Chlorhexidine gluconate-impregnated cloth in prevention surgical site infection: pilot randomized clinical trial

Andrade, Fernanda de Oliveira; Poveda, Vanessa de Brito

doi:10.37689/acta-ape/2023AO018622

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Acta Paulista de Enfermagem

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Sumário

Original Article • Acta Paul Enferm 36 • 2023 • https://doi.org/10.37689/acta-ape/2023AO018622 copy

Chlorhexidine gluconate-impregnated cloth in prevention surgical site infection: pilot randomized clinical trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Objective

To compare the use of 2% chlorhexidine gluconate-impregnated cloth and 2% liquid chlorhexidine gluconate in the preoperative skin preparation to prevent the occurrence of surgical site infections in patients undergoing clean-contaminated elective surgeries.

Methods

Parallel, single-blind, pilot study of the randomized clinical trial (RCT), composed by forty-eight patients underwent clean-contaminated elective surgeries were randomly assigned to the intervention group (n=25, 2% chlorhexidine gluconate-impregnated cloth) and the control group (n=23, pre-operative bathing with 2% liquid chlorhexidine gluconate). The primary outcome was surgical site infection within 30 days after surgery. The patients were instructed to use the products at the night before and at the morning of surgery and received verbal and written instruction on their use. The tests Wilcoxon-Mann-Whitney, Two Sample t-test, Pearson X² and Fisher’s exact tests, risk relative (RR) and 95% confidence interval (CI) were used. The level of significance for all variables was set at α = 5%.

Results

48 patients analyzed, eight (16.7%) developed a surgical site infection. There were no statistically significant differences between the groups regarding the incidence of surgical site infection (RR: 0.92; 95% CI: 0.25-3.25; p=0.898), however there were not cases of superficial incisional surgical site infection in the intervention group.

Conclusion

The use of 2% chlorhexidine gluconate-impregnated cloth for preoperative skin preparation did not reveal a statistically significant difference in the prevention of surgical site infection compared to the use of pre-operative bathing with 2% liquid chlorhexidine gluconate. Brazilian clinical trial registry: RBR-8httxs Registered at ClinicalTrials.gov: NCT03813693

Chlorhexidine; Surgical wound infection; Preoperative period; Perioperative nursing; Surgical procedures operatives

Variables	Intervention group (n=25)	Control group (n=23)	p-value
Age (years), mean (SD*)	46.7 (9.3)	46.8 (12.2)	0.702^‡
BMI^† (kg/m²), mean (SD*)	36.3 (9.4)	35.5 (9.7)	0.613^‡
Anesthesia duration (minutes), mean (SD*)	201.9 (50.6)	210.9 (54.9)	0.373^‡
Surgery duration (minutes), mean (SD*)	161 (38.1)	171.4 (51.2)	0.371^‡
Professionals in the surgical room, mean (SD*)	4.1 (0.9)	4 (0.9)	0.612^‡
Preoperative hospitalization (days), mean (SD*)	1.0 (0.2)	1.2 (0.8)	0.269^‡
Postoperative hospital stay (days), mean (SD*)	2.7 (1.4)	2.4 (0.9)	0.473^‡

Variables	Intervention group (n=25)		Control Group (n=23)		RR*** (95% CI^¶¶)	p-value
Variables	NSSI* (n=21) n(%)	SSI^† (n=4) n(%)	NSSI* (n=19) n(%)	SSI^† (n=4) n(%)	RR*** (95% CI^¶¶)	0,898**
Age (years), mean (SD^‡)	47.7(9.7)	41.8(5.5)	46.1(11.9)	50.5(14.8)		0.849^††
BMI^§ (Kg/m²), mean (SD^‡)	37(9.5)	32.5(9.3)	34.6(10.3)	39.8(4.4)		0.933^††
Sex
Female	21(100)	4(100)	15(78.9)	2(50)		0.247^‡‡
Male	0(0)	0(0)	4(21)	2(50)		0.247^‡‡
Comorbidities
DM^║	6(28.6)	1(25)	4(21)	3(75)		0.160^‡‡
Cancer	2(9.5)	1(25)	5(26.3)	1(25)		0.614**
Smoking	1(4.8)	0(0)	3(15.7)	0(0)		0.571**
Hair removal	10(47.6)	3(75)	9(47.4)	2(50)		0.482^‡‡
ASA^¶ classification						0.071**
ASA^¶ I	3(14.3)	0(0)	2(10.5)	0(0)
ASA^¶ II	11(52.4)	1(25)	12(63.2)	1(25)
ASA^¶ III	7(33.3)	3(75)	5(26.3)	3(75)
Preoperative hospitalization (days), mean (SD^‡)	1.0(0.2)	1.0(0.0)	1.2 (0.9)	1.2(0.5)		0.448^§§
Postoperative hospital stay (days), mean (SD^‡)	2.4 (0.8)	4.0(2.8)	2.2 (0.9)	3.2(0.9)		0.067^║║
Duration of anesthesia (minutes), mean (SD^‡)	206(51.5)	172(37.5)	199 (51.9)	269(23.9)		0.261^††
Duration of surgery (minutes), mean (SD^‡)	163(38.7)	152(39.3)	161 (48.4)	214(45)		0.227^††
Professionals in the surgical room, mean (SD^‡)	4.2(0.9)	3.5(0.5)	3.8(0.9)	4.7(0.9)		1.000^§§
Surgery						0.687**
Gastrointestinal	11(52.4)	0(0)	9(47.4)	3(75)
Gynecological	8(38.1)	3(75)	9(47.4)	0(0)
Gynecological + gastrointestinal	2(9.5)	1(25)	1(5.2)	0(0)
Urologic	0(0)	0(0)	0(0)	1(25)
Anesthesia						1.000^‡‡
Epidural/spinal + general	14(66.7)	2 (50)	14(73.7)	2(50)
Spinal	5(23.8)	2 (50)	4(21)	0(0)
General	2(9.5)	0(0)	1(5.3)	1(50)
Antibiotic prophylaxis						0.206**
First-generation cephalosporin	21(100)	4(100)	17(89.5)	3(75)
Third-generation cephalosporin	0(0)	0(0)	0(0)	1(25)
None	0(0)	0(0)	2(10.5)	0(0)
Blood transfusion	3(14.3)	0(0)	2(10.5)	1(25)		1.000^‡‡
Drains	3(14.3)	0(0)	1(5.3)	1(25)		1.000**
New surgical intervention	0(0)	1(25)	0(0)	0(0)	2.76(0.11- 64.76)	0.167**
Hospital readmissions	0(0)	1(25)	0(0)	1(25)	0.92(0.06-13.87)	0.025**
Intraoperative complications	2(9.5)	1(25)	0(0)	1(25)		0.191**

Escola Paulista de Enfermagem, Universidade Federal de São Paulo R. Napoleão de Barros, 754, 04024-002 São Paulo - SP/Brasil, Tel./Fax: (55 11) 5576 4430 - São Paulo - SP - Brazil
E-mail: actapaulista@unifesp.br

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[1] Autor correspondente: Fernanda de Oliveira Andrade E-mail: feroa1@hotmail.com