
General disorders Application site pruritus	2.0% 1/50 • From inclusion to the end of follow-up (D180 or healing)	12.0% 6/50 • From inclusion to the end of follow-up (D180 or healing)
General disorders Impaired healing	6.0% 3/50 • From inclusion to the end of follow-up (D180 or healing)	6.0% 3/50 • From inclusion to the end of follow-up (D180 or healing)

Centre Hospitalier Departemental Vendée

Phone: 02 51 44 61 48