NCT03574090

Brief Summary

The main objective is to study the efficacy of topical antibiotic therapy with Amoxicillin / Clavulanic acid in the prevention of surgical wound infection in patients undergoing to colorectal surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
2.3 years until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2.6 years

First QC Date

May 30, 2018

Last Update Submit

June 11, 2023

Conditions

Surgical Wound InfectionPostoperative Wound InfectionPostoperative Wound Infection Superficial IncisionalPreventive Therapy

Keywords

topical antibioticsurgical wound infectionprevention of surgical wound infection

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI

    Evaluation of the effect of topical antibiòtic ( Amoxicillin 1000mg and 200mg of Clavulanic acid dissolved in 500 milliliters of 0.9% Physiological Serum ) prophylaxis on the incidence of Surgical Site Infection in surgery due to emergency intra-abdominal infection

    30 days

Secondary Outcomes (3)

  • reduction of hospital stay

    30 days

  • Bacterial charge

    30 days

  • Bacterial resistance

    30 days

Study Arms (2)

amoxicillin clavulanate

EXPERIMENTAL

1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum.

Drug: Amoxicillin ClavulanateDrug: Physiological Saline

Physiological Saline

ACTIVE COMPARATOR

500 milliliters of 0.9% Physiological Serum.

Drug: Physiological Saline

Interventions

Amoxicillin ClavulanateDRUG

To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.

Also known as: 1000 mg amoxicillin and 200mg clavulanic acid.
amoxicillin clavulanate
Physiological SalineDRUG

To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.

Also known as: 500 milliliters of 0.9% Physiological Serum
Physiological Salineamoxicillin clavulanate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age.
  • Patients who require urgent surgical intervention and who come from the emergency service
  • Patients affected by complicated intra-abdominal infection with peritonitis of more than one abdominal compartment or intra-abdominal abscess requiring open surgical intervention.

You may not qualify if:

  • Women patients with positive pregnancy test.
  • Patients with primary peritonitis and liver cirrhosis.
  • Patients who have received antibiotic treatment during the 72 hours prior to the surgical intervention (except that administered to UCIES as a treatment dose of the same process)
  • Patients allergic to the antibiotic used in the study.
  • Patients who have undergone a surgical procedure of recently opened abdomen (up to 30 days before surgery), a prosthesis of synthetic material (mesh) or to which the surgical wound can not be closed according to the surgeon's criteria.
  • Patients with an unfavorable life prognosis (ASA 5).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

Related Publications (47)

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  • Lazar HL, Ketchedjian A, Haime M, Karlson K, Cabral H. Topical vancomycin in combination with perioperative antibiotics and tight glycemic control helps to eliminate sternal wound infections. J Thorac Cardiovasc Surg. 2014 Sep;148(3):1035-8; 1038-40. doi: 10.1016/j.jtcvs.2014.06.045. Epub 2014 Jul 2.

    PMID: 25129595RESULT

  • Garner JS. CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised. Infect Control. 1986 Mar;7(3):193-200. doi: 10.1017/s0195941700064080. No abstract available.

    PMID: 3633903RESULT

  • Abdullah KG, Attiah MA, Olsen AS, Richardson A, Lucas TH. Reducing surgical site infections following craniotomy: examination of the use of topical vancomycin. J Neurosurg. 2015 Dec;123(6):1600-4. doi: 10.3171/2014.12.JNS142092. Epub 2015 Jun 19.

    PMID: 26090835RESULT

  • Kang DG, Holekamp TF, Wagner SC, Lehman RA Jr. Intrasite vancomycin powder for the prevention of surgical site infection in spine surgery: a systematic literature review. Spine J. 2015 Apr 1;15(4):762-70. doi: 10.1016/j.spinee.2015.01.030. Epub 2015 Jan 28.

    PMID: 25637469RESULT

  • Kirby JP, Mazuski JE. Prevention of surgical site infection. Surg Clin North Am. 2009 Apr;89(2):365-89, viii. doi: 10.1016/j.suc.2009.01.001.

    PMID: 19281889RESULT

  • Krukowski ZH, Irwin ST, Denholm S, Matheson NA. Preventing wound infection after appendicectomy: a review. Br J Surg. 1988 Oct;75(10):1023-33. doi: 10.1002/bjs.1800751023.

    PMID: 3064867RESULT

  • 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: 10219875RESULT

  • Musters GD, Burger JW, Buskens CJ, Bemelman WA, Tanis PJ. Local Application of Gentamicin in the Prophylaxis of Perineal Wound Infection After Abdominoperineal Resection: A Systematic Review. World J Surg. 2015 Nov;39(11):2786-94. doi: 10.1007/s00268-015-3159-5.

    PMID: 26170157RESULT

  • Leaper D, Burman-Roy S, Palanca A, Cullen K, Worster D, Gautam-Aitken E, Whittle M; Guideline Development Group. Prevention and treatment of surgical site infection: summary of NICE guidance. BMJ. 2008 Oct 28;337:a1924. doi: 10.1136/bmj.a1924. No abstract available.

    PMID: 18957455RESULT

  • Rutten HJ, Nijhuis PH. Prevention of wound infection in elective colorectal surgery by local application of a gentamicin-containing collagen sponge. Eur J Surg Suppl. 1997;(578):31-5.

    PMID: 9167147RESULT

  • Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.

    PMID: 12603990RESULT

  • Nichols RL. Preventing surgical site infections: a surgeon's perspective. Emerg Infect Dis. 2001 Mar-Apr;7(2):220-4. doi: 10.3201/eid0702.010214.

    PMID: 11294711RESULT

  • Serrano-Heranz R. [Antimicrobial prophylaxis for surgery]. Rev Esp Quimioter. 2006 Dec;19(4):323-31. No abstract available. Spanish.

    PMID: 17235400RESULT

  • Rosen HR, Marczell AP, Czerwenka E, Stierer MO, Spoula H, Wasl H. Local gentamicin application for perineal wound healing following abdominoperineal rectum excision. Am J Surg. 1991 Nov;162(5):438-41. doi: 10.1016/0002-9610(91)90256-d.

    PMID: 1951905RESULT

  • Schultz A, Jorgensen PM, Jorgensen SP. Septic complications after appendicectomy for perforated appendicitis. A controlled clinical trial metronidazole and topical ampicillin. Acta Chir Scand. 1983;149(5):517-20.

    PMID: 6356732RESULT

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    PMID: 12439804RESULT

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    PMID: 15909433RESULT

  • Sociedad Española de Medicina Preventiva, Salud Pública e Higiene (SEMPSPH). (2015). Evolución EPINE 1990-2015 de la prevalencia de las infecciones nosocomiales en los hospitales españoles. EPINE. 1990-2015. Madrid.

    RESULT

  • Vasavada AR, Gajjar D, Raj SM, Vasavada V, Vasavada V. Comparison of 2 moxifloxacin regimens for preoperative prophylaxis: prospective randomized triple-masked trial. Part 1: aqueous concentration of moxifloxacin. J Cataract Refract Surg. 2008 Aug;34(8):1379-82. doi: 10.1016/j.jcrs.2008.04.027.

    PMID: 18655991RESULT

  • Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet. 1986 Feb 8;1(8476):311-3. doi: 10.1016/s0140-6736(86)90838-x.

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    RESULT

  • Yan H, He J, Chen S, Yu S, Fan C. Intrawound application of vancomycin reduces wound infection after open release of post-traumatic stiff elbows: a retrospective comparative study. J Shoulder Elbow Surg. 2014 May;23(5):686-92. doi: 10.1016/j.jse.2014.01.049.

    PMID: 24745317RESULT

  • Badia JM, Martinez-Rodenas F, Oms LM, Valverde J, Franch G, Rosales A, Serrano R, Sitges-Serra A. [A randomized prospective study of antibiotic prophylaxis compared to lavage of the surgical wound in nonperforating appendicitis]. Med Clin (Barc). 1994 Jul 9;103(6):201-4. Spanish.

    PMID: 7967862RESULT

  • Badia JM, de la Torre R, Farre M, Gaya R, Martinez-Rodenas F, Sancho JJ, Sitges-Serra A. Inadequate levels of metronidazole in subcutaneous fat after standard prophylaxis. Br J Surg. 1995 Apr;82(4):479-82. doi: 10.1002/bjs.1800820417.

    PMID: 7613890RESULT

  • Badia JM, Torres JM, Tur C, Sitges-Serra A. Saline wound irrigation reduces the postoperative infection rate in guinea pigs. J Surg Res. 1996 Jul 1;63(2):457-9. doi: 10.1006/jsre.1996.0292.

    PMID: 8661242RESULT

  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

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  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

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  • Badia JM, Del Toro MD, Navarro Gracia JF, Balibrea JM, Herruzo R, Gonzalez Sanchez C, Lozano Garcia J, Rubio Perez I, Guirao X, Soria-Aledo V, Orti-Lucas R; Surgical Location Infection Prevention Program Working Group of the Observatory of Infection in Surgery. Surgical Infection Reduction Program of the Observatory of Surgical Infection (PRIQ-O): Delphi prioritization and consensus document on recommendations for the prevention of surgical site infection. Cir Esp (Engl Ed). 2023 Apr;101(4):238-251. doi: 10.1016/j.cireng.2022.11.009. Epub 2022 Nov 24.

    PMID: 36427782RESULT

  • Foschi D, Yakushkina A, Cammarata F, Lamperti G, Colombo F, Rimoldi S, Antinori S, Sampietro GM. Surgical site infections caused by multi-drug resistant organisms: a case-control study in general surgery. Updates Surg. 2022 Oct;74(5):1763-1771. doi: 10.1007/s13304-022-01243-3. Epub 2022 Mar 19.

    PMID: 35304900RESULT

  • Gomes ET, Carbogim FDC, Lins RS, Lins-Filho RLM, Poveda VB, Puschel VAA. Effectiveness of supplemental oxygenation to prevent surgical site infections: A systematic review with meta-analysis. Rev Lat Am Enfermagem. 2022 Oct 7;30:e3648. doi: 10.1590/1518-8345.6106.3648. eCollection 2022.

    PMID: 36228236RESULT

  • Arroyo-Garcia N, Badia JM, Vazquez A, Pera M, Pares D, Limon E, Almendral A, Piriz M, Diez C, Fraccalvieri D, Lopez-Contreras J, Pujol M; Members of the VINCat Colorectal Surveillance Team; VINCat Program. An interventional nationwide surveillance program lowers postoperative infection rates in elective colorectal surgery. A cohort study (2008-2019). Int J Surg. 2022 Jun;102:106611. doi: 10.1016/j.ijsu.2022.106611. Epub 2022 Apr 12.

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  • Fuglestad MA, Tracey EL, Leinicke JA. Evidence-based Prevention of Surgical Site Infection. Surg Clin North Am. 2021 Dec;101(6):951-966. doi: 10.1016/j.suc.2021.05.027.

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  • Badia JM, Casey AL, Rubio-Perez I, Arroyo-Garcia N, Espin E, Biondo S, Balibrea JM. Awareness of Practice and Comparison with Best Evidence in Surgical Site Infection Prevention in Colorectal Surgery. Surg Infect (Larchmt). 2020 Apr;21(3):218-226. doi: 10.1089/sur.2019.203. Epub 2019 Nov 14.

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  • Badia JM, Casey AL, Rubio-Perez I, Crosby C, Arroyo-Garcia N, Balibrea JM. A survey to identify the breach between evidence and practice in the prevention of surgical infection: Time to take action. Int J Surg. 2018 Jun;54(Pt A):290-297. doi: 10.1016/j.ijsu.2018.04.038. Epub 2018 Apr 25.

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  • Kamboj M, Childers T, Sugalski J, Antonelli D, Bingener-Casey J, Cannon J, Cluff K, Davis KA, Dellinger EP, Dowdy SC, Duncan K, Fedderson J, Glasgow R, Hall B, Hirsch M, Hutter M, Kimbro L, Kuvshinoff B, Makary M, Morris M, Nehring S, Ramamoorthy S, Scott R, Sovel M, Strong V, Webster A, Wick E, Aguilar JG, Carlson R, Sepkowitz K. Risk of Surgical Site Infection (SSI) following Colorectal Resection Is Higher in Patients With Disseminated Cancer: An NCCN Member Cohort Study. Infect Control Hosp Epidemiol. 2018 May;39(5):555-562. doi: 10.1017/ice.2018.40. Epub 2018 Mar 19.

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  • Farach SM, Kelly KN, Farkas RL, Ruan DT, Matroniano A, Linehan DC, Moalem J. Have Recent Modifications of Operating Room Attire Policies Decreased Surgical Site Infections? An American College of Surgeons NSQIP Review of 6,517 Patients. J Am Coll Surg. 2018 May;226(5):804-813. doi: 10.1016/j.jamcollsurg.2018.01.005. Epub 2018 Feb 28.

    PMID: 29408507RESULT

  • Pieper D, Rombey T, Doerner J, Rembe JD, Zirngibl H, Zarras K, Ambe PC. The role of saline irrigation prior to wound closure in the reduction of surgical site infection: protocol for a systematic review and meta-analysis. Syst Rev. 2018 Oct 5;7(1):152. doi: 10.1186/s13643-018-0813-7.

    PMID: 30286812RESULT

  • Nelson RL, Iqbal NM, Kravets A, Khateeb R, Raza M, Siddiqui M, Taha I, Tummala A, Epple R, Huang S, Wen M. Topical antimicrobial prophylaxis in colorectal surgery for the prevention of surgical wound infection: a systematic review and meta-analysis. Tech Coloproctol. 2018 Aug;22(8):573-587. doi: 10.1007/s10151-018-1814-1. Epub 2018 Jul 17.

    PMID: 30019145RESULT

Related Links

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Amoxicillin-Potassium Clavulanate CombinationAmoxicillinClavulanic Acid

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Josep Maria Badia Perez, PH. D

    Universitat Internacional de Catalunya

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
In the operating room area we will keep a notebook with the random number sheet and a box with the numbered envelopes and containing the treatment to follow: physiological saline alone or physiological saline with antibiotic. At the end of the surgery and before closing the abdominal wall, it is definitively informed to the nurse whether or not to recruit them, a case number is assigned chronologically and in the random number sheet corresponds to an envelope containing one of the two treatments. Dilution is performed with 10cc of physiological saline solution with or without antibiotic in the outside of the operating room and then it is incorporated into the 500cc bottle of physiological saline once opened in a sterile way. We used according to the usual protocol.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

May 30, 2018

First Posted

June 29, 2018

Study Start

October 20, 2020

Primary Completion

May 30, 2023

Study Completion

June 11, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

ES(1)