Effect of Skin Antisepsis After Skin Closure on Wound Infection After Abdominal Surgery for Sepsis: a Preliminary Report

NCT05896462 | Completed DMC

• 1 other identifier: UI/EC/19/0158
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The benefits of pre-incision skin antisepsis is well established. However, the role of skin antisepsis after skin closure in abdominal surgery for sepsis is not well reported. This study examined whether the use of skin antisepsis after closing the skin during a surgery for an infection within the abdomen would have an effect on wound infection in the post-operative period. The patients - aged 18 years and above - were categorised into two groups: the first had antisepsis with povidone iodine-soaked gauze while the second group of patients had their wound only dressed with a dry sterile gauze. Both groups were then compared for the occurrence of surgical site infection and other post-operative outcomes. The null hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have no effect on the incidence of post-operative Surgical Site Infection while the alternative hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have an effect on the incidence of post-operative Surgical Site Infection.

Conditions

Antisepsis

Keywords

Antisepsis; Skin Closure; Abdominal Surgery; Sepsis

Outcome Measures

Primary Outcomes (1)

• SSI (Surgical Site Infection)

  Incidence of surgical site infection

  From day 3 post-operatively up to 28 days post-operatively

Secondary Outcomes (1)

• LOS (Length of Stay)

  From day 1 post-operatively up to the day of discharge

Study Arms (2)

Povidone iodine (PI) group

ACTIVE COMPARATOR

10% povidone iodine-soaked gauze dressing was used to cover the apposed skin edge.

Other: 10% povidone iodine

Control (C) group

NO INTERVENTION

The apposed skin edge covered with dry sterile gauze

Interventions

10% povidone iodine OTHER

The apposed skin edge was covered with 10% povidone iodine-soaked gauze dressing

Povidone iodine (PI) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients requiring laparotomy for sepsis aged 18 years and above

You may not qualify if:

• All cases of clean and clean-contaminated abdominal surgeries

Sponsors & Collaborators

• Ikechukwu Bartholomew Ulasi: lead

Study Sites (1)

University College Hospital

Ibadan, Oyo State, 200212, Nigeria

Location

Related Publications (4)

• Maiwald M, Chan ES. The forgotten role of alcohol: a systematic review and meta-analysis of the clinical efficacy and perceived role of chlorhexidine in skin antisepsis. PLoS One. 2012;7(9):e44277. doi: 10.1371/journal.pone.0044277. Epub 2012 Sep 5.

  PMID: 22984485 BACKGROUND

• Reichel M, Heisig P, Kohlmann T, Kampf G. Alcohols for skin antisepsis at clinically relevant skin sites. Antimicrob Agents Chemother. 2009 Nov;53(11):4778-82. doi: 10.1128/AAC.00582-09. Epub 2009 Sep 8.

  PMID: 19738017 BACKGROUND

• Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003949. doi: 10.1002/14651858.CD003949.pub3.

  PMID: 23543526 BACKGROUND

• Justinger C, Slotta JE, Ningel S, Graber S, Kollmar O, Schilling MK. Surgical-site infection after abdominal wall closure with triclosan-impregnated polydioxanone sutures: results of a randomized clinical pathway facilitated trial (NCT00998907). Surgery. 2013 Sep;154(3):589-95. doi: 10.1016/j.surg.2013.04.011. Epub 2013 Jul 13.

  PMID: 23859304 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ikechukwu B. Ulasi

  University College Hospital, Ibadan

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Having closed the skin and cleaned with savlon and 70% isopropyl alcohol, patients in the C group had the apposed skin edge covered with dry sterile gauze while in PI group, 10% povidone iodine-soaked gauze dressing was used to cover the apposed skin edge

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 9, 2023
• Study Start: August 19, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 29, 2022
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)