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. 2020 Nov 6;99(45):e23079.
doi: 10.1097/MD.0000000000023079.

The efficacy of gelatin sponge combined with moist wound-healing nursing intervention for the treatment of pressure ulcers: A randomized controlled trial protocol

Shun Huang  1 , Ying Yang  1 , Xiaoli Yu  2 , Yonggang Wang  3
Affiliations

The efficacy of gelatin sponge combined with moist wound-healing nursing intervention for the treatment of pressure ulcers: A randomized controlled trial protocol

Shun Huang et al. Medicine (Baltimore). .

Expression of concern in

  • Expression of Concern: Study Protocols.
    [No authors listed] [No authors listed] Medicine (Baltimore). 2025 Nov 7;104(45):e46330. doi: 10.1097/MD.0000000000046330. Medicine (Baltimore). 2025. PMID: 41204616 Free PMC article. No abstract available.

Abstract

Objective: The objective of this current research is to investigate the effectiveness of the nursing intervention of combination gelatin sponge and moist wound healing in treating the pressure ulcers (PUs).

Methods: This is a randomized controlled trial to be carried out from January 2021 to May 2021. This trial is implemented in accordance with the SPIRIT Checklist for the randomized researches and was granted through the Ethics Committee of 5th Medical Center of Chinese PLA General Hospital (No. 0624876). This study includes 80 PU participants. The patients meet the following criteria will be included. All participants meet the diagnostic criteria recommended via the National Pressure Ulcer Advisory Panel Society: complete skin defect, no bones, tendons and muscles exposure, no subcutaneous tunnel or scale; the patients selected are between 40 and 60 years old. The patients with the following criteria will be excluded: receiving other treatments that may influence the healing, for instance, radiation therapy and corticosteroids; patients with the complications of infection, malignant tumors, as well as peripheral vascular disease; and patients with serious diseases, containing kidney, cardiac, and liver diseases. The patients are randomly divided into 2 groups, the control group and study group, with 40 members in each group. In control group, the patients are given the routine nursing care. And in study group, the patients are given the nursing of gelatin sponge combined with moist wound-healing. After 28 days, the state of the patients healing is observed closely, containing the dressing change frequency, curative effects, and the end-point efficiency. On the basis of the Pressure Ulcer Healing Scale developed by the American pressure sore expert group, the quantitative scoring can be implemented, and therapeutic effects are assessed.

Results: The variables of clinical result among the groups are illustrated in the Table.

Conclusion: The nursing intervention of gelatin sponge combined with the moist wound- healing may evidently increase the healing efficiency of PU.

Trial registration number: researchregistry 6091.

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Conflict of interest statement

The authors report no conflicts of interest.

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