Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04434820
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2020-06-14
Brief Title:
External Negative Pressure Dressing System vs Traditional Wound Dressing for Cesarean Section Incision in Obese Women
Sponsor:
Ain Shams Maternity Hospital
Organization:
Ain Shams Maternity Hospital
Study Overview
Official Title:
External Negative Pressure Dressing System ENPDS vs Traditional Wound Dressing for Cesarean Section Incision in Obese Women
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Obesity defined as body mass index BMI calculated as weight kg height m 2 of 30 or greater is a common medical comorbidity of pregnancy affecting one third of reproductive-aged women Maternal obesity is also a well-recognized risk factor for dysfunctional labor and cesarean delivery with a cesarean section rate of 33 in obese women with BMI of 30 or greater and 43 in women with BMIs of 40 or greater
Obesity is an independent risk factor for post-operative surgical site infection The risk of post-cesarean surgical site infection has been shown to double for every 5 unit increase in body mass index BMI above 30 kgm occurring in about 10 of obese women undergoing caesarean section despite prophylactic strategies eg antibiotics
This can be explained partly by a decreased blood flow in adipose tissue and an obesity-associated inflammation causing vascular dysfunction which results in a local hypoxic response Hypoxia impairs oxidative bacterial killing and leads to an increased risk of surgical site infection
Wound healing is a sequence of physiologic events that include inflammation epithelialization fibroplasia and maturation Failure of wound healing at the surgical site can lead to seroma hematoma wound dehiscence incisional hernia and surgical site infection
Surgical site infection SSI according to The Centers for Disease Control and Prevention is as an infection occurring within 30 days from the operative procedure in the part of the body where the surgery took place where there is purulent drainage from incision isolated organisms from the incision dehiscence or deliberate opening by the surgeon when the patient has at least one sign or symptom of clinical infection localized pain edema erythema warmth and fever greater than 38 c unless culture of incision is negative or there is an abscess or other evidence of infection is found during examination of incision reoperation or pathologic or radiologic exam
SSIs is divided into incisional SSI and organspace SSI Incisional SSI is further divided into superficial and deep incisional SSI Superficial Incisional Surgical Site Infection involves skin or subcutaneous tissue cellulitis seroma hematoma wound healing disruption or dehiscence Deep Incisional Surgical Site Infection involves deep soft tissues such as fascia or muscle within incision OrganSpace Surgical Site Infection involves any part of the anatomy other than the incision SSI is associated with a maternal mortality rate of up to 3
Wound complication even if not accompanied by an infection is a significant cause of postoperative morbidity following cesarean delivery In addition to the increased cost of care there is the inconvenience of therapy increased postoperative pain and convalescence as well as difficulty with activities of daily living
It is logical to employ novel risk reducing approaches including negative pressure wound therapy at the time of surgery that may prevent wound complications and to ensure that there is a demonstrable benefit to their use for wound complication prophylaxis
Negative pressure wound therapy NPWT also known as a vacuum assisted closure VAC involves the controlled application of sub-atmospheric pressure to the local wound environment using a sealed wound dressing connected to a vacuum to promote healing by primary intention by reducing the risk of hematoma seroma due to improved lymphatic drainage and reduces the risk of wound dehiscence by decreasing the lateral and shear stress on sutures and decreasing bacterial load and wound fluids and by increasing blood flow oxygenation angiogenesis and epithelialization
Obesity is an independent risk factor for post-operative surgical site infection The risk of post-cesarean surgical site infection has been shown to double for every 5 unit increase in body mass index BMI above 30 kgm occurring in about 10 of obese women undergoing caesarean section despite prophylactic strategies eg antibiotics
This can be explained partly by a decreased blood flow in adipose tissue and an obesity-associated inflammation causing vascular dysfunction which results in a local hypoxic response Hypoxia impairs oxidative bacterial killing and leads to an increased risk of surgical site infection
Wound healing is a sequence of physiologic events that include inflammation epithelialization fibroplasia and maturation Failure of wound healing at the surgical site can lead to seroma hematoma wound dehiscence incisional hernia and surgical site infection
Surgical site infection SSI according to The Centers for Disease Control and Prevention is as an infection occurring within 30 days from the operative procedure in the part of the body where the surgery took place where there is purulent drainage from incision isolated organisms from the incision dehiscence or deliberate opening by the surgeon when the patient has at least one sign or symptom of clinical infection localized pain edema erythema warmth and fever greater than 38 c unless culture of incision is negative or there is an abscess or other evidence of infection is found during examination of incision reoperation or pathologic or radiologic exam
SSIs is divided into incisional SSI and organspace SSI Incisional SSI is further divided into superficial and deep incisional SSI Superficial Incisional Surgical Site Infection involves skin or subcutaneous tissue cellulitis seroma hematoma wound healing disruption or dehiscence Deep Incisional Surgical Site Infection involves deep soft tissues such as fascia or muscle within incision OrganSpace Surgical Site Infection involves any part of the anatomy other than the incision SSI is associated with a maternal mortality rate of up to 3
Wound complication even if not accompanied by an infection is a significant cause of postoperative morbidity following cesarean delivery In addition to the increased cost of care there is the inconvenience of therapy increased postoperative pain and convalescence as well as difficulty with activities of daily living
It is logical to employ novel risk reducing approaches including negative pressure wound therapy at the time of surgery that may prevent wound complications and to ensure that there is a demonstrable benefit to their use for wound complication prophylaxis
Negative pressure wound therapy NPWT also known as a vacuum assisted closure VAC involves the controlled application of sub-atmospheric pressure to the local wound environment using a sealed wound dressing connected to a vacuum to promote healing by primary intention by reducing the risk of hematoma seroma due to improved lymphatic drainage and reduces the risk of wound dehiscence by decreasing the lateral and shear stress on sutures and decreasing bacterial load and wound fluids and by increasing blood flow oxygenation angiogenesis and epithelialization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None