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

The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes: a Double-Blind, Randomized Controlled Trial

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

Participants were randomized into two groups: the intervention group received an amniotic membrane application over the cesarean incision site, while the control group underwent cesarean delivery without membrane application. Outcomes were assessed at predefined postoperative intervals, focusing on wound healing, pain levels, and cosmetic satisfaction.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Other: Amniotic Membrane Application

Detailed Description

This randomized, double-blind, controlled trial investigates the effectiveness of amniotic membrane application in reducing post-cesarean complications, including surgical site infections, wound dehiscence, and scar formation. The trial also assesses its impact on pain management and cosmetic outcomes in women aged 18-40 undergoing their first cesarean section. The study was conducted between May 2022 and May 2023 at Van Regional Training and Research Hospital.

The amniotic membrane, the innermost layer of the placenta, has regenerative, anti-inflammatory, and antimicrobial properties. Its application during cesarean delivery may offer a cost-effective and autologous intervention to enhance surgical outcomes and patient satisfaction.

Objectives:

Primary Objectives:

1. Evaluate whether the amniotic membrane reduces surgical complications, including infections, hematoma, and wound dehiscence.
2. Investigate its role in preventing hypertrophic scars and keloids.

Secondary Objectives:

1. Assess the effect of amniotic membrane application on postoperative pain levels using the Visual Analog Scale (VAS).
2. Measure patient satisfaction with cosmetic results using the Modified Hollander Wound Evaluation Scale.

Methodology:

A total of 372 participants were enrolled and randomized into two groups (1:1 ratio) using block randomization to ensure balanced allocation. The intervention group received an amniotic membrane, harvested intraoperatively from the placenta and applied directly to the cesarean incision site before closure. The control group underwent cesarean delivery without membrane application. Both groups were blinded to their assignments, and standard postoperative wound care was provided.

Participants were evaluated at multiple predefined postoperative time points (days 1, 2, 7, 40, and 6 months) for surgical site infections, wound dehiscence, scar/keloid formation, pain levels, and cosmetic satisfaction.

Significance:

This study provides evidence supporting the use of autologous amniotic membranes in obstetrics, potentially establishing a low-cost, accessible method to improve surgical outcomes and patient quality of life. If successful, these findings may have broader implications for other surgical fields and high-risk patient populations.

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65090
    • Van Regional Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amniotic Membrane Group; 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; 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.
No Intervention: Control Group (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain (VAS Score)	Description: Pain scores measured using the Visual Analog Scale (VAS). Scale: 0 to 10 (0 = no pain, 10 = worst pain).	Time Frame: Postoperative days 1 and 2.
Cosmetic Satisfaction	Description: Patient-reported satisfaction with the cosmetic appearance of the incision site, measured using the Modified Hollander Wound Evaluation Scale. Scale: 0 to 6 (higher scores indicate better cosmetic outcomes).	Time Frame: At 40 days post-surgery.

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): May 20, 2023
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative Pain; Surgical Site Infection; Wound Healing; Cesarean Section; Maternal Health; Regenerative Medicine; Amniotic Membrane; Hypertrophic Scarring; Keloid Formation; Cosmetic Outcomes
• Other Study ID Numbers: 2022/22-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Plan to Share IPD: No Plan Description: Individual participant data will not be shared due to institutional data-sharing policies and privacy concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No