Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care

NCT ID: NCT05983302

Last Updated: 2024-03-26

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

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2024-03-20

Brief Summary

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The aim of this study is to eliminate the malodorous of chronic wound and increase the chance of the healing of recalcitrant wounds by using the repairing gel (supraz gel) which has the approved components in wound healing and platelet-rich plasma-fibrin glue.

Detailed Description

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The current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) along with the use of the repairing gel which has the approved components on wound healing in patients with chronic wounds and to eliminate the malodorous of chronic wound. This randomized controlled trial is performed on patients with chronic wounds. Patients will be treated with repairing gel (supraz gel) plus PRP-FG dressing (intervention group) or only Supraz gel (intervention group) or only PRP-FG dressing (intervention group) every 48 hours for 8 weeks versus standard of care of treatment (control group: irrigation of wound by normal saline 0.9%).

Conditions

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Wounds and Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Platelet-Rich Plasma-Fibrin Glue

The first intervention group (group A) includes 10 patients with chronic wounds who, despite classic wound irrigation treatment, will be undergoing platelet-rich plasma-fibrin glue intervention for 8 weeks.

Group Type EXPERIMENTAL

Platelet-Rich Plasma-Fibrin Glue

Intervention Type DRUG

The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.

Repairing Gel

The second intervention group (group B) includes 10 patients with chronic wounds who, despite classic wound irrigation treatment, will be undergoing repairing gel intervention for 8 weeks. The components of repairing gel are vitamin A - vitamin C - vitamin B3 - glycine amino acid. - ethanol - collagen - citric acid - glycerin - malic acid - urea - carboxymethyl cellulose - Sodium alginate - Benzoic acid - Allantoin - Bromelain - Methylene blue - Violet dimethyl sulfoxide . The formulation is patented. (PCT, IR108458)

Group Type EXPERIMENTAL

Repairing Gel

Intervention Type DRUG

The second intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel for 8 weeks.

Platelet-Rich Plasma-Fibrin Glue and Repairing Gel

The third intervention group (group C) includes 10 patients with chronic wounds who, despite classic wound irrigation treatment, will be undergoing the repairing gel with approved wound healing components and platelet-fibrin glue for 8 weeks.

Group Type EXPERIMENTAL

Repairing Gel and Platelet-Rich Plasma-Fibrin Glue

Intervention Type DRUG

The third intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel and PRP-FG for 8 weeks.

Classical wound irrigation (control)

For 10 patients with chronic wounds, only classical wound irrigation by normal saline (0.9%) will be continued for 8 weeks.

Group Type EXPERIMENTAL

Classical wound irrigation (control)

Intervention Type OTHER

For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.

Interventions

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Platelet-Rich Plasma-Fibrin Glue

The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.

Intervention Type DRUG

Repairing Gel

The second intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel for 8 weeks.

Intervention Type DRUG

Repairing Gel and Platelet-Rich Plasma-Fibrin Glue

The third intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel and PRP-FG for 8 weeks.

Intervention Type DRUG

Classical wound irrigation (control)

For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.

Intervention Type OTHER

Other Intervention Names

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PRP-FG Supraz Gel Supraz Gel and PRP-FG Control

Eligibility Criteria

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Inclusion Criteria

* Having a single wound on the body that has been at least 3 months old and has not been repaired by wound irrigation with normal saline and changing the dressing
* Having a body mass index of 18-35
* Sign the informed consent by the patient

Exclusion Criteria

* Having concurrent diseases that may cause problems in wound healing, such as cancers, vasculitis, kidney and liver failure, and heart failure
* Taking certain drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role collaborator

Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Daryoush Hamidi Alamdari, PhD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daryoush Hamidi Alamdari, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

George Koliakos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.

Locations

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Medical School, Aristotle University of Thessaloniki

Thessaloniki, , Greece

Site Status NOT_YET_RECRUITING

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, Iran

Site Status RECRUITING

Countries

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Greece Iran

Central Contacts

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Daryoush Hamidi Alamdari, Ph.D

Role: CONTACT

+98 9151017650

Elaheh Emadi, Ph.D

Role: CONTACT

+98 9355850931

Facility Contacts

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George Koliakos, MD, PhD

Role: primary

00306944677745

Daryoush Hamidi Alamdari, Ph.D

Role: primary

00989151017650

Elaheh Emadi, Ph.D

Role: backup

98 9355850931

Other Identifiers

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IR.MUMS.REC.1402.089

Identifier Type: -

Identifier Source: org_study_id

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