Iodine Impregnated Incision Drapes and Bacterial Recolonization in Simulated Knee Surgery. A Controlled Randomized Experimental Trial.

NCT02342561 | Completed Results

• 1 other identifier: S-20140060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of Iodine-impregnated self-adhesive plastic drapes (IIAD) on the quantity of skin bacteria, which is a known factor in the development of surgical site infections in orthopedic surgery. 16 patients scheduled for total knee replacement surgery (TKA) are recruited for participation in an intervention performed at the orthopedic ward of Odense University Hospital, Denmark. Right or left patient knee is randomized to receive draping with IIAD, while the other knee is not draped. Local standard preoperative procedure for knee surgery is then simulated. After 75 minutes both knee are sampled for bacterial quantity using the cup scrub method and samples are aerobically incubated. The bacterial growth of the IIAD and no-drape group are then compared using nonparametric statistics.

Conditions

Total Knee Replacement Surgery

Keywords

Infection; Drape; Ioban; Arthroplasty; Knee; Cylinder Sampling; Bacteria

Outcome Measures

Primary Outcomes (1)

• Bacterial Quantity

  The bacterial quantity of the skin in sampled using the cylinder sampling method and incubated for 36-48 hours. Manually counted growth is reported as log10 Colony forming units (CFU)/cm\^2

  Measured after skin disinfection and 75 minutes after drape application

Secondary Outcomes (1)

• Description of Bacterial Skin Flora

  Samples collected 75 minutes after drape application are analysed

Study Arms (2)

Intervention knees (Drape side)

EXPERIMENTAL

One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.

Device: Ioban 2 incision drape, 3M

Control knees (no-drape side)

NO INTERVENTION

The knee that is not drape is left uncovered during the intervention.

Interventions

Ioban 2 incision drape, 3M DEVICE

The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.

Also known as: Ioban 2 antimicrobial incision drape, 3M

Intervention knees (Drape side)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is scheduled for primary knee replacement surgery (TKA).

You may not qualify if:

• Patient age under 50 year
• Patient is allergic to iodine
• Patient has received antibiotic treatment within 4 weeks of intervention.
• Patient suffers from a chronic skin disease with lesions in the knee area
• Patient has lesions of the skin due to trauma suffered within 1 week of intervention.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Ortopeadic research Unit, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (38)

• Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.

  PMID: 10219875 BACKGROUND

• Anderson DJ, Kaye KS, Classen D, Arias KM, Podgorny K, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Klompas M, Lo E, Marschall J, Mermel LA, Nicolle L, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S51-61. doi: 10.1086/591064. No abstract available.

  PMID: 18840089 BACKGROUND

• Webster J, Alghamdi AA. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006353. doi: 10.1002/14651858.CD006353.pub2.

  PMID: 17943905 BACKGROUND

• Johnston DH, Fairclough JA, Brown EM, Morris R. Rate of bacterial recolonization of the skin after preparation: four methods compared. Br J Surg. 1987 Jan;74(1):64. doi: 10.1002/bjs.1800740121. No abstract available.

  PMID: 3828740 BACKGROUND

• Lewis DA, Leaper DJ, Speller DC. Prevention of bacterial colonization of wounds at operation: comparison of iodine-impregnated ('Ioban') drapes with conventional methods. J Hosp Infect. 1984 Dec;5(4):431-7. doi: 10.1016/0195-6701(84)90013-6.

  PMID: 6085099 BACKGROUND

• Brush M. Surgical preparation and site acces: Testing´s stepchild. In: Paulson DS, editor. Handbook of topical antimicrobials: Industrial applications in consumer products and pharmaceutical. New York: Marcel Dekker Inc; 2003. p. 197-220.

  BACKGROUND

• Selwyn S. Evaluating skin disinfectants in vivo by excision biopsy and other methods. J Hosp Infect. 1985 Mar;6 Suppl A:37-43. doi: 10.1016/s0195-6701(85)80044-x. No abstract available.

  PMID: 2860174 BACKGROUND

• So BK, Chu CC, Ho PL, Chow KH, Leung JN, Lee IY, Lin CK, Lee CK. Evaluation of two chlorhexidine-alcohol-based skin disinfectants in blood donation setting. Vox Sang. 2014 May;106(4):316-21. doi: 10.1111/vox.12107.

  PMID: 24877234 BACKGROUND

• Fleischmann W, Meyer H, von Baer A. Bacterial recolonization of the skin under a polyurethane drape in hip surgery. J Hosp Infect. 1996 Oct;34(2):107-16. doi: 10.1016/s0195-6701(96)90135-8.

  PMID: 8910752 BACKGROUND

• Wilson SE. Microbial sealing: a new approach to reducing contamination. J Hosp Infect. 2008 Nov;70 Suppl 2:11-4. doi: 10.1016/S0195-6701(08)60018-3.

  PMID: 19022116 BACKGROUND

• 3M HC. 3M incise drapes 2014 [cited 2014 Oktober 29th]. Available from: http://solutions.3m.com/wps/portal/3M/en_US/IPD-NA/3M-Infection-Prevention/products/catalog/~/All-3M-Products/Industry-and-Professionals/Medical-Supplies-Software/Infection-Prevention-Products/Incise-Drapes?N=5716450&rt=c3.

  BACKGROUND

• Chiu KY, Lau SK, Fung B, Ng KH, Chow SP. Plastic adhesive drapes and wound infection after hip fracture surgery. Aust N Z J Surg. 1993 Oct;63(10):798-801. doi: 10.1111/j.1445-2197.1993.tb00343.x.

  PMID: 8274123 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

• Marples RR, Kligman AM. Growth of bacteria under adhesive tapes. Arch Dermatol. 1969 Jan;99(1):107-10. No abstract available.

  PMID: 5761791 BACKGROUND

• Dewan PA, Van Rij AM, Robinson RG, Skeggs GB, Fergus M. The use of an iodophor-impregnated plastic incise drape in abdominal surgery--a controlled clinical trial. Aust N Z J Surg. 1987 Nov;57(11):859-63. doi: 10.1111/j.1445-2197.1987.tb01281.x.

  PMID: 3326567 BACKGROUND

• Kramer A, Assadian O, Lademann J. Prevention of postoperative wound infections by covering the surgical field with iodine-impregnated incision drape (Ioban 2). GMS Krankenhhyg Interdiszip. 2010 Sep 21;5(2):Doc08. doi: 10.3205/dgkh000151.

  PMID: 20941338 BACKGROUND

• Nichols RL. Surgical infections: prevention and treatment--1965 to 1995. Am J Surg. 1996 Jul;172(1):68-74. doi: 10.1016/S0002-9610(96)00049-9.

  PMID: 8686806 BACKGROUND

• Danish Orthopeadic Society. Reference program, Primary knee arthroplastic surgery. 2007.

  BACKGROUND

• Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson UG. Bacterial recolonization of the skin and wound contamination during cardiac surgery: a randomized controlled trial of the use of plastic adhesive drape compared with bare skin. J Hosp Infect. 2013 Jun;84(2):151-8. doi: 10.1016/j.jhin.2013.02.011. Epub 2013 Apr 25.

  PMID: 23623487 BACKGROUND

• Fairclough JA, Johnson D, Mackie I. The prevention of wound contamination by skin organisms by the pre-operative application of an iodophor impregnated plastic adhesive drape. J Int Med Res. 1986;14(2):105-9. doi: 10.1177/030006058601400210.

  PMID: 3699240 BACKGROUND

• Bashir MH, Olson LK, Walters SA. Suppression of regrowth of normal skin flora under chlorhexidine gluconate dressings applied to chlorhexidine gluconate-prepped skin. Am J Infect Control. 2012 May;40(4):344-8. doi: 10.1016/j.ajic.2011.03.030. Epub 2011 Jul 7.

  PMID: 21737178 BACKGROUND

• Aly R, Bayles C, Maibach H. Restriction of bacterial growth under commercial catheter dressings. Am J Infect Control. 1988 Jun;16(3):95-100. doi: 10.1016/0196-6553(88)90045-4.

  PMID: 3408019 BACKGROUND

• Callahan JL, Wesorick B. Bacterial growth under a transparent dressing. Am J Infect Control. 1987 Dec;15(6):231-7. doi: 10.1016/0196-6553(87)90116-7.

  PMID: 3439642 BACKGROUND

• Waxman BP, Easmon CS, Dudley HA. Skin bacteria and Op Site chest dressings. Clin Nutr. 1985 Feb;4(1):29-34. doi: 10.1016/0261-5614(85)90034-2.

  PMID: 16831700 BACKGROUND

• Faoagali J, Fong J, George N, Mahoney P, O'Rourke V. Comparison of the immediate, residual, and cumulative antibacterial effects of Novaderm R,* Novascrub R,* Betadine Surgical Scrub, Hibiclens, and liquid soap. Am J Infect Control. 1995 Dec;23(6):337-43. doi: 10.1016/0196-6553(95)90263-5.

  PMID: 8821108 BACKGROUND

• Wade JJ, Casewell MW. The evaluation of residual antimicrobial activity on hands and its clinical relevance. J Hosp Infect. 1991 Jun;18 Suppl B:23-8. doi: 10.1016/0195-6701(91)90259-b.

  PMID: 1679443 BACKGROUND

• Sogawa Y, Kobayashi H. Comparison of residual antimicrobial activity of chlorhexidine-containing antiseptics: An express report. Journal of Healthcare-associated Infection. 2010;2:32-6.

  BACKGROUND

• Ritter MA, Campbell ED. Retrospective evaluation of an iodophor-incorporated antimicrobial plastic adhesive wound drape. Clin Orthop Relat Res. 1988 Mar;(228):307-8.

  PMID: 3342583 BACKGROUND

• Billhimer WL, Berge CA, Englehart JS, Rains GY, Keswick BH. A modified cup scrub method for assessing the antibacterial substantivity of personal cleansing products. J Cosmet Sci. 2001 Nov-Dec;52(6):369-75.

  PMID: 11773954 BACKGROUND

• Williamson P, Kligman AM. A new method for the quantitative investigation of cutaneous bacteria. J Invest Dermatol. 1965 Dec;45(6):498-503. doi: 10.1038/jid.1965.164. No abstract available.

  PMID: 5321315 BACKGROUND

• Hambraeus A, Hoborn J, Whyte W. Skin sampling-validation of a pad method and comparison with commonly used methods. J Hosp Infect. 1990 Jul;16(1):19-27. doi: 10.1016/0195-6701(90)90045-p.

  PMID: 1974903 BACKGROUND

• Beausoleil CM. A guide for validation of neutralizer systems. In: Paulson DS, editor. Handbook of topical antimicrobials: Industrial applications in consumer products and pharmaceutical. New York: Marcel Dekker Inc; 2003. p. 365-76.

  BACKGROUND

• Kampf G. What is left to justify the use of chlorhexidine in hand hygiene? J Hosp Infect. 2008 Oct;70 Suppl 1:27-34. doi: 10.1016/S0195-6701(08)60008-0.

  PMID: 18994679 BACKGROUND

• Shimizu M, Okuzumi K, Yoneyama A, Kunisada T, Araake M, Ogawa H, Kimura S. In vitro antiseptic susceptibility of clinical isolates from nosocomial infections. Dermatology. 2002;204 Suppl 1:21-7. doi: 10.1159/000057720.

  PMID: 12011516 BACKGROUND

• Zamany A, Spangberg LS. An effective method of inactivating chlorhexidine. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 May;93(5):617-20. doi: 10.1067/moe.2002.122346.

  PMID: 12075214 BACKGROUND

• Bloom E, Aly R, Maibach HI. Quantitation of skin bacteria: lethality of the wash solution used to remove bacteria. Acta Derm Venereol. 1979;59(5):460-3.

  PMID: 93373 BACKGROUND

• Reichel M, Heisig P, Kampf G. Pitfalls in efficacy testing--how important is the validation of neutralization of chlorhexidine digluconate? Ann Clin Microbiol Antimicrob. 2008 Dec 2;7:20. doi: 10.1186/1476-0711-7-20.

  PMID: 19046465 BACKGROUND

• Cecilio. RL PF, Palileo. E,. Microbiological efficacy of Chlorhexidine: An In Vitro Study on 400 Bacterial Isolates from Four Metro Manila Hospitals. Phil J Microbial Dis. 1983;12:7-13.

  BACKGROUND

MeSH Terms

Conditions

Infections

Results Point of Contact

• Title: Nikolaj Milandt, Undergraduate researcher
• Organization: The Orthopaedic Research Unit, Department of Orthopaedic Surgery and Trauma, Odense University Hospital, Denmark

nikolaj.rongsted.milandt@rsyd.dk

26616611

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: stud. cand. med, BA Clinical Biomechanics

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 21, 2015
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 11, 2015
• Results First Posted: December 11, 2015

Record last verified: 2015-11

Locations

DK (1)