Postoperative Care of Sutured Wounds

NCT ID: NCT02383992

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

3% H2O2 solution

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

0.9% normal saline

Intervention Type DRUG

Interventions

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3% H2O2 solution

Intervention Type DRUG

0.9% normal saline

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU200234

Identifier Type: -

Identifier Source: org_study_id