Mepilex Ag Dressing for Postpartum Infection

(MEPIDEL Trial)

Overseen By Anna Weinstein

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must not be taking: Chemotherapy, Steroids

Disqualifiers: Silver allergy, Skin infection, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate postoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special silver-containing foam dressing, called Mepilex Ag, can prevent infections after a cesarean delivery more effectively than regular dressings. Participants will receive either the Mepilex Ag dressing or a standard one following their routine cesarean surgery. Researchers will monitor for any signs of infection. The trial suits individuals having a planned cesarean delivery, who can speak English or Spanish, and have a phone for follow-up.

As an unphased trial, it provides participants the opportunity to contribute to important research that could enhance post-surgical care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Mepilex Ag dressing is safe for postpartum use?

Research has shown that dressings with silver, such as Mepilex Ag, might help prevent infections in surgical wounds. Studies have found these dressings are easy for patients to use and can lower the chance of infections at the surgery site. This suggests they might be safer or cause fewer issues compared to some other options.

In past studies, patients did not report serious side effects from using silver dressings. These dressings have a strong ability to fight germs, keeping bacteria away from the wound. Overall, silver dressings like Mepilex Ag have been used safely in other surgeries and might help reduce infection without causing major problems for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mepilex Ag dressing for postpartum infections because it incorporates silver, an antimicrobial agent, directly into the dressing. Unlike standard surgical dressings, which typically use materials like Telfa pads and gauze, Mepilex Ag actively combats bacteria at the wound site, potentially reducing infection risk. This innovative approach could offer enhanced protection and faster healing for new mothers recovering from cesarean deliveries.

What evidence suggests that Mepilex Ag is effective for preventing postpartum infection?

This trial will compare the effectiveness of Mepilex Ag, a silver-impregnated antimicrobial foam dressing, with standard surgical dressings in preventing postpartum infections. Research has shown that dressings with silver, like Mepilex Ag, might help prevent wound infections. These dressings have reduced post-surgery ulcers, a type of wound problem. Silver effectively kills or inhibits bacterial growth, acting faster than some other dressings in lab settings. However, not all studies have found significant differences in wound healing between silver dressings and regular ones. Overall, Mepilex Ag's potential to prevent infections is supported by its strong antibacterial properties. ^{1 2 4 5 6}

Who Is on the Research Team?

Georgios Doulaveris

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for patients undergoing cesarean delivery. It's designed to see if a special foam dressing with silver (Mepilex Ag) can prevent infections better than standard dressings after surgery.

Inclusion Criteria

Undergoing non-emergent cesarean delivery at our institution

I am 18 years old or older.

I can give my consent in English or Spanish.

Exclusion Criteria

Known hypersensitivity or allergy to silver, Aquacel Ag, or adhesive materials

I am not in any other trials that could affect wound healing or surgery results.

Inability to complete follow-up due to anticipated relocation, incarceration, or other logistical barrier

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cesarean delivery and receive either a silver-impregnated antimicrobial foam dressing or a standard dressing

Immediate postoperative period

1 visit (in-person)

Follow-up

Participants are monitored for wound complications and signs of infection during the postpartum period

30 days

Follow-up telephone assessment and review of electronic health records

Patient Satisfaction Assessment

Patient satisfaction with the postoperative dressing is assessed using the Adapted Wound Dressing Satisfaction Questionnaire

Up to 7 days after cesarean delivery

What Are the Treatments Tested in This Trial?

Interventions

• Mepilex Ag

Trial Overview The study compares the effectiveness of Mepilex Ag, a silver-containing antimicrobial foam dressing, against standard surgical dressings in preventing post-cesarean wound infections. Participants are randomly assigned to one of the two dressing types.

How Is the Trial Designed?

Group I: Mepilex Ag Dressing Experimental Treatment 1 Intervention

Participants in this arm will receive a silver-impregnated antimicrobial foam dressing (Mepilex Ag) applied to the surgical incision following cesarean delivery.

Group II: Standard Surgical Dressing (Telfa non-adhesive pad, gauze, Primapore adhesive bandage) Active Control 1 Intervention

Participants in this arm will receive the standard postoperative surgical dressing currently used at our institution following cesarean delivery. This dressing consists of a Telfa non-adhesive pad placed over the incision, covered with gauze, and secured with a Primapore adhesive bandage.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03136159

The Role of Antimicrobial Foam Dressing in Prevention of ... Silver-containing dressings may prevent wound infections. The purpose of the current study is to determine if the use of a silver-impregnated dressing decreases ...

2. withpower.com withpower.com/trial/phase-surgical-wound-infection-8-2025-b565f

Mepilex Ag Dressing for Postpartum Infection ... It's designed to see if a special foam dressing with silver (Mepilex Ag) can prevent infections better than standard dressings after surgery. Inclusion Criteria.

3. cda-amc.ca cda-amc.ca/sites/default/files/pdf/htis/2017/RB1109%20Mepilex%20Ag%20Final.pdf

The Use of Silver Impregnated Dressings to Prevent or ... Another study14 reported a decrease in post-operative ulcers after the use of silver-impregnated dressings, but they did not report on ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10516230/

Antimicrobial Activity of Silver-Containing Surgical ... A more rapid antimicrobial activity was observed for the ISEB SCD compared with other dressings tested within this in vitro model.

5. researchgate.net researchgate.net/publication/333089995_Silver-containing_foam_dressings_with_Safetac_a_review_of_the_scientific_and_clinical_data

Silver-containing foam dressings with Safetac: a review of ... Conclusion: Moderate quality evidence indicates that there is no significant difference in wound healing between silver-containing foam dressing ...

6. molnlycke.us molnlycke.us/products-solutions/mepilex-border-post-op-ag/

Mepilex Border Post-Op Ag all-in-one silver post-op dressing Helps reduce surgical site infections · Support patient mobility · Reduce dressing related costs · Provides a broad and sustained antimicrobial effect · minimizes ...