Study Design
Study Type: Randomized, Double-Blind, Controlled Clinical Trial (RCT), Multicenter.
Study Duration: 14 days of treatment + 4 weeks of follow-up.
Randomization: Randomized Block Design (1:1).
Inclusion Criteria
- Patients aged 18 to 80 years.
- Pressure ulcer grade II, III, or IV (according to NPUAP) at least 4 weeks before study entry.
- Wound size 1 to 15 cm2.
- Patient with stable hemodynamic status.
Exclusion Criteria
- Patients with severe wound infection requiring surgery.
- Patients with severe gangrene or necrosis that cannot be debridement.
- Cancer, immunodeficiency, or advanced renal failure.
Method of Use:
1. First, disinfect and clean the areas around the wound (standard wound washing and controlled debridement).
2. Place the dressing on the wound, making sure that it has maximum contact with the wound.
3. Apply a suitable secondary dressing over this dressing.
4. Every 3-5 days.
5. Store at room temperature and avoid direct sunlight.
Control group (standard dressing)
• Foam or hydrogel dressing, changed every 2-3 days.
• Other wound care is the same as in the experimental group.
- Evaluation of results
- Statistical analysis
Settings and conduct
The study is double-blind and conducted at Iran and Bam University of Medical Sciences .
Participants/Inclusion and exclusion criteria
People with bedsores (pressure ulcers) aged 18 to 80 years with grade II, III, or IV pressure ulcers whose wound diameter is 1-15 square centimeters and who have signed a written informed consent form that allows for follow-up and have the necessary cooperation in taking medication. Having one or more pressure ulcers with the largest wound diameter less than 15 centimeters.
Intervention groups
Experimental group: NWD treatment.
Control group: standard treatment
Main outcome variables
Rate of wound closure during treatment.
Healing time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250610066159N2
Registration date:2025-10-17, 1404/07/25
Registration timing:prospective
Last update:2025-10-17, 1404/07/25
Update count:0
Registration date
2025-10-17, 1404/07/25
Registrant information
Name
Ghazaleh Chizarifard
Name of organization / entity
Bam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7772 7495
Email address
chizarigh@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-11-21, 1404/08/30
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of a Smart Nano-Wound Dressing in Pressure Ulcer Healing: A Randomized Clinical Trial
Public title
Treatment of Pressure Ulcers with Nano-Melissa (Lemon Balm)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pressure ulcers (decubitus ulcers/bedsores)
Participants aged between 18 and 80 years
Participants who are willing and able to comply with the use of the smart wound dressing
Participants who provide signed written informed consent
Exclusion criteria:
Not applicable.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization sequence was generated by an independent statistician using R software. Block randomization with variable block sizes (4 and 6) was applied to prevent predictability. The allocation list was concealed using sequentially numbered, opaque, sealed envelopes (SNOSE). After baseline assessment, each participant’s envelope was opened by a nurse not involved in sequence generation, and the assigned dressing type was applied accordingly. The study was assessor-blinded; outcome assessors and the data analyst were unaware of group allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
A stratified randomization method will be used. Patients will be divided into two groups (intervention and control) based on the presence of pressure ulcers, and randomization within each group will be performed using a pre-prepared randomization list. This list will be generated prior to the start of the study. The principal investigator will introduce the selected patients to the clinical caregiver and the outcome assessor (a nursing specialist), who will be responsible for the process. According to the list, wound treatment will be carried out using either the nano-smart wound dressing or the standard wound dressing.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committees Bam University of Medical Science
Unit 9, No. 42, Maleki Street, East Golbarg, Bagheri Highway, Tehranpars.
City
Tehran
Province
Tehran
Postal code
1651897463
Phone
+98 21 7772 7495
Email
chizarigh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
- Results of the effectiveness of smart nanowound dressing in pressure ulcer healing: a randomized clinical trial
- Results and data will be published after de-identification of individuals.
When the data will become available and for how long
1 year after the end of the study
To whom data/document is available
Researchers and people working in the fields of medicine and medical engineering
Under which criteria data/document could be used
The data will be accessible to other authorized persons upon request and permission from the project implementer.
From where data/document is obtainable
The data will be accessible to the parties upon request from the project administrator.
What processes are involved for a request to access data/document
1- Written request from the project manager
2- Check the applicant's qualifications
3- Approval by the manager and colleagues
4- Send approval and provide access to the applicant