The Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions

NCT03357419 | Withdrawn

• 1 other identifier: 0569-17 RMB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of surgical site infection (SSI) infection in clean dermatologic surgery is very low, between 1-3%. Studies have demonstrated a much higher infection rate in skin excision surgeries in the lower limbs, up to 10% in most studies, and even 35.7% infection rate in a recent study from Australia. To our knowledge, there are no clinical trials demonstrating the efficacy of prophylactic antibiotic given prior to skin lesion excision from the lower limbs.

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

• The primary end point is absence of infection after 1 month follow-up.

  Wounds will be assessed for infection by the doctor at the time of removal of sutures, or sooner if the patient had complaints about the wound. The definition of SSI and its classification to superficial or deep will be based on the presence of any of the following criteria that were adapted from the Centre for Disease Control and Prevention (CDC) definition for superficial SSI \[42\]. The primary outcome will consist of any SSI, superficial or deep.

  1-2 years

Study Arms (2)

prophylactic antibiotic

ACTIVE COMPARATOR

Each active arm patient will be given the tested drug on admission, 30-60 minutes before the surgery, by the nurses. 2 g dose of cephalexin (or Clindamycin 600 mg for patients suffering from allergy) will be given once, orally, 30-60 minutes prior to skin lesion excision

Drug: Cephalexin

placebo oral capsule

PLACEBO COMPARATOR

Each placebo arm patient will be given the placebo drug on admission, 30-60 minutes before the surgery, by the nurses

Drug: Placebo oral capsule

Interventions

Cephalexin DRUG

The subjects will be randomized, at the operation day, to one of two treatment groups: * group 1: prophylactic antibiotic * group 2: placebo oral capsule * Sealed envelopes, numbered according to the randomization dose, containing the drug or placebo will be prepared in advance and provided to the patient following randomization. * Each patient will be given the randomized drug on admission, 30-60 minutes before the surgery, by the nurses.

Also known as: Clindamycin hydrochloride

prophylactic antibiotic

Placebo oral capsule DRUG

The subjects will be randomized, at the operation day, to one of two treatment groups: * group 1: prophylactic antibiotic * group 2: placebo * Sealed envelopes, numbered according to the randomization dose, containing the drug or placebo will be prepared in advance and provided to the patient following randomization. * Each patient will be given the randomized drug on admission, 30-60 minutes before the surgery, by the nurses.

placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting for skin excision from the thigh, shin or foot, in the Rambam medical center

You may not qualify if:

• Younger than 18 years old.
• Not capable of providing informed consent.
• Declined to participate.
• Currently taking antibiotics.
• Surgeon feels they are clinically indicated for antibiotic treatment following excision.
• Lesions considered as contaminated/ infected prior to surgery.
• Excision not utilizing primary closure or skin graft.
• Patient unable to return for suture removal.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Department of Plastic Surgery, Rambam Medical Center

Haifa, 31096, Israel

Location

Related Publications (9)

• Wright TI, Baddour LM, Berbari EF, Roenigk RK, Phillips PK, Jacobs MA, Otley CC. Antibiotic prophylaxis in dermatologic surgery: advisory statement 2008. J Am Acad Dermatol. 2008 Sep;59(3):464-73. doi: 10.1016/j.jaad.2008.04.031.

  PMID: 18694679 BACKGROUND

• Maragh SL, Otley CC, Roenigk RK, Phillips PK; Division of Dermatologic Surgery, Mayo Clinic, Rochester, MN. Antibiotic prophylaxis in dermatologic surgery: updated guidelines. Dermatol Surg. 2005 Jan;31(1):83-91. doi: 10.1111/j.1524-4725.2005.31014.

  PMID: 15720101 BACKGROUND

• Rogues AM, Lasheras A, Amici JM, Guillot P, Beylot C, Taieb A, Gachie JP. Infection control practices and infectious complications in dermatological surgery. J Hosp Infect. 2007 Mar;65(3):258-63. doi: 10.1016/j.jhin.2006.09.030. Epub 2007 Jan 22.

  PMID: 17244515 BACKGROUND

• Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available.

  PMID: 1334988 BACKGROUND

• Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.

  PMID: 10196487 BACKGROUND

• Dixon AJ, Dixon MP, Askew DA, Wilkinson D. Prospective study of wound infections in dermatologic surgery in the absence of prophylactic antibiotics. Dermatol Surg. 2006 Jun;32(6):819-26; discussion 826-7. doi: 10.1111/j.1524-4725.2006.32167.x.

  PMID: 16792648 RESULT

• Amici JM, Rogues AM, Lasheras A, Gachie JP, Guillot P, Beylot C, Thomas L, Taieb A. A prospective study of the incidence of complications associated with dermatological surgery. Br J Dermatol. 2005 Nov;153(5):967-71. doi: 10.1111/j.1365-2133.2005.06861.x.

  PMID: 16225607 RESULT

• Burke JP. Maximizing appropriate antibiotic prophylaxis for surgical patients: an update from LDS Hospital, Salt Lake City. Clin Infect Dis. 2001 Sep 1;33 Suppl 2:S78-83. doi: 10.1086/321861.

  PMID: 11486303 RESULT

• Smith SC, Heal CF, Buttner PG. Prevention of surgical site infection in lower limb skin lesion excisions with single dose oral antibiotic prophylaxis: a prospective randomised placebo-controlled double-blind trial. BMJ Open. 2014 Jul 30;4(7):e005270. doi: 10.1136/bmjopen-2014-005270.

  PMID: 25079934 RESULT

MeSH Terms

Interventions

Cephalexin; Clindamycin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Officials

• Yehuda Ullmann, Proffesor

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, 1:1, double-blind, placebo controlled trial designed to evaluate the effect of prophylactic antibiotic on patients presenting for skin excision from lower limbs. Before the surgery patient's demographics, medical history, skin lesion's site, properties and size will be documented. During the surgery the size of the wound and the sutures used will be documented. Afterwards, the wound will be assed for signs of infection (criteria adapted from the Centre for Disease Control and Prevention definition for superficial SSI \[42\]) and other complications during the follow-up period as needed until sutures will be removed at our clinic.

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: November 29, 2017
• Study Start: March 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: March 27, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)