Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery

Surgical Wound Infection Clinical Trial

— PROTOP  

Official title:

PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574090
• Other study ID #: 1234
• Status: Completed
• Phase: Phase 4
• Start date: October 20, 2020
• Est. completion date: June 11, 2023

Study information

• Verified date: June 2023
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Is a clinical trial phase IV prospective, blind, controlled and random allocation of treatment with the active principle of amoxicillin 1000mg and 200mg Clavulanic acid, administered topically and dissolved in 500 ml of saline 0.9%. To demonstrate its effectiveness in the surgical wound infection prophylaxis be used in contaminated surgery and be compared its effectiveness with the topical administration of normal saline only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: June 11, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Postoperative Wound Infection
• Postoperative Wound Infection Superficial Incisional
• Preventive Therapy
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Drug:
• Amoxicillin Clavulanate
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.
• Physiological Saline
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.

Locations

Country	Name	City	State
Spain	Hospital General de Granollers	Granollers	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya	Hospital de Granollers

Country where clinical trial is conducted

Spain, 

References & Publications (47)

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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.2014.01.0 — View Citation

* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	reduction of hospital stay	Effect of the protocol of topical prophylaxis in the reduction of hospital stay	30 days
Secondary	Bacterial charge	Effect of topical prophylaxis protocol on reducing bacterial charge	30 days
Secondary	Bacterial resistance	Effect of topical prophylaxis protocol on Bacterial resistance	30 days

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