NCT05983302

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

Repairing Gel (Supraz) and Platelet-rich Plasma-Fibrin Glue (PRP-FG) in Eliminating Odor and Healing the Malodorous Chronic Wounds Versus Standard of Care

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mashhad University of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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%).

Conditions

• Wounds and Injuries

Interventions

Type	Name	Description
DRUG	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.
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.
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.
OTHER	Classical wound irrigation (control)	For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.

Timeline

• Start date: 2023-08-20
• Primary completion: 2024-01-20
• Completion: 2024-03-20
• First posted: 2023-08-09
• Last updated: 2024-03-26

Locations

2 sites across 2 countries: Greece, Iran