The Effect of Hair Removal on Intraoperative Contamination

NCT04256928 | Unknown

• 1 other identifier: 70136
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraoperative Complications

Outcome Measures

Primary Outcomes (1)

• Intraoperative contamination rate

  Rate of contamination as amount of indentified bacteria cultured.

  1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

This group of participants will have any body hair in the operative field clipped with an electrical clipper by hospital personnel, during preparation for planned surgery. 4 microbiological samples will be taken from all participants in this group.

Procedure: Preoperative electrical clipping

Control group

NO INTERVENTION

This group of participants serve as the control group. Any body hair in the operative field is left intact. 4 microbiological samples will be taken from all participants in this group.

Interventions

Preoperative electrical clipping PROCEDURE

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study population consists of only males, since males generally have denser body hair and a higher contamination rate than females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned primary knee replacement surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Ortopædkirurgisk Afdeling T, Herlev og Gentofte Hospital

Hellerup, 2900, Denmark

Location

Related Publications (20)

• 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.

  BACKGROUND

• Gallo J, Kolar M, Novotny R, Rihakova P, Ticha V. Pathogenesis of prosthesis-related infection. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2003 Nov;147(1):27-35. doi: 10.5507/bp.2003.004.

  PMID: 15034602 BACKGROUND

• 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. doi: 10.1007/s00264-006-0121-z. Epub 2006 Apr 4.

  PMID: 16586132 BACKGROUND

• Jonsson EO, 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.

  PMID: 24650025 BACKGROUND

• 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. doi: 10.1302/0301-620X.87B9.15685.

  PMID: 16129753 BACKGROUND

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

  PMID: 25901509 BACKGROUND

• Falk-Brynhildsen K, Friberg O, Soderquist 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.

  PMID: 22278031 BACKGROUND

• 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.

  PMID: 18502944 BACKGROUND

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

  PMID: 24720323 BACKGROUND

• 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.

  PMID: 24942508 BACKGROUND

• Trampuz A, Zimmerli W. Prosthetic joint infections: update in diagnosis and treatment. Swiss Med Wkly. 2005 Apr 30;135(17-18):243-51. doi: 10.4414/smw.2005.10934.

  PMID: 15965826 BACKGROUND

• 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.

  PMID: 21757977 BACKGROUND

• 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. doi: 10.1177/1750458913023001-203.

  PMID: 23413532 BACKGROUND

• 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.

  PMID: 19308319 BACKGROUND

• 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.

  PMID: 21721875 BACKGROUND

• Lefebvre A, Saliou P, Lucet JC, Mimoz O, Keita-Perse O, Grandbastien B, Bruyere F, Boisrenoult P, Lepelletier D, Aho-Glele 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.

  PMID: 26320612 BACKGROUND

• Kjonniksen I, Andersen BM, Sondenaa VG, Segadal L. Preoperative hair removal--a systematic literature review. AORN J. 2002 May;75(5):928-38, 940. doi: 10.1016/s0001-2092(06)61457-9.

  PMID: 12063942 BACKGROUND

• 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.

  PMID: 27875033 BACKGROUND

• Tanner J, Woodings D, Moncaster K. Preoperative hair removal to reduce surgical site infection. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004122. doi: 10.1002/14651858.CD004122.pub3.

  PMID: 16856029 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ditte Harder, Student

  Herlev og Gentofte Hospital, Ortopædkirurgisk Afdeling T

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ditte Harder, Student

CONTACT

+4538673364; ditte.marie.bak.harder@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to either the intervention group (preoperative electrical clipping) 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. Hair removal is performed with an electric clipper. 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. 4 microbiological samples will be taken during surgery from each participant using Copan ESwabs.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: February 15, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)