Clinical trial NCT05874284: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pressure Ulcer
Keywords: pressure injury
proliferative
wound care
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: wound healing time
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Fenerbahce University
state: Atasehir
Study officials:
References: