Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-28 @ 8:24 PM
Study NCT ID:
NCT03021668
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2017-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mweiss5@jhmi.edu', 'phone': '4106143368', 'title': 'Dr. Matthew J. Weiss', 'organization': 'Johns Hopkins Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was conducted at a high volume center for pancreatic surgery with a broad experience using Negative-Pressure Wound Therapy (NPWT), and therefore there is a question about the generalizability of the reductions we observed.'}}, 'adverseEventsModule': {'timeFrame': 'Within 90 days of surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Prevena Peel & Place Dressing for Wound Closure', 'description': 'In the participants randomized to this arm the surgical site will be closed using Prevena Peel \\& Place Dressing.\n\nPrevena Peel \\& Place Dressing: Prevena Peel \\& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 7, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Closure of the Wound', 'description': 'In the participants randomized to this arm the surgical site will be closed using the standard closure technique.\n\nStandard Closure of the Surgical Incision: This would involve standard closure of the incision site', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 15, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Postoperative pancreatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed gastric emptying', 'notes': 'Postoperative delayed gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative respiratory complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Surgical Site Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena Peel & Place Dressing for Wound Closure', 'description': 'In the participants randomized to this arm the surgical site will be closed using Prevena Peel \\& Place Dressing.\n\nPrevena Peel \\& Place Dressing: Prevena Peel \\& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound'}, {'id': 'OG001', 'title': 'Standard Closure of the Wound', 'description': 'In the participants randomized to this arm the surgical site will be closed using the standard closure technique.\n\nStandard Closure of the Surgical Incision: This would involve standard closure of the incision site'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Chi2 test was performed to analyze difference in rates of Surgical Site Infections (SSIs) between the two groups'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of the operation', 'description': 'Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prolonged Length of Stay, Measured in Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena Peel & Place Dressing for Wound Closure', 'description': 'In the participants randomized to this arm the surgical site will be closed using Prevena Peel \\& Place Dressing.\n\nPrevena Peel \\& Place Dressing: Prevena Peel \\& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound'}, {'id': 'OG001', 'title': 'Standard Closure of the Wound', 'description': 'In the participants randomized to this arm the surgical site will be closed using the standard closure technique.\n\nStandard Closure of the Surgical Incision: This would involve standard closure of the incision site'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': "Students' T-test was used to evaluate any difference in length of stay between the two groups."}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 10 days of surgery', 'description': 'Length of stay of patient at the hospital from date of surgery', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Readmission for Surgical Site Infections (SSIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena Peel & Place Dressing for Wound Closure', 'description': 'In the participants randomized to this arm the surgical site will be closed using Prevena Peel \\& Place Dressing.\n\nPrevena Peel \\& Place Dressing: Prevena Peel \\& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound'}, {'id': 'OG001', 'title': 'Standard Closure of the Wound', 'description': 'In the participants randomized to this arm the surgical site will be closed using the standard closure technique.\n\nStandard Closure of the Surgical Incision: This would involve standard closure of the incision site'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of operation', 'description': 'Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '30-d Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevena Peel & Place Dressing for Wound Closure', 'description': 'In the participants randomized to this arm the surgical site will be closed using Prevena Peel \\& Place Dressing.\n\nPrevena Peel \\& Place Dressing: Prevena Peel \\& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound'}, {'id': 'OG001', 'title': 'Standard Closure of the Wound', 'description': 'In the participants randomized to this arm the surgical site will be closed using the standard closure technique.\n\nStandard Closure of the Surgical Incision: This would involve standard closure of the incision site'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of surgery', 'description': 'Need for 30-day readmission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prevena Peel & Place Dressing for Wound Closure', 'description': 'In the participants randomized to this arm the surgical site will be closed using Prevena Peel \\& Place Dressing.\n\nPrevena Peel \\& Place Dressing: Prevena Peel \\& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound'}, {'id': 'FG001', 'title': 'Standard Closure of the Wound', 'description': 'In the participants randomized to this arm the surgical site will be closed using the standard closure technique.\n\nStandard Closure of the Surgical Incision: This would involve standard closure of the incision site'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prevena Peel & Place Dressing for Wound Closure', 'description': 'In the participants randomized to this arm the surgical site will be closed using Prevena Peel \\& Place Dressing.\n\nPrevena Peel \\& Place Dressing: Prevena Peel \\& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound'}, {'id': 'BG001', 'title': 'Standard Closure of the Wound', 'description': 'In the participants randomized to this arm the surgical site will be closed using the standard closure technique.\n\nStandard Closure of the Surgical Incision: This would involve standard closure of the incision site'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '66.1', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Neoadjuvant therapy', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'American Society of Anesthesiologists (ASA) class', 'classes': [{'categories': [{'title': 'ASA I/II', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'ASA III/IV', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The patients were graded according to the American Society of Anesthesiologists risk scoring system. Patients are scores between I and IV based on their operative risk.\n\nASA I: A normal healthy patient. ASA II: A patient with a mild systemic disease. ASA III: A patient with a severe systemic disease that is not life-threatening. ASA IV: A patient with a severe systemic disease that is a constant threat to life.', 'unitOfMeasure': 'Participants'}, {'title': 'Preincisional prophylactic antibiotic', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative biliary stenting', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-10', 'size': 412779, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-02T16:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2017-01-06', 'resultsFirstSubmitDate': '2019-01-02', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-23', 'studyFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Surgical Site Infection', 'timeFrame': 'Within 30 days of the operation', 'description': 'Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)'}], 'secondaryOutcomes': [{'measure': 'Prolonged Length of Stay, Measured in Days', 'timeFrame': 'Within 10 days of surgery', 'description': 'Length of stay of patient at the hospital from date of surgery'}, {'measure': 'Rate of Readmission for Surgical Site Infections (SSIs)', 'timeFrame': 'Within 30 days of operation', 'description': 'Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery'}, {'measure': '30-d Readmission', 'timeFrame': 'Within 30 days of surgery', 'description': 'Need for 30-day readmission'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgical Site Infection', 'Pancreatic Neoplasms', 'Pancreatic Cancer', 'Chemotherapy Effects', 'Chemoradiation', 'Surgical Wound', 'Wound Complication']}, 'descriptionModule': {'briefSummary': 'Pancreaticoduodenectomy is associated with high perioperative morbidity, with surgical site infection (SSIs) being one of the most common complications. A retrospective study at Hopkins on SSIs in these patients identified the rate of SSIs to be 16.7% and pre-operative bile stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site infection. Patients with these factors having a predicted risk of up to 32%. Another subsequent retrospective study demonstrated that the use of negative pressure wound therapy device was significantly associated with a decrease in the rate of SSIs.\n\nThe hypothesis of the investigator(s) for the current study is that placement of Prevena Peel \\& Place Dressing (Negative Pressure Wound Therapy, NPWT) in patients undergoing pancreaticoduodenectomy who are at high risk of SSIs will result in a significant decrease in their SSI rate.', 'detailedDescription': 'Although outcomes of pancreaticoduodenectomy have improved, it remains a procedure with a high perioperative complication rate. Surgical site infection is one of the most common complications after pancreaticoduodenectomy. In a retrospective review of all patients who underwent pancreaticoduodenectomy at Johns Hopkins between 9/2011 and 8/2014, a total of 679 patients, 30-day surgical site infection was observed in 16.7%. By univariate analysis, perioperative blood transfusion, operative time greater than 7 hours, preoperative chemotherapy and/or radiation, bile stent, absence of a superficial wound vacuum closure device, and vascular resection were associated with surgical site infection (all, p\\<0.05). On multivariable analysis, pre-operative bile stent/drain and neoadjuvant chemotherapy were independent predictors of surgical site infection (all, p\\<0.001). Studies in colorectal patients have found an estimated cost of up to $1400 per patient secondary to prolonged hospitalization, wound care, and wound complications in patients with procedures complicated by a surgical site infection. Furthermore, in another study of 1144 patients undergoing pancreaticoduodenectomy between 1995 and 2011 at Johns Hopkins Hospital, post-operative complications delayed time to adjuvant therapy, decreased median survival.\n\nThe hypothesis of the investigator(s) is that placement of Prevena Peel \\& Place Dressing using the standard Acelity vacuum dressing after suture on patients undergoing pancreaticoduodenectomy at highest risk of infection will result in a significant decrease in surgical site infection rate. The investigator(s) plan to perform a randomized control trial where the patients who have had pre-operative bile stent/drain placement and/or neoadjuvant chemotherapy will undergo closure with Prevena Peel \\& Place Dressing using the standard Acelity vacuum dressing after suture versus standard closure. The investigator(s) will then follow the participant(s) for 30 days postoperatively to determine surgical site infection and other perioperative complication rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient to undergo pancreaticoduodenectomy for pancreatic tumors at the Johns Hopkins Hospital\n* Patient treated with neoadjuvant chemotherapy with or without radiation therapy prior to surgical resection, AND/OR placement of a biliary stent and/or drain for biliary tree decompression\n\nExclusion Criteria:\n\n* Age 18 years or younger\n* Laparoscopic or robotic pancreaticoduodenectomy\n* Patient did not undergo either placement of a preoperative biliary stent/drain or neoadjuvant chemotherapy with or without radiation therapy\n* All patients who are have known allergies or are sensitive to silver and acrylic adhesives'}, 'identificationModule': {'nctId': 'NCT03021668', 'briefTitle': 'Comparison Between Wound Vacuum Dressing and Standard Closure to Reduce Rates of Surgical Site Infections', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Randomized Control Trial of Prevena Peel & Place Dressing Versus Standard Closure for Patients Undergoing Pancreaticoduodenectomy Who Have Undergone Neoadjuvant Chemotherapy or Biliary Stent Placement', 'orgStudyIdInfo': {'id': 'IRB00109564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevena Peel & Place Dressing for wound closure', 'description': 'In the participants randomized to this arm the surgical site will be closed using Prevena Peel \\& Place Dressing.', 'interventionNames': ['Device: Prevena Peel & Place Dressing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard closure of the wound', 'description': 'In the participants randomized to this arm the surgical site will be closed using the standard closure technique.', 'interventionNames': ['Other: Standard Closure of the Surgical Incision']}], 'interventions': [{'name': 'Prevena Peel & Place Dressing', 'type': 'DEVICE', 'description': 'Prevena Peel \\& Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound', 'armGroupLabels': ['Prevena Peel & Place Dressing for wound closure']}, {'name': 'Standard Closure of the Surgical Incision', 'type': 'OTHER', 'description': 'This would involve standard closure of the incision site', 'armGroupLabels': ['Standard closure of the wound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '212187', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Matthew J Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}