Active — Not RecruitingPhase 2/3

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

Iran40 participantsStarted 2023-08-20

Plain-language summary

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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Wound Odor Change

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)

Wound Size Change

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)

Visual Analog Scale changes for pain assessment

Timeframe: Every 48 hours for 8 weeks

Duration of recovery

Timeframe: 8 weeks

Change in the systemic inflammatory marker C-reactive protein (CRP)

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)

Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)

Change in systemic inflammatory marker Interleukin 6 (IL-6)

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)

Trial details

NCT IDNCT05983302

SponsorMashhad University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-20

View on ClinicalTrials.gov More Wounds and Injuries trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Wound Odor Change

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)

Wound Size Change

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)

Visual Analog Scale changes for pain assessment

Timeframe: Every 48 hours for 8 weeks

Duration of recovery

Timeframe: 8 weeks

Change in the systemic inflammatory marker C-reactive protein (CRP)

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)

Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)

Change in systemic inflammatory marker Interleukin 6 (IL-6)

Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)