Back to resultsPostoperative Care of Sutured Wounds
Primary Purpose
Wound Healing
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3% H2O2 solution
0.9% normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Northwestern University Feinberg School of Medicine, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hydrogen Peroxide
Saline
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02383992
First Posted
March 4, 2015
Last Updated
December 22, 2021
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT02383992
Brief Title
Postoperative Care of Sutured Wounds
Official Title
Comparing the Efficacy of Hydrogen Peroxide Versus Normal Saline in Postoperative Care of Sutured Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Participants never enrolled, study never started.
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrogen Peroxide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
3% H2O2 solution
Intervention Type
Drug
Intervention Name(s)
0.9% normal saline
Primary Outcome Measure Information:
Title
Irritation scale rating from 1-2 weeks compared to baseline
Description
Subjects will provide irritation scale rating (0-4) with 0 being none/absent and 4 being severe/extreme.
Time Frame
Baseline and 1-2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Postoperative Care of Sutured Wounds
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