Wound HealingNCT02383992
Postoperative Care of Sutured Wounds
A study testing 3% H2O2 solution and 0.9% normal saline in people with Wound Healing, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective of this study is to compare the efficacy of hydrogen peroxide versus normal saline in postoperative care of sutured wounds. Subjects will be randomly assigned to standard of care hydrogen peroxide or standard of care normal saline in postoperative care of sutured wounds followed by applying… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- 3% H2O2 solution and 0.9% normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 1 Oct 2019
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are undergoing sutured wound after dermatologic procedure.
- Males and females ages 18-65 years old.
- Patients who are in good health.
- Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff.
Who cannot join
- History of keloids or hypertrophic scars.
- History of bleeding tendency or coagulopathy.
- Pregnant or lactating or intends to become pregnant in the next 3 months.
- Active skin disease or skin infection in the treatment area.
- Unable to understand the protocol or to give informed consent.
- Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Comparing the Efficacy of Hydrogen Peroxide Versus Normal Saline in Postoperative Care of Sutured Wounds
The primary objective of this study is to compare the efficacy of hydrogen peroxide versus normal saline in postoperative care of sutured wounds. Subjects will be randomly assigned to standard of care hydrogen peroxide or standard of care normal saline in postoperative care of sutured wounds followed by applying petroleum jelly and sterile gauze bandage. Data will be collected at day 0 and between days 7 to14. Subjects will provide irritation scale rating (0-4) with 0 being none/absent and 4 being severe/extreme.
- Conditions
- Wound Healing
- Being tested
- 3% H2O2 solution, 0.9% normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% H2O2 solutionDrug
0.9% normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen Peroxide | Active comparator | Post-operative wound will be treated with 3% H2O2 solution, Subjects will also clean the sutured wounds with 3% H2O2 solution or twice daily then dress the wounds with petroleum jelly and a bandage. Receives: Drug: 3% H2O2 solution |
| Saline | Active comparator | Post-operative wound will be treated with 0.9% normal saline. Subjects will also clean the sutured wounds with normal saline twice daily then dress the wounds with petroleum jelly and a bandage. Receives: Drug: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation scale rating from 1-2 weeks compared to baseline
Subjects will provide irritation scale rating (0-4) with 0 being none/absent and 4 being severe/extreme.
Measured: Baseline and 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startOct 2015
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Why it stopped: Participants never enrolled, study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383992
- Sponsor's protocol ID
- STU200234
- Status last verified
- Dec 2021
- First submitted
- 4 Mar 2015
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Hydrogen Peroxide Versus Normal Saline in Postoperative Care of Sutured Wounds
- ClinicalTrials.gov ID
- NCT02383992
- Acronym / sponsor ID
- STU200234
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Participants never enrolled, study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- 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 primary objective of this study is to compare the efficacy of hydrogen peroxide versus normal saline in postoperative care of sutured wounds. Subjects will be randomly assigned to standard of care hydrogen peroxide or standard of care normal saline in postoperative care of sutured wounds followed by applying petroleum jelly and sterile gauze bandage. Data will be collected at day 0 and between days 7 to14. Subjects will provide irritation scale rating (0-4) with 0 being none/absent and 4 being severe/extreme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrogen Peroxide | Active comparator | Drug: 3% H2O2 solutionPost-operative wound will be treated with 3% H2O2 solution, Subjects will also clean the sutured wounds with 3% H2O2 solution or twice daily then dress the wounds with petroleum jelly and a bandage. |
| Saline | Active comparator | Drug: 0.9% normal salinePost-operative wound will be treated with 0.9% normal saline. Subjects will also clean the sutured wounds with normal saline twice daily then dress the wounds with petroleum jelly and a bandage. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are undergoing sutured wound after dermatologic procedure.
- Males and females ages 18-65 years old.
- Patients who are in good health.
- Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff.
Key exclusion criteria (6 listed)
- History of keloids or hypertrophic scars.
- History of bleeding tendency or coagulopathy.
- Pregnant or lactating or intends to become pregnant in the next 3 months.
- Active skin disease or skin infection in the treatment area.
- Unable to understand the protocol or to give informed consent.
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 |
|---|---|---|
| 3% H2O2 solution | Drug | Hydrogen Peroxide |
| 0.9% normal saline | Drug | Saline |
Primary outcome
Irritation scale rating from 1-2 weeks compared to baseline
Time frame: Baseline and 1-2 weeks
Subjects will provide irritation scale rating (0-4) with 0 being none/absent and 4 being severe/extreme.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
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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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3% H2O2 solution and 0.9% normal saline in people with Wound Healing, run by Northwestern University at 1 site in United States.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 23 Dec 2021. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Irritation scale rating from 1-2 weeks compared to baseline (time frame: Baseline and 1-2 weeks). 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 23 Dec 2021.