NCT07456072

Brief Summary

To compare rate of infection and wound healing between chlorhexidine impregnated paraffin gauze and dry povidone-iodine dressings in post-traumatic wounds.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

February 26, 2026

Last Update Submit

March 3, 2026

Conditions

Wound Infection Post-TraumaticWound Healing

Outcome Measures

Primary Outcomes (1)

  • Change in infection rate

    3 months

Secondary Outcomes (1)

  • Change in Wound healing

    3 months

Study Arms (2)

Povidone iodine group

ACTIVE COMPARATOR
Procedure: Povidone iodine dressing

Chlorhexidine impregnated paraffin gauze group

EXPERIMENTAL
Procedure: Chlorhexidine impregnated paraffin gauze

Interventions

Chlorhexidine impregnated paraffin gauzePROCEDURE

Paraffin gauze impregnated with 0.2 % chlorhexidine

Chlorhexidine impregnated paraffin gauze group
Povidone iodine dressingPROCEDURE

Standard povidone iodine dressing

Povidone iodine group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18-65 years of age with acute post-trauma wounds.
  • Wounds that are clean contaminated at presentation.

You may not qualify if:

  • Patients with the known allergies to Chlorhexidine or Povidone-Iodine.
  • Chronic wounds or those with underlying chronic conditions, such as diabetes.
  • Patients with compromised immune systems.
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Resident - Plastic and Burn Reconstructive Surgery Center

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 6, 2026

Study Start

March 1, 2026

Primary Completion

May 31, 2026

Study Completion

May 31, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share