Pressure ulcer healing with Plenusdermax<sup>®</sup> <i>Calendula officinalis</i> L. extract

an observational cohort study, including 41 patients with a diagnosis of pressure ulcer that was stable in size for more than three months. Patients were evaluated every two weeks, over 30 weeks, for: reduction of the wound area, infection control, types of tissue and exudate, and ulcer microbiology.

Results:

the proportions of patients who were completely healed after 15 and 30 weeks of treatment were 63% and 88%, respectively, and the mean healing time was 12.5±7.8 weeks. No adverse events were observed during treatment.

Conclusion:

the results of the study indicate that bioactive C. officinalis Plenusdermax^® is a safe treatment that promotes healing of pressure ulcers.

Key words:
Pressure Ulcer; Wound Healing; Inflammation; Anti-inflammatory; Calendula Officinalis

Inclusion criteria	Exclusion criteria
• Age between 18 and 90 years.	• Stage IV pressure ulcers or necrotic tissue that could not be adequately debrided by the nursing team.
• No previous history of allergy to any plant of the Asteraceae family	• Pressure ulcers with clinical evidence of apparent infec-tion, e.g., ulcers surrounded by an advanced, hard red edge, hot or tender with very purulent exudate.
• Pressure ulcer (target ulcer) determined by clinical as-sessment, present for at least five weeks from the date of the screening visit, with a surface area between 1-30 cm2 measured by computerized planimetry, in the sacral or trochanteric region, classified as stage II to III, according to NPUAP PUSH scale.	• Individuals with an infected target ulcer, including (but not limited to) cellulitis, osteomyelitis, or gangrene, infections of deeper tissues.
• Non-diabetic patients (type 1 or type 2), as diagnosed by a physician, with adequate glycemic control during selection. Blood glucose, glycosylated hemoglobin A1c, serum albumin, blood count, erythrocyte sedimen-tation rate, bacterioscopy, swab culture and antibiogram of the wound bed, measured at the screening visit, to help the researcher in selection.	• Clinically significant medical conditions that can impair wound healing (e.g., kidney, liver, anemia, severe malnutrition and immunocompromising).
• Willingness to be visited by the nursing team during the study period.	• Pregnant women of childbearing age who do not use an approved method of contraception.
• Individuals or caregivers who can follow strict protocol recommendations required during the study period.	• Individuals who are receiving or have received corticosteroids, immunosuppressants, radiation or chemotherapy systemically (oral/intravenous) within four weeks of entering the study.
	• History of Plenusdermax^® use in the target ulcer less than 12 weeks before the screening visit.
	• History of drug or alcohol abuse in the previous year, or those who currently use illicit drugs.
	• Individuals with any other condition which, in the opinion of the investigator, would render the patient ineligible for the study.

	Characteristics	At the beginning	After 30 weeks
Parameters
Gender
	Male n (%)		27 (66%)
	Female n (%)		14 (34%)
	Age		53 ± 12.3
Blood tests
	Blood glucose (mg/dL)		95.3 ± 18.2
	Serum albumin (g/dL)		4.04 ± 0.74
	Hemoglobin (g/dL)		13.2 ± 1.58
	Pain score (1–10)		0.8 ± 1.95^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	PUSH Score		2.24 ± 4.21^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
Ulcer parameters:
Classification n (%)
	Stage II		2 (4.9%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Stage III		3 (7.3%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
Location: n (%)
	Buttocks	18 (42.8%)	6 (14.3%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Sacrum	9 (21.4%)	2 (4.8%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Trochanter	6 (14.3%)	1 (7.2%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Heel	3 (7.2%)	0 (0.0%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Back	2 (4.8%)	0 (0.0%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Thigh	2 (4.8%)	0 (0.0%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Leg	1 (2.4%)	0 (0.0%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Toes	1 (2.4%)	0 (0.0%)^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Duration (weeks)	41.4 ± 36.6	-
	Ulcer baseline area (cm2)	3.74 ± 2.34	0.54 ± 1.66^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
Aspect of the wound bed
	% Epithelium	5.1%	87.8%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	% Granulation	68.4%	21.3%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	% Moderate exudate	78.1%	12.2%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	% Fibrin	26.8%	7.3%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	% Necrosis	12.2%	0.0%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	% Unpleasant odor	36.6%	2.4%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
Ulcer microbiology
	Staphylococcus aureus	14.8%	0.0%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Pseudomonas aeruginosa	7.3 %	2.4%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Klebsiella pneumoniae	4.9 %	0.0%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Escherichia coli	14.8%	4.8%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.
	Others	12.2%	2.4%^(a) (a) Significant difference (Mann-Whitney’s U Non-parametric Test, p <0.05); Values are mean ± standard deviation, unless otherwise stated.

Groups according to ulcer size (cm²)	All	Smaller 1.0 – 3.9	Bigger 4.0 – 10.0	p value^* * Mann Whitney’s Non-parametric U Test, p < 0.05; Values are mean±standard deviation, unless otherwise stated.
Number of patients	41	29	12
Duration (weeks)	41.4 ± 33.6	42.3 ± 36.2	39.3 ± 22.6	0.850
Initial area (cm²)	3.74 ± 2.82	2.23 ± 0.81	7.71 ± 2.65	≤ 0.001
Final area (cm²)	0.55 ± 1.66	0.00 ± 0.00	2.03 ± 2.65	≤ 0.001
Mean time until healing (weeks)	12.0 ± 7.85	11.7 ± 7.64	12.9 ± 9.45	0.857
% healing (30 weeks)	87.8	100.0	58.3
Wound contraction index per week (WoC - mm²/week)	36.1 ± 32.6	30.2 ± 24.3	45.8 ± 41.8	0.465
Percentage wound rate (WHR%)	12.4 ± 11.1	14.3 ± 11.7	6.6 ± 5.3	0.027

Associação Brasileira de Enfermagem SGA Norte Quadra 603 Conj. "B" - Av. L2 Norte 70830-102 Brasília, DF, Brasil, Tel.: (55 61) 3226-0653, Fax: (55 61) 3225-4473 - Brasília - DF - Brazil
E-mail: reben@abennacional.org.br

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[1] CORRESPONDING AUTHOR: Marcelo Buzzi. E-mail: marcelo.buzzi@gmail.com

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Pressure ulcer healing with Plenusdermax® Calendula officinalis L. extract

ABSTRACT

Objective:

Method:

Results:

Conclusion:

Pressure ulcer healing with Plenusdermax^® Calendula officinalis L. extract