Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial

Objective To evaluate the reduction of surgical site infections by prophylactic incisional negative pressure wound therapy compared with standard postoperative dressings in obese women giving birth by caesarean section. Design Multicentre randomised controlled trial. Setting Five hospitals in Denmar...

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Veröffentlicht in:BJOG : an international journal of obstetrics and gynaecology 2019-04, Vol.126 (5), p.628-635
Hauptverfasser: 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
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container_issue 5
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container_title BJOG : an international journal of obstetrics and gynaecology
container_volume 126
creator 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
description Objective To evaluate the reduction of surgical site infections by prophylactic incisional negative pressure wound therapy compared with standard postoperative dressings in obese women giving birth by caesarean section. Design Multicentre randomised controlled trial. Setting Five hospitals in Denmark. Population Obese women (prepregnancy body mass index (BMI) ≥30 kg/m2) undergoing elective or emergency caesarean section. Method The participants were randomly assigned to incisional negative pressure wound therapy or a standard dressing after caesarean section and analysed by intention‐to‐treat. Blinding was not possible due to the nature of the intervention. Main outcome measures The primary outcome was surgical site infection requiring antibiotic treatment within the first 30 days after surgery. Secondary outcomes included wound exudate, dehiscence and health‐related quality of life. Results Incisional negative pressure wound therapy was applied to 432 women and 444 women had a standard dressing. Demographics were similar between groups. Surgical site infection occurred in 20 (4.6%) women treated with incisional negative pressure wound therapy and in 41 (9.2%) women treated with a standard dressing (relative risk 0.50, 95% CI 0.30–0.84; number needed to treat 22; P = 0.007). The effect remained statistically significant when adjusted for BMI and other potential risk factors. Incisional negative pressure wound therapy significantly reduced wound exudate whereas no difference was found for dehiscence and quality of life between the two groups. Conclusion Prophylactic use of incisional negative pressure wound therapy reduced the risk of surgical site infection in obese women giving birth by caesarean section. Tweetable RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI. Tweetable RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI.
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Design Multicentre randomised controlled trial. Setting Five hospitals in Denmark. Population Obese women (prepregnancy body mass index (BMI) ≥30 kg/m2) undergoing elective or emergency caesarean section. Method The participants were randomly assigned to incisional negative pressure wound therapy or a standard dressing after caesarean section and analysed by intention‐to‐treat. Blinding was not possible due to the nature of the intervention. Main outcome measures The primary outcome was surgical site infection requiring antibiotic treatment within the first 30 days after surgery. Secondary outcomes included wound exudate, dehiscence and health‐related quality of life. Results Incisional negative pressure wound therapy was applied to 432 women and 444 women had a standard dressing. Demographics were similar between groups. Surgical site infection occurred in 20 (4.6%) women treated with incisional negative pressure wound therapy and in 41 (9.2%) women treated with a standard dressing (relative risk 0.50, 95% CI 0.30–0.84; number needed to treat 22; P = 0.007). The effect remained statistically significant when adjusted for BMI and other potential risk factors. Incisional negative pressure wound therapy significantly reduced wound exudate whereas no difference was found for dehiscence and quality of life between the two groups. Conclusion Prophylactic use of incisional negative pressure wound therapy reduced the risk of surgical site infection in obese women giving birth by caesarean section. Tweetable RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI. Tweetable RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI.</description><identifier>ISSN: 1470-0328</identifier><identifier>ISSN: 1471-0528</identifier><identifier>EISSN: 1471-0528</identifier><identifier>DOI: 10.1111/1471-0528.15413</identifier><identifier>PMID: 30066454</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Adult ; Antibiotics ; Bandages - statistics &amp; numerical data ; Birth ; Body mass index ; Caesarean section ; Cesarean section ; Cesarean Section - adverse effects ; Clinical trials ; Dehiscence ; Demography ; Denmark ; Dressings ; Evidence-based medicine ; Female ; General Obstetrics ; Humans ; incisional negative pressure wound therapy ; Infections ; Negative-Pressure Wound Therapy - methods ; Obesity ; Obesity - complications ; Obesity - surgery ; Pregnancy ; Pregnancy Complications - surgery ; Pressure ; Quality of life ; Risk Factors ; Standard of Care - statistics &amp; numerical data ; Statistical analysis ; Surgery ; surgical site infection ; Surgical site infections ; Surgical Wound Infection - etiology ; Surgical Wound Infection - prevention &amp; control ; Treatment Outcome ; Womens health ; Wound Healing ; Wounds</subject><ispartof>BJOG : an international journal of obstetrics and gynaecology, 2019-04, Vol.126 (5), p.628-635</ispartof><rights>2018 The Authors. published by John Wiley &amp; Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists</rights><rights>2018 The Authors. 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Design Multicentre randomised controlled trial. Setting Five hospitals in Denmark. Population Obese women (prepregnancy body mass index (BMI) ≥30 kg/m2) undergoing elective or emergency caesarean section. Method The participants were randomly assigned to incisional negative pressure wound therapy or a standard dressing after caesarean section and analysed by intention‐to‐treat. Blinding was not possible due to the nature of the intervention. Main outcome measures The primary outcome was surgical site infection requiring antibiotic treatment within the first 30 days after surgery. Secondary outcomes included wound exudate, dehiscence and health‐related quality of life. Results Incisional negative pressure wound therapy was applied to 432 women and 444 women had a standard dressing. Demographics were similar between groups. Surgical site infection occurred in 20 (4.6%) women treated with incisional negative pressure wound therapy and in 41 (9.2%) women treated with a standard dressing (relative risk 0.50, 95% CI 0.30–0.84; number needed to treat 22; P = 0.007). The effect remained statistically significant when adjusted for BMI and other potential risk factors. Incisional negative pressure wound therapy significantly reduced wound exudate whereas no difference was found for dehiscence and quality of life between the two groups. Conclusion Prophylactic use of incisional negative pressure wound therapy reduced the risk of surgical site infection in obese women giving birth by caesarean section. Tweetable RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI. 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numerical data</subject><subject>Statistical analysis</subject><subject>Surgery</subject><subject>surgical site infection</subject><subject>Surgical site infections</subject><subject>Surgical Wound Infection - etiology</subject><subject>Surgical Wound Infection - prevention &amp; control</subject><subject>Treatment Outcome</subject><subject>Womens health</subject><subject>Wound Healing</subject><subject>Wounds</subject><issn>1470-0328</issn><issn>1471-0528</issn><issn>1471-0528</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNqFks2P1CAYhxujcdfVszdD4sVLd6F8tPVgsm78zCbrQc_kHfoyw9pChXY382f5H0pnxol6kQvw8vAA-VEUzxk9Z7ldMFGzksqqOWdSMP6gOD1WHu7GtKS8ak6KJyndUspURfnj4oRTqpSQ4rT4-SWGcbPtwUzOEOeNSy546InHNUzuDskYMaU5IrkPs-_ItMEI45ZE7GaDaZmT6NJ3EizJ2NqZvDm5CbPMYrYGT8BOGIkBTBARPEmHuvMkrDAt6gH9awL5MFgPsFwlgu_C4BJ2xPTO77RTdNA_LR5Z6BM-O_Rnxbf3775efSyvbz58urq8Lo1QNS8tNK2xjQXZoBVV3YiWsrauJRqQiotVpyQVuSRtZQRUjNmqooy1YiXbWil-VrzZe8d5NWBn0E8Rej1GN0Dc6gBO_73i3Uavw51WslFM0Sx4dRDE8GPGNOn8HIN9Dx7DnHRFmxwal5xl9OU_6G2YY44hU6ypayZ522TqYk-ZGFKKaI-XYVQv30Ev4eslfL37DnnHiz_fcOR_558BuQfuXY_b__n02883e_EvzTzDHA</recordid><startdate>201904</startdate><enddate>201904</enddate><creator>Hyldig, N</creator><creator>Vinter, CA</creator><creator>Kruse, M</creator><creator>Mogensen, O</creator><creator>Bille, C</creator><creator>Sorensen, JA</creator><creator>Lamont, RF</creator><creator>Wu, C</creator><creator>Heidemann, LN</creator><creator>Ibsen, MH</creator><creator>Laursen, JB</creator><creator>Ovesen, PG</creator><creator>Rorbye, C</creator><creator>Tanvig, M</creator><creator>Joergensen, JS</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>ASE</scope><scope>FPQ</scope><scope>K6X</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201904</creationdate><title>Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4673-fa89cf8fa58ef427849019775eca5634bd65040195f2c4a211f2201194b597663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Antibiotics</topic><topic>Bandages - statistics &amp; numerical data</topic><topic>Birth</topic><topic>Body mass index</topic><topic>Caesarean section</topic><topic>Cesarean section</topic><topic>Cesarean Section - adverse effects</topic><topic>Clinical trials</topic><topic>Dehiscence</topic><topic>Demography</topic><topic>Denmark</topic><topic>Dressings</topic><topic>Evidence-based medicine</topic><topic>Female</topic><topic>General Obstetrics</topic><topic>Humans</topic><topic>incisional negative pressure wound therapy</topic><topic>Infections</topic><topic>Negative-Pressure Wound Therapy - methods</topic><topic>Obesity</topic><topic>Obesity - complications</topic><topic>Obesity - surgery</topic><topic>Pregnancy</topic><topic>Pregnancy Complications - surgery</topic><topic>Pressure</topic><topic>Quality of life</topic><topic>Risk Factors</topic><topic>Standard of Care - statistics &amp; numerical data</topic><topic>Statistical analysis</topic><topic>Surgery</topic><topic>surgical site infection</topic><topic>Surgical site infections</topic><topic>Surgical Wound Infection - etiology</topic><topic>Surgical Wound Infection - prevention &amp; control</topic><topic>Treatment Outcome</topic><topic>Womens health</topic><topic>Wound Healing</topic><topic>Wounds</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hyldig, N</creatorcontrib><creatorcontrib>Vinter, CA</creatorcontrib><creatorcontrib>Kruse, M</creatorcontrib><creatorcontrib>Mogensen, O</creatorcontrib><creatorcontrib>Bille, C</creatorcontrib><creatorcontrib>Sorensen, JA</creatorcontrib><creatorcontrib>Lamont, RF</creatorcontrib><creatorcontrib>Wu, C</creatorcontrib><creatorcontrib>Heidemann, LN</creatorcontrib><creatorcontrib>Ibsen, MH</creatorcontrib><creatorcontrib>Laursen, JB</creatorcontrib><creatorcontrib>Ovesen, PG</creatorcontrib><creatorcontrib>Rorbye, C</creatorcontrib><creatorcontrib>Tanvig, M</creatorcontrib><creatorcontrib>Joergensen, JS</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium &amp; 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Design Multicentre randomised controlled trial. Setting Five hospitals in Denmark. Population Obese women (prepregnancy body mass index (BMI) ≥30 kg/m2) undergoing elective or emergency caesarean section. Method The participants were randomly assigned to incisional negative pressure wound therapy or a standard dressing after caesarean section and analysed by intention‐to‐treat. Blinding was not possible due to the nature of the intervention. Main outcome measures The primary outcome was surgical site infection requiring antibiotic treatment within the first 30 days after surgery. Secondary outcomes included wound exudate, dehiscence and health‐related quality of life. Results Incisional negative pressure wound therapy was applied to 432 women and 444 women had a standard dressing. Demographics were similar between groups. Surgical site infection occurred in 20 (4.6%) women treated with incisional negative pressure wound therapy and in 41 (9.2%) women treated with a standard dressing (relative risk 0.50, 95% CI 0.30–0.84; number needed to treat 22; P = 0.007). The effect remained statistically significant when adjusted for BMI and other potential risk factors. Incisional negative pressure wound therapy significantly reduced wound exudate whereas no difference was found for dehiscence and quality of life between the two groups. Conclusion Prophylactic use of incisional negative pressure wound therapy reduced the risk of surgical site infection in obese women giving birth by caesarean section. Tweetable RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI. 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subjects Adult
Antibiotics
Bandages - statistics & numerical data
Birth
Body mass index
Caesarean section
Cesarean section
Cesarean Section - adverse effects
Clinical trials
Dehiscence
Demography
Denmark
Dressings
Evidence-based medicine
Female
General Obstetrics
Humans
incisional negative pressure wound therapy
Infections
Negative-Pressure Wound Therapy - methods
Obesity
Obesity - complications
Obesity - surgery
Pregnancy
Pregnancy Complications - surgery
Pressure
Quality of life
Risk Factors
Standard of Care - statistics & numerical data
Statistical analysis
Surgery
surgical site infection
Surgical site infections
Surgical Wound Infection - etiology
Surgical Wound Infection - prevention & control
Treatment Outcome
Womens health
Wound Healing
Wounds
title Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial
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