Within‐patient randomised clinical trial exploring the development of microskin implantation in the treatment of pressure ulcers

Zhang, Ming; Sun, Jiachen; Zhu, Minhui; Sun, Tianjun; Shi, Zhiyuan; Zhang, Lu; Wang, Xingtong; Song, Yaoyao; Ye, Xiangbo; Deng, Yuanxin; Chu, Wanli; Shen, Chuanan

doi:10.1111/iwj.14051

Cited by 3 publications

(1 citation statement)

References 32 publications

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“… 29 , 30 This approach is not directly applicable to the study of VLU, as it is rare to find a perfectly matching contralateral ulcer for comparison. One study in pressure ulcers 31 used a separate part of the same pressure ulcer as a control, but this relies on some assumptions about the homogeneity of the ulcer, and the spatial uniformity of conditions including applied pressure.…”

Section: Discussionmentioning

confidence: 99%

A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions

Bull

Clements

Collarte

et al. 2023

Advances in Wound Care

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Background: Randomized controlled trials using complete healing as an endpoint suffer from poor statistical power, owing to the heterogeneity of wounds and their healing trajectories. The Food and Drug Administration (FDA) has recently consulted with expert groups to consider percentage area reduction (PAR) of the wound over a 4-week period as a valid intermediate endpoint, creating the opportunity for more powerful study designs. Methods: A within-subject controlled study design comparing the PAR of venous leg ulcers (VLU) in patients over 4 weeks receiving different interventions. Twenty-nine patients received multilayer compression over 4 weeks, followed by neuromuscular electrostimulation (NMES) of the leg muscle pump in addition to compression for a further 4 weeks. Paired comparison was then made of PAR between the two phases. A second cohort of 22 patients received only multilayer compression throughout both 4-week phases. Results: Patients randomized to NMES saw a significant increase in healing rate compared with compression alone, whereas patients receiving compression only saw no significant change in healing rate throughout the course of the study. Conclusions: Intermittent NMES of the common peroneal nerve significantly accelerates the healing of VLU. It is well tolerated by patients and deserves serious consideration as an adjuvant to compression therapy. PAR is a useful metric for comparing the performance of wound healing interventions, and the self-controlled trial design allows sensitive discrimination with a relatively small number of subjects over a reasonably short trial period. The study is reported according to the CONSORT reporting guidelines. Clinical Trial Registration: NCT03396731 (ClinicalTrials.gov).

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Section: Discussionmentioning

confidence: 99%

A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions

Bull

Clements

Collarte

et al. 2023

Advances in Wound Care

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Within‐patient randomised clinical trial exploring the development of microskin implantation in the treatment of pressure ulcers

Zhang

Sun

Zhu

et al. 2022

International Wound Journal

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Pressure injury often seriously affects the life quality of aged patients, especially the long-term bedridden casualties. Widely adopted by different disciplines, negative pressure suction has its role in pressure injury. Microskin implantation has been demonstrated powerful in increasing the expansion ratio of donor area-derived skin and accelerating wound healing by forming "skin islands". The study was designed to evaluate the efficacy and safety of additional use of bedside microskin implantation in the palliative care of pressure injury of aged patients who cannot tolerate surgical treatment as a supplement for standard negative pressure suction. An open-label within-patient RCT was conducted in aged patients with pressure injury. Sixteen patients were enrolled. After granulation tissues formed, half of a pressure injury was randomised to receive the negative pressure suction as the control group, and the other half exposed to additional bedside microskin implantation as the experimental group. Efficacy was evaluated within 1 month after treatment, and the primary endpoints included the wound healing rate and pressure ulcer scale for healing (PUSH) scores. The secondary outcomes included survival rate of implanted microskin, pain intensity assessment, satisfaction surveys from patients or their family, and pressure ulcer healing complications. Sixteen patients completed the study. After 14 days of operation, 5.63 ± 1.78 out of 10 pieces of implanted microskin survived and formed neonatal epithelium.The wound healing rates of the control group and the experimental group at 1 month were (26.17 ± 9.03%) and (35.95 ± 16.02%), respectively (P < .01). The mean PUSH score before the surgery was 12.38 ± 2.23. At 1 month after Ming Zhang, Jiachen Sun, and Minhui Zhu contributed equally to the manuscript.

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Repair of pressure ulcers in the elderly using autologous microskin implantation and negative pressure wound therapy: A retrospective study

Su,

Xiong,

Zeng

et al. 2024

THC

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BACKGROUND: Pressure ulcers remain a worldwide problem. OBJECTIVE: To introduce an intermittent and feasible wound treatment method for the treatment of pressure ulcers in elderly patients. METHODS: This surgical procedure was performed on eight elderly patients suffering from pressure ulcers. Microskin measuring 0.1 × 0.1 centimeters was cut from a small amount of thin skin and then grafted onto the wound surface in conjunction with closed negative pressure therapy. RESULTS: Seven patients had their wounds closed after a single surgery, while one patient required two surgeries to close the wound. CONCLUSION: Autologous microskin implantation for the treatment of pressure ulcers in the elderly is an effective method to close the wound, which can prevent the elderly from living with wounds in their later years and is a viable treatment option.

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Within‐patient randomised clinical trial exploring the development of microskin implantation in the treatment of pressure ulcers

Cited by 3 publications

References 32 publications

A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions

A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions

Within‐patient randomised clinical trial exploring the development of microskin implantation in the treatment of pressure ulcers

Repair of pressure ulcers in the elderly using autologous microskin implantation and negative pressure wound therapy: A retrospective study

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