Study to Evaluate DACC Dressings for the Prevention of Surgical Site Infections in Women Undergoing Caesarean Section.

NCT02168023 | Completed

• 2 other identifiers: DACC-1KB/127/2014
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical site infections (SSIs) constitute an important medical and socioeconomic problem worldwide. Despite the fact that the risk factors for SSIs were identified and the continuously increasing medical knowledge in the fields of tissue engineering, molecular biology and microbiology facilitated the development of numerous new recommendations and methods for management, in many cases the available options for successful treatment of post-operative wound infections remain limited. Non-treated or inappropriately treated SSIs often lead to necrosis of the surrounding tissues, wound dehiscence, formation of fistulas, or become sites of origin for systemic infections. Patients are exposed to risk of further complications and hospitalization time extends resulting in increased total treatment costs. Treatment prolongation affects also the quality of life and psychosocial functioning of patients with impaired wound healing. Considering the arguments above, appropriate prevention and management of infected post-surgical wounds is currently one of the priorities for the majority of invasive medical disciplines. Obstetrics constitute a field of medicine in which the issues associated with wound healing are particularly relevant. According to the literature data wound infections occur in approximately 1.8-11.3% of women undergoing caesarean section. Dialkylcarbamoyl chloride (DACC) is a fatty acid derivative that irreversibly binds microorganisms to the dressing fibres as a result of hydrophobic interaction. As the mechanism of DACC action is solely physical no chemical agents are released into the wound bed and the dressing could be safely used by women during puerperal period. The purpose of this randomized controlled study is to compare the effect of DACC impregnated dressing and standard surgical dressing in the prevention of SSIs in adult women following caesarean section. This study will also evaluate pre-, peri- and postoperative risk factors of SSIs and analyze health economics of DACC impregnated dressings for prevention of post-cesarean wound infections.

Conditions

Surgical Site Infection; Infection; Cesarean Section

Keywords

surgical site infection; dialkylcarbamoylchloride impregnated dressing; caesarean section; wound dehiscence

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with surgical site infection

  SSI determined according to Centers for Disease Control and Prevention (CDC) criteria

  within the first 14 days post surgery

Secondary Outcomes (19)

• Percentage of patients with SSI associated wound dehiscence

  within the first 8 weeks post surgery

• Length of the primary and any secondary hospitalization

  Day 0 (day of surgery/ the first day of readmission to hospital) until the date of discharge, up to 8 weeks post surgery

• Readmissions to hospital due to SSI following caesarean section

  within the first 8 weeks post surgery

• Percentage of patients with antibiotic treatment due to SSI following caesarean section

  within the first 8 weeks post surgery

• Surgeons experience

  Day 0 (day of surgery)

Other Outcomes (5)

• Cost of antibiotic treatment due to SSI

  Day 0 (the first day of antibiotic treatment) until the last day of treatment, up to 8 weeks post surgery

• Cost of hospital stay due to SSI

  Day 0 (day of SSI diagnosis/ the first day of hospital readmission due to SSI) until the end of treatment and discharge, up to 8 weeks post surgery

• Cost of nursing care due to SSI

  Day 0 (day of SSI diagnosis/ the first day of hospital readmission due to SSI) until the end of treatment and discharge, up to 8 weeks post surgery

Study Arms (2)

DACC impregnated dressing

EXPERIMENTAL

Patients undergoing elective or emergency caesarean section with DACC impregnated dressing Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden) placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively

Device: DACC impregnated dressing

Standard surgical dressing

ACTIVE COMPARATOR

Patients undergoing elective or emergency caesarean section with standard surgical dressing placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively

Device: Standard surgical dressing

Interventions

DACC impregnated dressing DEVICE

DACC impregnated dressing Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden) placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively

Also known as: Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden)

DACC impregnated dressing

Standard surgical dressing DEVICE

Standard surgical dressing placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively

Standard surgical dressing

Eligibility Criteria

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

You may qualify if:

• age ≥ 18 years
• undergoing elective or emergency caesarean section
• transverse skin incision
• low transverse uterine incision
• single and multiple pregnancy
• intravenous administration of 1g cefazolin 0-30 minutes prior to the start of surgery
• irrigation of the wound with octenidine prior to the subcutaneous tissue closure

You may not qualify if:

• patients age \<18 years
• patients physical or mental incapacity to give informed consent
• skin incision other than transverse
• uterine incision other than low transverse
• patients that did not receive routine prophylactic dose of antibiotics prior to the start of surgery
• patients without irrigation of the wound with octenidine prior to the subcutaneous tissue closure

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 03-242, Poland

Location

Related Publications (6)

• Falk P, Ivarsson ML. Effect of a DACC dressing on the growth properties and proliferation rate of cultured fibroblasts. J Wound Care. 2012 Jul;21(7):327-8, 330-2. doi: 10.12968/jowc.2012.21.7.327.

  PMID: 22886332 BACKGROUND

• Ljungh A, Yanagisawa N, Wadstrom T. Using the principle of hydrophobic interaction to bind and remove wound bacteria. J Wound Care. 2006 Apr;15(4):175-80. doi: 10.12968/jowc.2006.15.4.26901. No abstract available.

  PMID: 16620048 BACKGROUND

• Gentili V, Gianesini S, Balboni PG, Menegatti E, Rotola A, Zuolo M, Caselli E, Zamboni P, Di Luca D. Panbacterial real-time PCR to evaluate bacterial burden in chronic wounds treated with Cutimed Sorbact. Eur J Clin Microbiol Infect Dis. 2012 Jul;31(7):1523-9. doi: 10.1007/s10096-011-1473-x. Epub 2011 Nov 19.

  PMID: 22113306 BACKGROUND

• Derbyshire A. Innovative solutions to daily challenges. Br J Community Nurs. 2010 Sep;Suppl:S38, S40-5.

  PMID: 20852534 BACKGROUND

• Opoien HK, Valbo A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. doi: 10.1080/00016340701515225.

  PMID: 17712651 BACKGROUND

• Butcher, M. DACC antimicrobial technology: a new paradigm in bioburden management. JWC/BSN supplement:1-20, 2011.

  BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Infections

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paweł Stanirowski, MD

  Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Włodzimierz Sawicki, MD, PhD

  Chair and Department of Obstetrics and Gynecology, II Faculty of Medicine, Medical University of Warsaw

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

PL (1)