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

Mashhad University of Medical Sciences

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Wounds and Injuries

Treatments: Drug: Repairing Gel and Platelet-Rich Plasma-Fibrin Glue; Other: Classical wound irrigation (control); Drug: Platelet-Rich Plasma-Fibrin Glue; Drug: Repairing Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05983302

IR.MUMS.REC.1402.089

Details and patient eligibility

About

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.

Full description

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%).

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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40 participants in 4 patient groups

Platelet-Rich Plasma-Fibrin Glue

Experimental group

Description:

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.

Treatment:

Drug: Platelet-Rich Plasma-Fibrin Glue

Repairing Gel

Experimental group

Description:

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)

Treatment:

Drug: Repairing Gel

Platelet-Rich Plasma-Fibrin Glue and Repairing Gel

Experimental group

Description:

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.

Treatment:

Drug: Repairing Gel and Platelet-Rich Plasma-Fibrin Glue

Classical wound irrigation (control)

Experimental group

Description:

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

Treatment:

Other: Classical wound irrigation (control)