Van Regional Training and Research Hospital
Van, 65090, Turkey (Türkiye)
NCT Number: NCT06770946
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.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Van, 65090, Turkey (Türkiye)
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:
Secondary Objectives:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: Time Frame: Within 7 days post-surgery.
Description: The presence of surgical site infections diagnosed based on erythema, induration, tenderness, and purulent discharge.
Scale: Binary (Yes/No)
Time frame: Time Frame: Within 7 days post-surgery.
Description: The occurrence of wound dehiscence defined as a wound gap of less than 1 cm in depth.
Scale: Binary (Yes/No).
Time frame: Time Frame: At 40 days and 6 months post-surgery.
Description: The presence of hypertrophic scars or keloids assessed visually. Scale: Binary (Yes/No).
Time frame: Time Frame: Postoperative days 1 and 2.
Description: Pain scores measured using the Visual Analog Scale (VAS). Scale: 0 to 10 (0 = no pain, 10 = worst pain).
Time frame: Time Frame: At 40 days post-surgery.
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).
Yuzuncu Yil University
Other
The Effect of Amniotic Membrane Application on Post-Cesarean Wound Healing and Cosmetic Outcomes: a Double-Blind, Randomized Controlled Trial
Acronym: Amniotic Membr
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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