Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery

Status Completed

Clinical Trial Summary

A prospective, randomized study was performed. The patients were randomized into 2 groups: those patients undergoing subcutaneous vitamin E ointment application (Group 1) and those patients who not (Group 2).

Incisional surgical site infection (SSI), microbiological cultures from the infected surgical wounds, postoperative pain and acute phase reactants were investigated.

Clinical Trial Description

A prospective, randomized study was performed. The patients were randomized into 2 groups: those patients undergoing a subcutaneous sterile vitamin E acetate ointment application (Group 1) and those patients who did not receive this vitamin E ointment application (Group 2).

Before the skin stapling and after the subcutaneous irrigation with normal saline, sterile Vitamin E acetate ointment (FilmeOft, Hulka SRL, Rovigo, Italy) was applied in the subcutaneous tissue; 2 ml were applied in the suprapubic incision and 0.5 ml in the rest of port sites.

Incisional SSI, microbiological cultures from the infected surgical wounds, postoperative pain was evaluated 24 hours after surgery by means of a Visual Analogic Scale (VAS), ranging from 0 mm (complete absence of pain) to 100 mm (unbearable pain) and acute phase reactants (white cell count (WBC), fibrinogen and C reactive protein) 48 hours after surgery were investigated. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02820948
Study type	Interventional
Source	Hospital General Universitario Elche
Contact
Status	Completed
Phase	Phase 3
Start date	January 2015
Completion date	March 2016

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04096885` - The Inselspital Surgical Cohort Study
Terminated	`NCT03820648` - Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy	N/A
Completed	`NCT04067843` - Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study	N/A
Terminated	`NCT04042077` - Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections	Phase 3
Completed	`NCT05841576` - Anaesthetic Management Guided by COMET Measurements	N/A
Withdrawn	`NCT05338281` - NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT	N/A
Recruiting	`NCT03042091` - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery	Early Phase 1
Completed	`NCT01697748` - Prospective Study on Cesarean Wound Outcomes	N/A
Terminated	`NCT01789697` - Text Message Study	N/A
Recruiting	`NCT05966961` - Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Recruiting	`NCT05077592` - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections	Phase 4
Recruiting	`NCT05502380` - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery	Phase 3
Recruiting	`NCT05763602` - PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)	Phase 4
Recruiting	`NCT03221023` - Intrawound Vancomycin Prophylaxis for Neural Stimulator	Phase 2/Phase 3
Completed	`NCT03257202` - Topical Treatment and Prevalence of P. Acnes	Phase 2
Completed	`NCT06154720` - Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
Not yet recruiting	`NCT06465901` - A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI	N/A
Not yet recruiting	`NCT04820075` - Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery	N/A
Recruiting	`NCT03561376` - Zinc Oxide Versus Petrolatum Following Skin Surgery	Early Phase 1
Not yet recruiting	`NCT04496180` - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy	N/A