The Effect of Hair Removal on Intraoperative Contamination

Intraoperative Complications Clinical Trial

Official title:

The Effect of Hair Removal on Intraoperative Contamination

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04256928
• Other study ID #: 70136
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: February 2020
• Source: Herlev and Gentofte Hospital
• Contact: Ditte Harder, Student
• Phone: +4538673364
• Email: ditte.marie.bak.harder[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, non-blinded, randomized controlled trial with the purpose of investigating, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination.

The primary investigators hypothesis is this: Preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination.

200 male participants, 18 years or older, with a planned primary knee replacement surgery, will be enrolled.

During surgery, four microbiological samples will be taken from each participant.

The primary outcome is whether there is intraoperative contamination of the surgical site or not, determined by identification of any grown bacteria from the samples.

If this study finds, that the contamination rate is lowered by preoperative electrical clipping of body hair, it will provide a cost-effective method of reducing the risk of intraoperative contamination and consequent postoperative infection, a solid argument for a change of current guidelines for preoperative hair removal, and provide additional information pointing towards body hair as a possible explanation for the increased infection rate in men.

Description:

A late ph.d.-study conducted at Herlev and Gentofte Hospital has shown a 15 percentage difference in contamination rates when comparing participants who had their body hair removed preoperatively, and those who did not.

Based on the finds in the aforementioned study, the hypothesis for this study is that preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination.

The purpose of this study is to investigate, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination.

A prospective, non-blinded, randomized controlled trial will be performed. The study population consists of 200 male patients, 18 years or older, with a planned primary knee replacement surgery. The study population consists of only male patients, since males generally have denser body hair and a higher contamination rate than females. Exclusion criteria include known skin disease, use of antibiotics 4 weeks prior to surgery, if patients due to mental reasons, a language barrier or other reasons are unable to participate in the study, as well as no body hair in the surgical field.

Participants will be randomized to either the intervention group (preoperative electrical clipping) or the control group (leaving the body hair intact) using a 1:1 randomization ratio. The randomization is performed electronically by a medical student or the operating surgeon and the pre-assessment consultation.

Clipping is performed by hospital staff on the day of surgery. The degree of body hair on both knees is photo-documented for all participants, for the intervention group after the clipping of body hair on the relevant knee has been performed.

During the surgery, biological material from every participant is collected as four microbiological samples, taken using Copan ESwabs. The first swab is taken before the skin is surgically prepared, the second immediately after incision of the skin, the third swab is taken just prior to the change of gloves performed before cementation of the prothesis, and the last swab is taken after closure of the joint capsule before closure of the skin. Samples will be collected at Orthopedic Departments of Gentofte Hospital. All samples will be sent to Department of Clinical Microbiology, Herlev Hospital, for culturing.The bacteria will be identified following Danish guidelines.

The material consists of culture results from all samples. The primary outcome is whether there is intraoperative contamination of the surgical site or not. This is determined by identification of any grown bacteria.The material will be statistically analyzed using the program R Studio. Since data is categorial, a chi-squared test will be performed to evaluate the significance of the possible difference of contamination rate in the two participant groups.

All possibilities for conducting the study are known to exist, as the method described above has previously been used in the PhD study conducted at the department: "Intraoperative microbial contamination, its prevention and its consequences for outcomes following knee replacement surgery- The ICON study".

Personal data is processed as part of the project. All handling and processing of personal data follows the Data Protection Regulation and the Data Protection Act.

Data collected during the pre-assessment consultation will be entered directly into a database. Only data in this database will be available to the investigators conducting the study, for further analysis. Information about the microbiological samples and cultures will be entered into the database as well. All information in the database will be anonymized 2 years after collection of data is complete.

By consenting to participating in this study, participants also consent to the investigators conducting the study, Herlev-Gentofte Hospital and their representatives to be given direct access to the collected data. Consenting to participate also involves consenting that the Regional Committee on Health Research Ethics are allowed direct access to all data collected, to facilitate their control with the project.

If this study finds, that the contamination rate is lowered by preoperative electrical clipping of body hair, it will not only provide a cost-effective method to reduce the risk of intraoperative contamination and consequent postoperative infection, but may also lead to a change of current guidelines to preoperative electrical clipping of body hair becoming a permanent practice. In addition, the study will confirm existing finds pointing towards body hair as a possible explanation for the increased infection rate in men.

A decrease in the incidence of infections will save patients from unpleasant and often prolonged consequences of infection, including pain, revisions, antibiotic treatments and, at worst, loss of mobility. In addition, fewer infections will lead to savings in the health care system, with the release of funds and beds, to the benefit of patients in general and the social economy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned primary knee replacement surgery

Exclusion Criteria:

• Known skin disease

• Use of antibiotics 4 weeks prior to surgery

• If patients due to mental reasons, a language barrier or other reasons are unable to participate in the study

• No body hair in the surgical field

Related Conditions & MeSH terms

• Intraoperative Complications

Intervention

Procedure:
• Preoperative electrical clipping
Body hair in the operative field will be clipped with an electrical clipper by hospital personnel during preparation to planned surgery.

Locations

Country	Name	City	State
Denmark	Ortopædkirurgisk Afdeling T, Herlev og Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (20)

Aboltins C, Daffy J, Choong P, Stanley P. Current concepts in the management of prosthetic joint infection. Intern Med J. 2014 Sep;44(9):834-40. doi: 10.1111/imj.12510. Review. — View Citation

Al-Maiyah M, Hill D, Bajwa A, Slater S, Patil P, Port A, Gregg PJ. Bacterial contaminants and antibiotic prophylaxis in total hip arthroplasty. J Bone Joint Surg Br. 2005 Sep;87(9):1256-8. — View Citation

Arnold WV, Shirtliff ME, Stoodley P. Bacterial biofilms and periprosthetic infections. Instr Course Lect. 2014;63:385-91. — View Citation

Broekman ML, van Beijnum J, Peul WC, Regli L. Neurosurgery and shaving: what's the evidence? J Neurosurg. 2011 Oct;115(4):670-8. doi: 10.3171/2011.5.JNS102003. Epub 2011 Jul 1. Review. — View Citation

Byrne AM, Morris S, McCarthy T, Quinlan W, O'byrne JM. Outcome following deep wound contamination in cemented arthroplasty. Int Orthop. 2007 Feb;31(1):27-31. Epub 2006 Apr 4. — View Citation

Falk-Brynhildsen K, Friberg O, Söderquist B, Nilsson UG. Bacterial colonization of the skin following aseptic preoperative preparation and impact of the use of plastic adhesive drapes. Biol Res Nurs. 2013 Apr;15(2):242-8. doi: 10.1177/1099800411430381. Epub 2012 Jan 24. — View Citation

Gallo J, Kolár M, Novotný R, Riháková P, Tichá V. Pathogenesis of prosthesis-related infection. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2003 Nov;147(1):27-35. Review. — View Citation

Grice EA, Kong HH, Renaud G, Young AC; NISC Comparative Sequencing Program, Bouffard GG, Blakesley RW, Wolfsberg TG, Turner ML, Segre JA. A diversity profile of the human skin microbiota. Genome Res. 2008 Jul;18(7):1043-50. doi: 10.1101/gr.075549.107. Epub 2008 May 23. — View Citation

Hesselvig AB, Bjarnsholt T, Arpi M, Madsen F, Odgaard A, group ObotIs. The use of iodine impregnated incision drape in knee arthroplasty surgery - a prospective, randomized trial.

Jonsson EÖ, Johannesdottir H, Robertsson O, Mogensen B. Bacterial contamination of the wound during primary total hip and knee replacement. Median 13 years of follow-up of 90 replacements. Acta Orthop. 2014 Apr;85(2):159-64. doi: 10.3109/17453674.2014.899848. — View Citation

Jose B, Dignon A. Is there a relationship between preoperative shaving (hair removal) and surgical site infection? J Perioper Pract. 2013 Jan-Feb;23(1-2):22-5. Review. — View Citation

Kjønniksen I, Andersen BM, Søndenaa VG, Segadal L. Preoperative hair removal--a systematic literature review. AORN J. 2002 May;75(5):928-38, 940. Review. — View Citation

Lange-Asschenfeldt B, Marenbach D, Lang C, Patzelt A, Ulrich M, Maltusch A, Terhorst D, Stockfleth E, Sterry W, Lademann J. Distribution of bacteria in the epidermal layers and hair follicles of the human skin. Skin Pharmacol Physiol. 2011;24(6):305-11. doi: 10.1159/000328728. Epub 2011 Jul 15. — View Citation

Lefebvre A, Saliou P, Lucet JC, Mimoz O, Keita-Perse O, Grandbastien B, Bruyère F, Boisrenoult P, Lepelletier D, Aho-Glélé LS; French Study Group for the Preoperative Prevention of Surgical Site Infections. Preoperative hair removal and surgical site infections: network meta-analysis of randomized controlled trials. J Hosp Infect. 2015 Oct;91(2):100-8. doi: 10.1016/j.jhin.2015.06.020. Epub 2015 Aug 4. Review. — View Citation

Pan A, Ambrosini L, Patroni A, Soavi L, Signorini L, Carosi G, Santini C; Gruppo Italiano di Studio sulle Infezioni in Cardiochirurgia Study Group. Adherence to surgical site infection guidelines in Italian cardiac surgery units. Infection. 2009 Apr;37(2):148-52. doi: 10.1007/s15010-008-7474-8. Epub 2009 Mar 23. — View Citation

Shi D, Yao Y, Yu W. Comparison of preoperative hair removal methods for the reduction of surgical site infections: a meta-analysis. J Clin Nurs. 2017 Oct;26(19-20):2907-2914. doi: 10.1111/jocn.13661. Epub 2017 Mar 12. Review. — View Citation

Tanner J, Woodings D, Moncaster K. Preoperative hair removal to reduce surgical site infection. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004122. Review. Update in: Cochrane Database Syst Rev. 2011;(11):CD004122. — View Citation

Trampuz A, Zimmerli W. Prosthetic joint infections: update in diagnosis and treatment. Swiss Med Wkly. 2005 Apr 30;135(17-18):243-51. Review. — View Citation

Webster J, Alghamdi A. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database Syst Rev. 2015 Apr 22;(4):CD006353. doi: 10.1002/14651858.CD006353.pub4. Review. — View Citation

Wilson VanVoorhis CR, Morgan BL. Understanding Power and Rules of Thumb for Determining Sample Sizes. Tutorials in Quantitative Methods for Psychology. 2007;3:43-50.

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative contamination rate	Rate of contamination as amount of indentified bacteria cultured.	1 year