Wound DehiscenceNCT04434820
External Negative Pressure Dressing System vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.
A study testing External negative pressure dressing system (Yuwell 7E-A portable suction unit) in people with Wound Dehiscence, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Dehiscence
- What is being tested?
- External negative pressure dressing system (Yuwell 7E-A portable suction unit)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2020to 4 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 or older
- BMI: 30 or greater
- undergoing Cesarean section through a Pfannenstiel incision
Who cannot join
- Prolonged Rupture of membranes >18 hours
- Intra amniotic infection
- Severe anemia
- Vasculopathies as in hypertension/pre-eclampsia, pregestational / gestational diabetes mellitus, smoking and substance abuse
- Prolonged steroids therapy as in SLE, ITP
- Intraoperative complications as bladder or bowel injury , placenta previa / accreta, difficult fetal extraction , ovarian cysts, pelvic abscess
- Intra-abdominal or subcutaneous drain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Negative Pressure Dressing System (ENPDS) vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.
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.
Read the 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 kg/m , occurring in about 10% of obese women undergoing caesarean section despite prophylactic strategies (e.g. 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 organ/space 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. Organ/Space 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.
- Conditions
- Wound Dehiscence
- Being tested
- External negative pressure dressing system (Yuwell 7E-A portable suction unit)
- Keywords
- wound dehiscence, obesity, negative pressure therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External negative pressure dressing system (Yuwell 7E-A portable suction unit)Device
A portable suction unit that will deliver 125 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| standard dressing group | No intervention | patients will receive sterile wound dressing of gauze and tape for 4 days. |
| External negative pressure dressing system group | Active comparator | patients will receive placement of a sterile dressing of gauze and occlusive adhesive over the closed incision. The dressing's tubing will then be attached to a compact, portable negative-pressure therapy unit (Yuwell 7E-A portable suction unit) that will deliver -80 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days. Receives: Device: External negative pressure dressing system (Yuwell 7E-A portable suction unit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of wound dehiscence
separation of the incision line prior to complete healing resulting in an open wound.
Measured: till 30 days post operative
Secondary outcomes (7)
post operative pain
post-operative pain assessed by Wong-Baker Faces pain rating scale,from 0=no pain to 10=maximal pain
Measured: till 30 days post operative
length of hospital stay
days spent admitted to the hospital
Measured: till 30 days post operative
the need for re-admission
if the patient encountered surgical site infection requiring re admission to the hospital
Measured: till 30 days post operative
further need for additional antibiotics
if the surgical site infection required additional post operative antibiotics
Measured: till 30 days post operative
peri-incision blistering
if any skin blistering occurs under the occlusive adhesive layer
Measured: till 30 days post operative
patient mobility
if attachment to a negative pressure pump affects patients mobility
Measured: 4 days
surgical site infection
as defined by the CDC
Measured: 30 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start3 Aug 2020
- Primary completion3 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Wound DehiscenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Basic information included age, ethnicity, weight, height, body mass index (BMI). Full obstetric, medical and surgical history. Informed written consent will be obtained Patients will receive standard preoperative antibiotic prophylaxis Wound dressing will be applied in a sterile fashion after primary closure of the Pfannenstiel incision closure by interrupted PROLENE Polypropylene Sutures The intervention group: placement of a sterile multilayer dressing (wicking fabric, reticulated foam, and occlusive adhesive). The dressing's tubing will then be attached to a (Yuwell 7E-A portable suction unit) that will deliver 125 mm Hg of continuous pressure to the dressing for 4 days. The comparison group: traditional sterile wound dressing of gauze and tape for 4 days. Post-operative data including: type of dressing used, postoperative hemoglobin, degree of pain, length of hospital stay, readmission for surgical site infection and the type of the surgical site infection.
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Magdy Mokhtar, Ain Shams Maternity Hospital
- Investigators
- Dalia M Mokhtar, MBBCh, Principal investigator, resident of obstetrics and gynecologyMarwan O Elkady, MD, Study director, Lecturer of obstetrics and gynecologyMohammed S El Sokkary, MD, Study chair, Professor of obstetrics and gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434820
- Sponsor's protocol ID
- 642357
- Status last verified
- Feb 2021
- First submitted
- 14 Jun 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: patient's age ,ethnicity,gravidity,parity,gestational age ,previous cesarean section, previous surgeries,weight, height,BMI,pre/post operative haemoglobin,degree of post operative pain,incidence and type of surgical site infection,length of hospital stay, need for re-admission,need for additional antibiotics
Publications
Hyldig N, Vinter CA, Kruse M, Mogensen O, Bille C, Sorensen JA, Lamont RF, Wu C, Heidemann LN, Ibsen MH, Laursen JB, Ovesen PG, Rorbye C, Tanvig M, Joergensen JS. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. BJOG. 2019 Apr;126(5):628-635. doi: 10.1111/1471-0528.15413. Epub 2018 Sep 7.
PubMed 30066454Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.
PubMed 24056202Orth TA, Gerkovich MM, Heitmann E, Overcash J, Gibbs C, Parrish M. Cesarean Delivery with External Negative Pressure Dressing System: A Retrospective Cohort Study. Surg J (N Y). 2016 Jul 20;2(3):e59-e65. doi: 10.1055/s-0036-1585470. eCollection 2016 Jul.
PubMed 28824992Scalise A, Tartaglione C, Bolletta E, Calamita R, Nicoletti G, Pierangeli M, Grassetti L, Di Benedetto G. The enhanced healing of a high-risk, clean, sutured surgical incision by prophylactic negative pressure wound therapy as delivered by Prevena Customizable: cosmetic and therapeutic results. Int Wound J. 2015 Apr;12(2):218-23. doi: 10.1111/iwj.12370. Epub 2014 Sep 19.
PubMed 25234139Smid MC, Dotters-Katz SK, Grace M, Wright ST, Villers MS, Hardy-Fairbanks A, Stamilio DM. Prophylactic Negative Pressure Wound Therapy for Obese Women After Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Nov;130(5):969-978. doi: 10.1097/AOG.0000000000002259.
PubMed 29016508Todd B. New CDC Guideline for the Prevention of Surgical Site Infection. Am J Nurs. 2017 Aug;117(8):17. doi: 10.1097/01.NAJ.0000521963.77728.c0.
PubMed 28749874Wells CI, Ratnayake CBB, Perrin J, Pandanaboyana S. Prophylactic Negative Pressure Wound Therapy in Closed Abdominal Incisions: A Meta-analysis of Randomised Controlled Trials. World J Surg. 2019 Nov;43(11):2779-2788. doi: 10.1007/s00268-019-05116-6.
PubMed 31396673Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.
PubMed 28255256
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Negative Pressure Dressing System (ENPDS) vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.
- ClinicalTrials.gov ID
- NCT04434820
- Acronym / sponsor ID
- 642357
- Conditions
- Wound Dehiscence
- Keywords
- wound dehiscence, obesity, negative pressure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 kg/m , occurring in about 10% of obese women undergoing caesarean section despite prophylactic strategies (e.g. 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 organ/space 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. Organ/Space 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Basic information included age, ethnicity, weight, height, body mass index (BMI). Full obstetric, medical and surgical history. Informed written consent will be obtained Patients will receive standard preoperative antibiotic prophylaxis Wound dressing will be applied in a sterile fashion after primary closure of the Pfannenstiel incision closure by interrupted PROLENE Polypropylene Sutures The intervention group: placement of a sterile multilayer dressing (wicking fabric, reticulated foam, and occlusive adhesive). The dressing's tubing will then be attached to a (Yuwell 7E-A portable suction unit) that will deliver 125 mm Hg of continuous pressure to the dressing for 4 days. The comparison group: traditional sterile wound dressing of gauze and tape for 4 days. Post-operative data including: type of dressing used, postoperative hemoglobin, degree of pain, length of hospital stay, readmission for surgical site infection and the type of the surgical site infection.
| Arm | Type | Receives |
|---|---|---|
| standard dressing group | No intervention | –patients will receive sterile wound dressing of gauze and tape for 4 days. |
| External negative pressure dressing system group | Active comparator | Device: External negative pressure dressing system (Yuwell 7E-A portable suction unit)patients will receive placement of a sterile dressing of gauze and occlusive adhesive over the closed incision. The dressing's tubing will then be attached to a compact, portable negative-pressure therapy unit (Yuwell 7E-A portable suction unit) that will deliver -80 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 or older
- BMI: 30 or greater
- undergoing Cesarean section through a Pfannenstiel incision
Key exclusion criteria (7 listed)
- Prolonged Rupture of membranes >18 hours
- Intra amniotic infection
- Severe anemia
- Vasculopathies as in hypertension/pre-eclampsia, pregestational / gestational diabetes mellitus, smoking and substance abuse
- Prolonged steroids therapy as in SLE, ITP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External negative pressure dressing system (Yuwell 7E-A portable suction unit)A portable suction unit that will deliver 125 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days. | Device | External negative pressure dressing system group |
Primary outcome
incidence of wound dehiscence
Time frame: till 30 days post operative
separation of the incision line prior to complete healing resulting in an open wound.
7 secondary outcomes
post operative pain
Time frame: till 30 days post operative
length of hospital stay
Time frame: till 30 days post operative
the need for re-admission
Time frame: till 30 days post operative
further need for additional antibiotics
Time frame: till 30 days post operative
peri-incision blistering
Time frame: till 30 days post operative
patient mobility
Time frame: 4 days
surgical site infection
Time frame: 30 days post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 30066454Hyldig N, Vinter CA, Kruse M, Mogensen O, Bille C, Sorensen JA, Lamont RF, Wu C, Heidemann LN, Ibsen MH, Laursen JB, Ovesen PG, Rorbye C, Tanvig M, Joergensen JS. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. BJOG. 2019 Apr;126(5):628-635. doi: 10.1111/1471-0528.15413. Epub 2018 Sep 7.
- Background: PubMed 24056202Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.
- Background: PubMed 28824992Orth TA, Gerkovich MM, Heitmann E, Overcash J, Gibbs C, Parrish M. Cesarean Delivery with External Negative Pressure Dressing System: A Retrospective Cohort Study. Surg J (N Y). 2016 Jul 20;2(3):e59-e65. doi: 10.1055/s-0036-1585470. eCollection 2016 Jul.
- Background: PubMed 25234139Scalise A, Tartaglione C, Bolletta E, Calamita R, Nicoletti G, Pierangeli M, Grassetti L, Di Benedetto G. The enhanced healing of a high-risk, clean, sutured surgical incision by prophylactic negative pressure wound therapy as delivered by Prevena Customizable: cosmetic and therapeutic results. Int Wound J. 2015 Apr;12(2):218-23. doi: 10.1111/iwj.12370. Epub 2014 Sep 19.
- Background: PubMed 29016508Smid MC, Dotters-Katz SK, Grace M, Wright ST, Villers MS, Hardy-Fairbanks A, Stamilio DM. Prophylactic Negative Pressure Wound Therapy for Obese Women After Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Nov;130(5):969-978. doi: 10.1097/AOG.0000000000002259.
- Background: PubMed 28749874Todd B. New CDC Guideline for the Prevention of Surgical Site Infection. Am J Nurs. 2017 Aug;117(8):17. doi: 10.1097/01.NAJ.0000521963.77728.c0.
- Background: PubMed 31396673Wells CI, Ratnayake CBB, Perrin J, Pandanaboyana S. Prophylactic Negative Pressure Wound Therapy in Closed Abdominal Incisions: A Meta-analysis of Randomised Controlled Trials. World J Surg. 2019 Nov;43(11):2779-2788. doi: 10.1007/s00268-019-05116-6.
- Background: PubMed 28255256Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.
- Individual participant dataSharing planned: Yes. patient's age ,ethnicity,gravidity,parity,gestational age ,previous cesarean section, previous surgeries,weight, height,BMI,pre/post operative haemoglobin,degree of post operative pain,incidence and type of surgical site infection,length of hospital stay, need for re-admission,need for additional antibiotics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia M Mokhtar, MBBCh principal investigator
resident of obstetrics and gynecology
Marwan O Elkady, MD study director
Lecturer of obstetrics and gynecology
Mohammed S El Sokkary, MD study chair
Professor of obstetrics and gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External negative pressure dressing system (Yuwell 7E-A portable suction unit) in people with Wound Dehiscence, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of wound dehiscence (time frame: till 30 days post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434820, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.