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

NCT ID: NCT02168023

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 543 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

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.

Detailed Description

This is a single-blinded randomized controlled trial performed at the Department of Obstetrics and Gynecology of Medical University of Warsaw. The study will involve 518 patients undergoing caesarean section who after giving their informed consent will be randomly divided into two groups: study (n=259) and control group (n=259). The study group will receive DACC impregnated dressing - Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden) and the control group will receive standard surgical dressing.

In all participants transverse skin incision and low transverse uterine incision will be performed during caesarean section procedure.

All participants will receive prophylactic dose of antibiotics prior to the start of surgery (1g cefazolin intravenously 0-30 minutes before surgery) and wound irrigation with octenidine prior to the subcutaneous tissue closure.

For fascial incision, subcutaneous tissue and skin incision closure continuous antibacterial braided absorbable suture, single monofilament absorbable suture and subcuticular continuous monofilament non-absorbable suture will be used, respectively.

Dressing will be left in place for the first 48 hours post caesarean section unless clinical reason exists to replace it. After the first 48 hours postoperatively all of the dressings will be removed and first wound evaluation will be performed. On post-operative day 3 patients will be discharged and indicated to revisit on post-operative day 7 to remove the skin suture. During this follow-up visit second wound review will be performed for any signs of infection. Third, and final wound assessment will take place on post-operative day 14.

To analyze overall treatment costs patients with SSI will be followed up until the end of treatment, up to 8 weeks post surgery.

Conditions

Surgical Site Infection; Infection; Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

DACC impregnated dressing

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

Group Type: EXPERIMENTAL

DACC impregnated dressing

Intervention Type: 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

Standard surgical dressing

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

Group Type: ACTIVE_COMPARATOR

Standard surgical dressing

Intervention Type: DEVICE

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

Interventions

DACC impregnated dressing

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

Intervention Type: DEVICE

Standard surgical dressing

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

Intervention Type: DEVICE

Other Intervention Names

Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Paweł Stanirowski

Doctor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paweł Stanirowski, MD

Role: PRINCIPAL_INVESTIGATOR

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

Włodzimierz Sawicki, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 22886332 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16620048 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22113306 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 20852534 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17712651 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

KB/127/2014

Identifier Type: OTHER

Identifier Source: secondary_id

DACC-1

Identifier Type: -

Identifier Source: org_study_id