Skip to main content
OpenTrials
Completed

NCT Number: NCT03391310

Use of Honey for Pressure Ulcers in Critically Ill Children

The enrolled children would be randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known as Manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of povidone iodine). Randomization will be performed as per protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure and new onset infection of ulcer.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. John's Medical College, Bengaluru, Karnataka, India

Loading trial locations.

About this study

Children admitted to the PICU would be eligible for inclusion. The interventions will be initiated within the hospital itself. All children will be managed as per standard treatment protocols of the unit for various disease conditions. The enrolled children would be randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known as Manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of povidone iodine). Randomization will be performed as per protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure rate and new onset infection of ulcer. The investigators ICU is a fully equipped 8 bedded ICU with all ventilated beds. There are 2 full time consultants, residents and staff with nurse patient ratio of 1:1 to 1:2. Therefore, the investigators are well equipped to treat critically ill children. There will be an in-built mechanism of assuring quality of processes at different steps.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All children aged <17 years admitted to the ICU and developing any stage of pressure ulcer due to mechanical pressure or device related pressure during the PICU stay will be eligible for the study

Exclusion criteria

Children with pressure ulcers and

  • Who are on more than 1 inotrope would be excluded.
  • Having signs of acute wound infection,
  • Having wounds with > 5 cm diameter,
  • Having allergy to honey and not willing to give consent would be excluded.

Treatment and study plan

Honey (medicated)

Other

Honey (medicated) dressing will be used in the experimental group

Other names: Manuka honey, Leptospermum honey

Primary outcomes

  1. Time to wound healing

    Time frame: Measured upto 12 weeks of onset of ulcer

    Time to healing of stage 1 to 3 of pressure sore

Secondary outcomes

  1. Rate of new onset infection of the wound

    Time frame: Measured upto 1 week of onset of ulcer

    Wound infection

  2. Rate of treatment failure

    Time frame: Measured upto12 weeks of onset of ulcer

    Wound does not heal

  3. Duration of ICU stay

    Time frame: Measured upto 12 weeks of onset of ulcer

    Length of stay in PICU in days

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Collaborators

  • Jawaharlal Institute of Postgraduate Medical Education & Research
  • Post Graduate Institute of Medical Education and Research, Chandigarh

Registry information

Official study title

Use of Honey Versus Standard Treatment for Pressure Ulcers in Critically Ill Children- A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2018
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.