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The Effect of Prolotherapy in the Care Process of Pressure Injuries

Primary Purpose

Pressure Ulcer

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Gelofusin
Sponsored by
Fenerbahce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pressure Ulcer focused on measuring pressure injury, proliferative, wound care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group

    conroul group

    Arm Description

    The nasopharyngeal suction with positive pressure method was employed in the sample group. In this method, the infant's head is turned to the side, 1-2 ml of PS is injected into the nostril with a syringe, and then positive pressure is exerted with the help of the end of the oxygen hose from the same nostril, with oxygen or air supply at 5-8 lt/min (if the baby requires oxygen, using an oxygen source) and the nasopharyngeal secretions are removed from the nostril into which PS has been not injected. The oxygen hose is held one centimetre away from the infant's nostril. The researchers prepared a guideline for nasopharyngeal suction with positive pressure based on the literature.

    The nasopharyngeal suction with negative pressure method was employed in the control group in this study. In this method, the nasal secretions were softened with 1-2 ml of physiological saline (PS), and then negative pressure suction was performed using a pine-tipped suction set. In the literature, neonatal aspiration pressure is defined as 60-100 mmHg. In this study, the suction pressure was kept between 60 and 80 mmHg, and no suction lasted for more than 15 seconds.

    Outcomes

    Primary Outcome Measures

    wound healing time
    The change in wound healing time will be examined.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 13, 2023
    Last Updated
    May 23, 2023
    Sponsor
    Fenerbahce University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05874284
    Brief Title
    The Effect of Prolotherapy in the Care Process of Pressure Injuries
    Official Title
    The Effect of Prolotherapy in the Care of Pressure Injuries: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 10, 2023 (Anticipated)
    Primary Completion Date
    June 15, 2023 (Anticipated)
    Study Completion Date
    June 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fenerbahce University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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].
    Detailed Description
    In the study, wound irrigation with saline and wound irrigation with gelofusin will be applied to patients with pressure injuries. Cleaning of the wound can be done with gases moistened with saline, or irrigation method can be applied with the help of an injector. Sufficient pressure can be provided with an 18G needle attached injector. Irrigation with 50-100cc saline per square centimeter is recommended. 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. This process will be repeated 2 times a day and will be repeated and observed for 3 days in line with the literature. In this study, while the wound is irrigated, the solution will first be drawn into a 50 cc syringe and prepared. A protective cover will be used to prevent the sterile sponge, fixation tape, gloves and solution required for dressing from contaminating the patient bed. The patient will be given an appropriate position according to the location of the wound. The needle of the syringe containing the solution will be removed and kept at a distance of 3 cm from the wound area, and the solution will be slowly poured over the entire wound. When the irrigation process is finished, the wound area will be dried and the wound will be closed with sterile sponge.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pressure Ulcer
    Keywords
    pressure injury, proliferative, wound care

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    The nasopharyngeal suction with positive pressure method was employed in the sample group. In this method, the infant's head is turned to the side, 1-2 ml of PS is injected into the nostril with a syringe, and then positive pressure is exerted with the help of the end of the oxygen hose from the same nostril, with oxygen or air supply at 5-8 lt/min (if the baby requires oxygen, using an oxygen source) and the nasopharyngeal secretions are removed from the nostril into which PS has been not injected. The oxygen hose is held one centimetre away from the infant's nostril. The researchers prepared a guideline for nasopharyngeal suction with positive pressure based on the literature.
    Arm Title
    conroul group
    Arm Type
    No Intervention
    Arm Description
    The nasopharyngeal suction with negative pressure method was employed in the control group in this study. In this method, the nasal secretions were softened with 1-2 ml of physiological saline (PS), and then negative pressure suction was performed using a pine-tipped suction set. In the literature, neonatal aspiration pressure is defined as 60-100 mmHg. In this study, the suction pressure was kept between 60 and 80 mmHg, and no suction lasted for more than 15 seconds.
    Intervention Type
    Drug
    Intervention Name(s)
    Gelofusin
    Other Intervention Name(s)
    there is no other name
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    wound healing time
    Description
    The change in wound healing time will be examined.
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    rukiye kokkiz
    Phone
    05071406898
    Email
    rky_kokkiz@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    nermin eroglu
    Phone
    05071406898
    Email
    nermim.eroglu@fbu.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Prolotherapy in the Care Process of Pressure Injuries

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