The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes

NCT06770946 | Completed

• 1 other identifier: 2022/22-05
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates the effectiveness of amniotic membrane application during cesarean delivery in reducing post-surgical complications and improving wound healing and cosmetic outcomes in women aged 18-40 undergoing their first cesarean section. The primary questions this study aims to answer are:

1. 1.Compared to standard care, Does the amniotic membrane reduce surgical site infections and wound dehiscence?
2. 2.Does the amniotic membrane improve patient satisfaction with cosmetic outcomes?

Conditions

Cesarean Section

Keywords

Amniotic Membrane; Cesarean Section; Wound Healing; Surgical Site Infection; Postoperative Pain; Hypertrophic Scarring; Keloid Formation; Cosmetic Outcomes; Regenerative Medicine; Maternal Health

Outcome Measures

Primary Outcomes (3)

• Surgical Site Infection (SSI)

  Description: The presence of surgical site infections diagnosed based on erythema, induration, tenderness, and purulent discharge. Scale: Binary (Yes/No)

  Time Frame: Within 7 days post-surgery.

• Wound Dehiscence

  Description: The occurrence of wound dehiscence defined as a wound gap of less than 1 cm in depth. Scale: Binary (Yes/No).

  Time Frame: Within 7 days post-surgery.

• Scar/Keloid Formation

  Description: The presence of hypertrophic scars or keloids assessed visually. Scale: Binary (Yes/No).

  Time Frame: At 40 days and 6 months post-surgery.

Secondary Outcomes (2)

• Postoperative Pain (VAS Score)

  Time Frame: Postoperative days 1 and 2.

• Cosmetic Satisfaction

  Time Frame: At 40 days post-surgery.

Study Arms (2)

Amniotic Membrane Group

EXPERIMENTAL

Participants in this arm received an amniotic membrane application directly to the cesarean incision site during surgery. The membrane was harvested intraoperatively from the placenta and placed over the incision area before closure. It was removed 24 hours postoperatively, followed by standard postoperative wound care.

Other: Amniotic Membrane Application

Control Group (No Intervention)

NO INTERVENTION

Participants in this arm underwent standard cesarean delivery without the application of an amniotic membrane. Standard postoperative wound care was provided without any additional intervention.

Interventions

Amniotic Membrane Application OTHER

Amniotic Membrane Application: This intervention involves the application of an amniotic membrane harvested intraoperatively from the fetal side of the placenta during cesarean delivery. The membrane is placed directly on the incision site before surgical closure to promote wound healing and reduce complications such as infection, dehiscence, and scarring. The membrane is removed 24 hours postoperatively, and standard wound care is continued thereafter.

Amniotic Membrane Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study is limited to individuals with a biological sex of female, as it involves cesarean delivery outcomes
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18-40 years. Undergoing their first cesarean section. Term pregnancies (≥37 weeks of gestation). Elective cesarean delivery performed under spinal anesthesia. Use of the Pfannenstiel incision method. Willing and able to provide written informed consent.

You may not qualify if:

• History of previous abdominal surgeries. Presence of chronic conditions such as diabetes mellitus, hypertension, or vascular diseases.
• Pulmonary conditions or collagen tissue disorders affecting wound healing. Signs of infection during delivery. Use of medications or therapies that impair wound healing (e.g., corticosteroids, immunosuppressants).
• Known hypersensitivity to materials or methods used in the study

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Regional Training and Research Hospital

Van, Van, 65090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical Wound Infection; Pain, Postoperative; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Cicatrix; Fibrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: No additional parties are masked beyond the Participant and Outcomes Assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: This study uses a parallel-group design, where participants are randomly assigned to one of two groups: Intervention Group: Participants receive an amniotic membrane application over the cesarean incision site. Control Group: Participants undergo cesarean delivery without amniotic membrane application. Both groups were followed simultaneously to evaluate postoperative outcomes, including surgical site infection, wound healing, pain, and cosmetic satisfaction. Randomization was performed using a block randomization method to ensure balanced group sizes. This design ensures a robust comparison between the intervention and control groups under similar conditions.

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 13, 2025
• Study Start: May 20, 2022
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)