- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07677761
Manual Lymphatic Drainage on Pressure Injuries
25. juni 2026 opdateret af: Rukiye Kokkiz
The Effect of Manual Lymphatic Drainage on Pressure Injuries: A Pilot Study Example
Pressure injuries are a significant health problem, often resulting from pressure, friction, and impaired tissue perfusion, and are particularly common in individuals in intensive care, those with immobility, and those with chronic diseases.
The literature extensively addresses interventions such as pressure reduction, the use of appropriate support surfaces, wound care practices, and nutritional support in the prevention and treatment of pressure injuries.
However, the role of manual therapies aimed at improving circulation and lymphatic flow, such as manual lymphatic drainage (MLD), in pressure injuries has been examined in a limited number of studies.
This research aims to fill a significant gap in the literature by evaluating the potential effects of manual lymphatic drainage on reducing edema, improving tissue perfusion, and supporting the wound healing process in individuals with pressure injuries.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: rukiye kökkız, LECTURER
- Telefonnummer: +90 507 140 68 98
- E-mail: rky_kokkiz@hotmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Presence of pressure injury in the sacrum region
- Volunteer to participate in the study
- Being over 18 years of age
- Being hospitalized in the anesthesia intensive care unit
Exclusion Criteria:
- Chronic illness that may affect pressure injury healing (malnutrition, hypertension, and diabetes)
- Discharge during the investigation process
- Death during the investigation process
- Acute cellulitis
- Severe heart failure
- Renal failure
- Tuberculosis
- Superior vena cava obstruction
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Manual lymphatic drainage group
Individuals will be randomly assigned to intervention and control groups in a 1:1 ratio via the website random.org.
The Bates-Jensen Wound Assessment Tool will be administered to all individuals by the researchers.
The size of the wound (length*depth*width) will be measured and recorded.
Standard care will be applied to the control group.
The experimental group will receive standard care along with manual lymphatic drainage according to the protocol below.
Afterwards, the Bates-Jensen Wound Assessment Tool will be administered to all individuals by the researchers, and the size of the wound (length*depth*width) will be measured and recorded.
|
Individuals will be randomly assigned to intervention and control groups in a 1:1 ratio via the website random.org.
The Bates-Jensen Wound Assessment Tool will be administered to all individuals by the researchers.
The size of the wound (length*depth*width) will be measured and recorded.
Standard care will be applied to the control group.
The experimental group will receive standard care along with manual lymphatic drainage according to the protocol below.
Afterwards, the Bates-Jensen Wound Assessment Tool will be administered to all individuals by the researchers, and the size of the wound (length*depth*width) will be measured and recorded.
|
|
Aktiv komparator: comparison group
|
Standard care practices will include regular position changes for patients, use of supportive surfaces to reduce pressure, maintenance of skin integrity, and keeping the wound area clean.
Wound cleaning will be performed with sterile solutions, appropriate debridement methods will be applied in the presence of necrotic tissue, and suitable dressing materials will be selected according to the condition of the wound bed.
In addition, patients' nutritional status, hydration level, and signs of infection will be regularly assessed, and necessary supportive treatments will be provided.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Effect of manual lymphatic drainage
Tidsramme: 3 months
|
The primary aim of this study is to evaluate the effect of manual lymphatic drainage on the healing level of pressure injuries.
Wound healing will be assessed considering the wound stage (Stage 1-2-3-4, unstageable stage, and deep tissue injury) and size (length*width*depth).
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. august 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
19. juni 2026
Først indsendt, der opfyldte QC-kriterier
25. juni 2026
Først opslået (Faktiske)
1. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pressure Injury - MLD
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Experimental
-
Otolith LabsMCRAAfsluttetBPPV | Svimmelhed | Godartet Paroxysmal Positionel Vertigo | Vestibulær migræne | Vestibulær lidelse | Menieres sygdom | Ménières Vertigo | Labrynthitis | Migræne Associated Vertigo | Ukompenseret ensidig vestibulopatiForenede Stater
-
Çankırı Karatekin UniversityAfsluttetHjertefejl | Nyresvigt | Gastro esophageal refluks | Copd | Intensiv afdelings syndromKalkun
-
Hacettepe UniversityAfsluttetEffekten af Humeral Head Depressor Muscle Co-Activation Training i form af funktionelle resultaterKirurgi | Rotator Cuff RiverKalkun
-
University of TorontoCanadian Institutes of Health Research (CIHR)RekrutteringStillesiddende adfærd | Metabolisk forstyrrelseCanada
-
University of ParmaAfsluttetMotorisk aktivitet | Hemiplegisk cerebral pareseItalien
-
University of BurgundyAfsluttet
-
Riphah International UniversityAfsluttet
-
University Hospital, CaenAssociation Francaise de ChirurgieIkke rekrutterer endnuDivertikulær sygdom i venstre side af tyktarmen
-
Reistone Biopharma Company LimitedAfsluttet