The Effect of Prolotherapy in the Care Process of Pressure Injuries

NCT05874284 | Completed Early Phase 1 DMC

• 1 other identifier: 22.2022fbu
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 \[depth, length and width of the wound\].

Conditions

Pressure Ulcer

Keywords

pressure injury; proliferative; wound care

Outcome Measures

Primary Outcomes (1)

• wound healing time

  The change in wound healing time will be examined.

  3 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Drug: Gelofusin

conroul group

NO INTERVENTION

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.

Interventions

Gelofusin DRUG

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.

Also known as: there is no other name

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 1st, 2nd and 3rd stage pressure injuries
• Patients over 18 years of age
• Patients who volunteered to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahce University

Istanbul, Atasehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

succinylated gelatin

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: May 24, 2023
• Study Start: June 10, 2023
• Primary Completion: June 15, 2023
• Study Completion: June 20, 2023
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)