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Effect of Vitamin E Ointment on Incisional SSI in Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT02820948
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Brief 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.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Vitamin E ointment application Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Subcutaneous Sterile Vitamin E Ointment on Incisional Surgical-site Infection Following Elective Laparoscopic Colorectal Cancer Surgery
Study Start Date : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Experimental: Vitamin E ointment application
Before the skin stapling and after the subcutaneous irrigation with normal saline, sterile Vitamin E acetate ointment was applied in the subcutaneous tissue; 2 ml were applied in the suprapubic incision and 0.5 ml in the rest of port sites.
Drug: Vitamin E ointment application
Before the skin stapling and after the subcutaneous irrigation with normal saline, sterile Vitamin E acetate ointment was applied in the subcutaneous tissue; 2 ml were applied in the suprapubic incision and 0.5 ml in the rest of port sites.
Other Name: Subcutaneous sterile Vitamin E acetate ointment application

No Intervention: No Vitamin E ointment application
No vitamin E ointment was performed.



Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 30 days postoperatively ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of colorectal neoplasms and plans to undergo an elective laparoscopic surgery with curative aims

Exclusion Criteria:

  • Open surgical approach or conversion to laparotomy
  • Performance of a stoma
  • Immunodepression status
  • Anastomotic leak

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820948


Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Study Director: Damian Garcia Fundacion Jimenez Diaz

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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, David Alias, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02820948     History of Changes
Other Study ID Numbers: HRJC 16-6
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in scientific journal

Additional relevant MeSH terms:
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Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Infection
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents