The Effect of Prolotherapy in the Care Process of Pressure Injuries

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05874284
• Other study ID #: 22.2022fbu
• Status: Completed
• Phase: Early Phase 1
• Start date: June 10, 2023
• Est. completion date: June 20, 2023

Study information

• Verified date: February 2024
• Source: Fenerbahce University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 20, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Ulcer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Fenerbahce University	I?stanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Fenerbahce University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing time	The change in wound healing time will be examined.	3 days