Postoperative Care of Sutured Wounds

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.

Study Overview

• Status: Withdrawn
• Conditions: Wound Healing
• Intervention / Treatment: Drug: 3% H2O2 solution; Drug: 0.9% normal saline

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who are undergoing sutured wound after dermatologic procedure.
2. Males and females ages 18-65 years old.
3. Patients who are in good health.
4. Willingness and the ability to understand and provide informed consent and communicate with the investigator/study staff.

Exclusion Criteria:

1. History of keloids or hypertrophic scars.
2. History of bleeding tendency or coagulopathy.
3. Pregnant or lactating or intends to become pregnant in the next 3 months.
4. Active skin disease or skin infection in the treatment area.
5. Unable to understand the protocol or to give informed consent.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hydrogen Peroxide; 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.	Drug: 3% H2O2 solution
Active Comparator: Saline; 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.	Drug: 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 1-2 weeks

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 10, 2015

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: STU200234