External Negative Pressure Dressing System vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.

NCT04434820 | Completed DMC FDA Device

• 1 other identifier: 642357
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is associated with increased cesarean section delivery rates and surgical site infections with associated increased post-operative morbidity, post-operative pain and length of hospital stay. Negative pressure wound therapy (NPWT) technology could be used as a prophylactic measure to reduce surgical site infections in obese women undergoing cesarean section by immediate postoperative application in clean-contaminated, closed surgical incisions.

Conditions

Wound Dehiscence

Keywords

wound dehiscence; obesity; negative pressure therapy

Outcome Measures

Primary Outcomes (1)

• incidence of wound dehiscence

  separation of the incision line prior to complete healing resulting in an open wound.

  till 30 days post operative

Secondary Outcomes (7)

• post operative pain

  till 30 days post operative

• length of hospital stay

  till 30 days post operative

• the need for re-admission

  till 30 days post operative

• further need for additional antibiotics

  till 30 days post operative

• peri-incision blistering

  till 30 days post operative

Study Arms (2)

standard dressing group

NO INTERVENTION

patients will receive sterile wound dressing of gauze and tape for 4 days.

External negative pressure dressing system group

ACTIVE COMPARATOR

patients will receive placement of a sterile dressing of gauze and occlusive adhesive over the closed incision. The dressing's tubing will then be attached to a compact, portable negative-pressure therapy unit (Yuwell 7E-A portable suction unit) that will deliver -80 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.

Device: External negative pressure dressing system (Yuwell 7E-A portable suction unit)

Interventions

External negative pressure dressing system (Yuwell 7E-A portable suction unit) DEVICE

A portable suction unit that will deliver 125 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.

External negative pressure dressing system group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 or older
• BMI: 30 or greater
• undergoing Cesarean section through a Pfannenstiel incision

You may not qualify if:

• Prolonged Rupture of membranes \>18 hours
• Intra amniotic infection
• Severe anemia
• Vasculopathies as in hypertension/pre-eclampsia, pregestational / gestational diabetes mellitus, smoking and substance abuse
• Prolonged steroids therapy as in SLE, ITP
• Intraoperative complications as bladder or bowel injury , placenta previa / accreta, difficult fetal extraction , ovarian cysts, pelvic abscess
• Intra-abdominal or subcutaneous drain

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

AinShams maternity hospital

Cairo, Al-Waili, 11658, Egypt

Location

Related Publications (8)

• Hyldig N, Vinter CA, Kruse M, Mogensen O, Bille C, Sorensen JA, Lamont RF, Wu C, Heidemann LN, Ibsen MH, Laursen JB, Ovesen PG, Rorbye C, Tanvig M, Joergensen JS. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. BJOG. 2019 Apr;126(5):628-635. doi: 10.1111/1471-0528.15413. Epub 2018 Sep 7.

  PMID: 30066454 BACKGROUND

• Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.

  PMID: 24056202 BACKGROUND

• Orth TA, Gerkovich MM, Heitmann E, Overcash J, Gibbs C, Parrish M. Cesarean Delivery with External Negative Pressure Dressing System: A Retrospective Cohort Study. Surg J (N Y). 2016 Jul 20;2(3):e59-e65. doi: 10.1055/s-0036-1585470. eCollection 2016 Jul.

  PMID: 28824992 BACKGROUND

• Scalise A, Tartaglione C, Bolletta E, Calamita R, Nicoletti G, Pierangeli M, Grassetti L, Di Benedetto G. The enhanced healing of a high-risk, clean, sutured surgical incision by prophylactic negative pressure wound therapy as delivered by Prevena Customizable: cosmetic and therapeutic results. Int Wound J. 2015 Apr;12(2):218-23. doi: 10.1111/iwj.12370. Epub 2014 Sep 19.

  PMID: 25234139 BACKGROUND

• Smid MC, Dotters-Katz SK, Grace M, Wright ST, Villers MS, Hardy-Fairbanks A, Stamilio DM. Prophylactic Negative Pressure Wound Therapy for Obese Women After Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Nov;130(5):969-978. doi: 10.1097/AOG.0000000000002259.

  PMID: 29016508 BACKGROUND

• Todd B. New CDC Guideline for the Prevention of Surgical Site Infection. Am J Nurs. 2017 Aug;117(8):17. doi: 10.1097/01.NAJ.0000521963.77728.c0.

  PMID: 28749874 BACKGROUND

• Wells CI, Ratnayake CBB, Perrin J, Pandanaboyana S. Prophylactic Negative Pressure Wound Therapy in Closed Abdominal Incisions: A Meta-analysis of Randomised Controlled Trials. World J Surg. 2019 Nov;43(11):2779-2788. doi: 10.1007/s00268-019-05116-6.

  PMID: 31396673 BACKGROUND

• Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.

  PMID: 28255256 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dalia M Mokhtar, MBBCh

  resident of obstetrics and gynecology

  PRINCIPAL INVESTIGATOR

• Marwan O Elkady, MD

  Lecturer of obstetrics and gynecology

  STUDY DIRECTOR

• Mohammed S El Sokkary, MD

  Professor of obstetrics and gynecology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of obstetrics and gynecology

Model Details: Basic information included age, ethnicity, weight, height, body mass index (BMI). Full obstetric, medical and surgical history. Informed written consent will be obtained Patients will receive standard preoperative antibiotic prophylaxis Wound dressing will be applied in a sterile fashion after primary closure of the Pfannenstiel incision closure by interrupted PROLENE Polypropylene Sutures The intervention group: placement of a sterile multilayer dressing (wicking fabric, reticulated foam, and occlusive adhesive). The dressing's tubing will then be attached to a (Yuwell 7E-A portable suction unit) that will deliver 125 mm Hg of continuous pressure to the dressing for 4 days. The comparison group: traditional sterile wound dressing of gauze and tape for 4 days. Post-operative data including: type of dressing used, postoperative hemoglobin, degree of pain, length of hospital stay, readmission for surgical site infection and the type of the surgical site infection.

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 17, 2020
• Study Start: August 3, 2020
• Primary Completion: February 3, 2021
• Study Completion: February 4, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after completing the study and henceforth .
• Access Criteria: everyone can review the IPD on this site for any type of analysis they desire .

Locations

EG (1)