Postoperative Care of Sutured Wounds

NCT02383992 | Withdrawn DMC

• 1 other identifier: STU200234
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Drug: 0.9% normal saline

Interventions

3% H2O2 solution DRUG

Hydrogen Peroxide

0.9% normal saline DRUG

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

US (1)