Wound InfectionPhase 2/3NCT06220344
Honey Dressing - A Preventive Procedure for Post-Surgical Site Infection.
A Phase 2/3 study testing Honey Dressing and Iodine Dressing in people with Wound Infection and Wound Dehiscence, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the wound healing in the participants who underwent the clean surgical procedure, by applying honey dressing and common Iodine solution dressing, participants will have no other co-morbidities like Diabetes, Anemia, etc. which can make the results biased. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Wound Infection, Wound Dehiscence, Wound Bleeding
- What is being tested?
- Honey Dressing and Iodine Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Dec 2022to 3 Mar 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with sterile/clean post-surgical wounds are admitted in general surgery, neurosurgery, orthopedic, and gynecology wards and require follow-up dressings.
Who cannot join
- Patients with:
- Anemia
- BMI>30
- Local Infection in wound area.
- Venous leg ulcers
- Diabetes
- Immunocompromised (Oncological patients)
- Patient under negative pressure therapy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Heavy Industry Taxila Hospital
Rawalpindi, Punjab Province, 407070
About this study
Official title: Honey Dressing - A Preventive Procedure for Post-Surgical Site Infection
The goal of this clinical trial is to compare the wound healing in the participants who underwent the clean surgical procedure, by applying honey dressing and common Iodine solution dressing, participants will have no other co-morbidities like Diabetes, Anemia, etc. which can make the results biased. The main questions it aims to answer are:
- Do the iodine solutions are enough to counter the infections caused by resistant strains of bacteria?
- What is the efficacy and efficiency of honey dressing in wound care?
Read more
Participants will be tasked to
- Ensure strict follow-up in the hospital dressing room
- Half of the participants will apply common iodine solution dressing and the other half will be applied honey dressing.
Researchers will compare Iodine dressing (Control group) with Honey dressing (Experimental group) to see if Honey dressing is better in the prevention of post-surgery wound infection and if it is cost-efficient and its efficacy.
- Conditions
- Wound Infection, Wound Dehiscence, Wound Bleeding, Wound Surgical
- Being tested
- Honey Dressing, Iodine Dressing
- Medical subject headings
- Wound Infection, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honey DressingBiological
Honey Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed.
Iodine DressingDrug
Also called Iodine solution dressing
Iodine Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed.
| Study group | Role | What they receive |
|---|---|---|
| Honey | Experimental | Participants will get honey dressings in their follow-up visits to the dressing room. Receives: Biological: Honey Dressing |
| Aseptic Iodine | Active comparator | Participants will get iodine solution dressings in their follow-up visits to the dressing room. Receives: Drug: Iodine Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of Wound Infection
Presence of exudate, warmth, pus, erythema, dehiscence, contact bleeding, and any systemic sign like fever, rash, and myalgia.
Measured: 3rd day, 7th day, 15th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start2 Dec 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Muhammad Ali Haider, HITEC-Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220344
- Sponsor's protocol ID
- HITEC-IMS-01-2022
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Honey Dressing - A Preventive Procedure for Post-Surgical Site Infection
- ClinicalTrials.gov ID
- NCT06220344
- Acronym / sponsor ID
- HITEC-IMS-01-2022
- Conditions
- Wound Infection, Wound Dehiscence, Wound Bleeding, Wound Surgical
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- HITEC-Institute of Medical SciencesUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the wound healing in the participants who underwent the clean surgical procedure, by applying honey dressing and common Iodine solution dressing, participants will have no other co-morbidities like Diabetes, Anemia, etc. which can make the results biased. The main questions it aims to answer are:
- Do the iodine solutions are enough to counter the infections caused by resistant strains of bacteria?
- What is the efficacy and efficiency of honey dressing in wound care?
Participants will be tasked to
- Ensure strict follow-up in the hospital dressing room
- Half of the participants will apply common iodine solution dressing and the other half will be applied honey dressing.
Researchers will compare Iodine dressing (Control group) with Honey dressing (Experimental group) to see if Honey dressing is better in the prevention of post-surgery wound infection and if it is cost-efficient and its efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honey | Experimental | Biological: Honey DressingParticipants will get honey dressings in their follow-up visits to the dressing room. |
| Aseptic Iodine | Active comparator | Drug: Iodine DressingParticipants will get iodine solution dressings in their follow-up visits to the dressing room. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with sterile/clean post-surgical wounds are admitted in general surgery, neurosurgery, orthopedic, and gynecology wards and require follow-up dressings.
Key exclusion criteria (8 listed)
- Patients with:
- Patient under negative pressure therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honey DressingHoney Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed. | Biological | Honey |
| Iodine DressingAlso: Iodine solution dressingIodine Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed. | Drug | Aseptic Iodine |
Primary outcome
Signs of Wound Infection
Time frame: 3rd day, 7th day, 15th day.
Presence of exudate, warmth, pus, erythema, dehiscence, contact bleeding, and any systemic sign like fever, rash, and myalgia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Honey Dressing and Iodine Dressing in people with Wound Infection and Wound Dehiscence, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs of Wound Infection (time frame: 3rd day, 7th day, 15th day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.