To compare the therapeutic efficacy of cryopreserved amniotic membrane (AM) grafts and standard of care (SOC) in treating nonhealing wounds (NHW) through a prospective multicenter clinical trial, 42 patients (76% polymorbid) with 54 nonhealing wounds of various etiologies (mainly venous) and an average baseline size of 20 cm2 were included. All patients were treated for at least 6 weeks in the center before they were involved in the study. In the SOC group, 29 patients (36 wounds) were treated. If the wound healed less than 20% of the baseline size after 6 weeks, the patient was transferred to the AM group (35 patients, 43 wounds). Weekly visits included an assessment of the patient's condition, photo documentation, wound debridement, and dressing. Quality of life and the pain degree were subjectively reported by patients. After SOC, 7 wounds were healed completely, 1 defect partially, and 28 defects remained unhealed. AM application led to the complete closure of 24 wounds, partial healing occurred in 10, and 9 remained unhealed. The degree of pain and the quality of life improved significantly in all patients after AM application. This study demonstrates the effectiveness of cryopreserved AM grafts in the healing of NHW of polymorbid patients and associated pain reduction.
- Publikační typ
- časopisecké články MeSH
Cíl: Představit použití lidské kryokonzervované amniové membrány (AM) v léčbě chronických ran, specifikovat indikační kritéria pro její aplikaci, protokol aplikace a metodiku převazů. Dalším cílem je seznámení se souhrnnými výsledky studie léčby chronických nehojících se ran pomocí AM a s predikcí zhojení dle dynamiky léčby. Materiály a metody: Standardizace léčby pomocí kryokonzervované AM proběhla v rámci multicentrické studie ve třech klinických centrech. Pacientům s chronickými ranami, kteří se nehojili v průměru po dobu 34 měsíců (minimálně šest týdnů), byla aplikována AM, s pravidelnými vizitami po sedmi dnech. Výsledky: Z 35 pacientů s 43 ranami různé etiologie, bylo po aplikaci AM zcela zhojeno 24 ran (56 %), 10 ran bylo zhojeno částečně (> 50 % plochy rány) (23 %), 9 ran (21 %) se zhojit nepodařilo. Během léčby AM zaznamenali pacienti silný analgetický účinek. Sledování dynamiky hojení vedlo ke stanovení predikčního intervalu pro posouzení schopnosti rány zhojit se pomocí AM na 10–12 týdnů. Závěr: Léčba chronických ran pomocí AM přináší prospěch indikovaným pacientům, jak v akceleraci hojení, tak ve zlepšení kvality života, a to zejména snížení bolesti v oblasti rány.
Objective: This work presents the use of human cryopreserved amniotic membrane (AM) in the treatment of chronic wounds, specifying the indication criteria for its application, application protocol, and wound dressing methodology. At the same time, it presents the summary results of the study of the treatment of chronic non-healing wounds using AM with the prediction of healing according to the dynamics of the treatment. Materials and methods: Standardization of treatment using cryopreserved AM took place within the framework of a multicentre study in three specialist centres. Patients with chronic wounds that did not heal for an average of 34 months (min. six weeks) were treated with AM, with regular visits every seven days. The AM application was carried out 1–2 times in 14 days. Results: Out of 35 patients with 43 wounds of various etiologies, 24 wounds (56%) were completely healed after AM application, 10 wounds were partially healed (> 50% of the wound area) (23%), 9 wounds (21%) failed to heal. During AM treatment, patients experienced a strong analgesic effect. Monitoring the dynamics of healing led to the establishment of a prediction interval for assessing the ability of the wound to heal using AM at 10–12 weeks. Conclusion: The treatment of chronic wounds using AM brings benefits to the indicated patients, both in the acceleration of healing and in the improvement of the quality of life, especially in the reduction of pain in the wound area.
- MeSH
- amnion * fyziologie MeSH
- biologické krytí * klasifikace MeSH
- hojení ran MeSH
- kryoprezervace metody MeSH
- lidé MeSH
- membrány fyziologie MeSH
- placenta fyziologie MeSH
- rány a poranění ošetřování terapie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- multicentrická studie MeSH
- práce podpořená grantem MeSH