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Clinical trial

The Effect of Prolotherapy in the Care of Pressure Injuries: A Randomized Controlled Study

ID
Name
22.2022fbu
Description
The goal of this \[type of study: randomized controlled clinical trial\] is to \[Determining the effect of prolotherapy use on the wound care process\]. The main question it aims to answer is: • \[The use of proliferative substances in the care of 1st, 2nd and 3rd stage pressure injuries has a positive effect on the wound healing period\]. Participants will \[in patients with pressure injuries, wound irrigation with saline and wound irrigation with gelofusin were applied\]. Researchers will compare \[depth, length and width of the wound\].
Trial arms
Trial start
2023-06-10
Estimated PCD
2023-06-15
Trial end
2023-06-20
Status
Completed
Phase
Early phase I
Treatment
Gelofusin
In the experimental group, the wound will be washed with gelofusine as prolotherapy, and the wound will be closed with sterile sponge and fixative tape. In the control group, the wound will be covered with sterile sponge and fixative tape by washing with physiological saline.
Arms:
Experimental group
Other names:
there is no other name
Size
20
Primary endpoint
wound healing time
3 days
Eligibility criteria
Inclusion Criteria: * Patients with 1st, 2nd and 3rd stage pressure injuries * Patients over 18 years of age * Patients who volunteered to participate in the study Exclusion Criteria: * Patients without 1st, 2nd and 3rd stage pressure injuries * Patients under 18 years of age * Patients who did not volunteer to participate in the study * Patients allergic to gelofusin solution
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2024-02-26

1 organization

1 product

1 indication

Organization
Fenerbahce University
Product
Gelofusin
Indication
Pressure Ulcer