Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-04 @ 9:39 PM
Study NCT ID:
NCT02869204
Status:
UNKNOWN
Last Update Posted:
2016-08-16
First Post:
2016-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Local Injection of a Platelet Concentrate on Infection and Healing of Surgical Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D015032', 'term': 'Zinc'}, {'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-11', 'studyFirstSubmitDate': '2016-08-03', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with wound infection assessed by traditional clinical observation of the cicatrice', 'timeFrame': 'From date of surgery until the date of first documented event of infection or date of death from any cause, whichever came first, assessed up to 30 days .', 'description': 'Infection are defined as a collection of pus in the wound that require revision.\n\nIt is assessed by observation from the hospital staff.'}], 'secondaryOutcomes': [{'measure': 'Number of days before the surgical wound are full epithelized assessed by observation of the cicatrice', 'timeFrame': 'Up to 30 days', 'description': 'Digital photos of the cicatrice will be collected and analyzed for the amount of remaining scab.'}, {'measure': 'Other postoperative complications', 'timeFrame': 'Up to 30 days'}, {'measure': 'Length of stay (LOS)', 'timeFrame': '30 days'}, {'measure': 'Experience of pain assessed by a VAS (Visual analogue scale)', 'timeFrame': 'Up to 30 days'}, {'measure': 'Mobilization assessed by "Timed Up & Go (TUG)"', 'timeFrame': 'Up to 30 days', 'description': 'Timed Up \\& Go, also known as TUG, measures the time it takes a study subject to stand up, walk 3 meters, turn around, walk back and sit down.'}, {'measure': 'Inflammatory responds assessed by blood sample analysis of the acute phase reactant CRP (c-reactive protein)', 'timeFrame': 'Up to 30 days'}, {'measure': 'Inflammatory responds assessed by blood sample analysis of the acute phase reactant leucucytes', 'timeFrame': 'Up to 30 days'}]}, 'conditionsModule': {'conditions': ['Wound Infection and Wound Healing']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to investigate whether a combination of a local injection of platelet rich plasma (PRP) combined with a daily supplement of vitamin C, zinc, L-arginine, as well as high protein diet (1.5 g of protein per kilo body weight per day) can promote tissue healing in patients undergoing open upper-abdominal surgery.\n\nPrimary endpoint is cases of wound infection and secondary endpoints are time of tissue regeneration (days), judged by traditional clinical observation and experimentally assessed by ultrasound.\n\nThe experiment is performed as a parallel two-armed, randomized, controlled trial.\n\nA total of 40 subjects will be included in the trial i order to ensure the power of the study, despite a drop off of up to 25%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient at Rigshospitalets Surgical gastroenterology clinic\n* Planned to have a Pancreaticoduodenectomy preformed\n* Being able to understand Danish, the trial and what it means to be enrolled in the trial\n* Capable of signing a written consent\n* Living i the Regional Capital (excl. Bornholm) or the Regional of Sjælland (north of Næstved)\n\nExclusion Criteria:\n\n* Dysregulated diabetes mellitus type I or II\n* Alcohol consumption above 14 or 7 x 12 g alcohol per week (men vs women)\n* Participating in another clinical trial'}, 'identificationModule': {'nctId': 'NCT02869204', 'briefTitle': 'The Effect of a Local Injection of a Platelet Concentrate on Infection and Healing of Surgical Wounds', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effect of L-PRP on Wound Healing and Wound Infection After Pancreaticoduodenectomy / Whipples Surgery', 'orgStudyIdInfo': {'id': 'H-16025526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leucocyte - Platelet rich Plasma and Dietary Supplements', 'description': 'An application of an autologous platelet concentrate (20 ml). This is injected once, locally in the muscle after closure of the inner fascia and before closure of the outer fascia.\n\nA daily dietary supplement of Vitamin C, Zinc and L-Arginine. Provided from POD2-3 until POD30', 'interventionNames': ['Other: Leucocyte - Platelet rich Plasma', 'Dietary Supplement: Vitamin C', 'Dietary Supplement: Zinc', 'Dietary Supplement: L-Arginine']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Patients are treated as usual.'}], 'interventions': [{'name': 'Leucocyte - Platelet rich Plasma', 'type': 'OTHER', 'otherNames': ['L-PRP'], 'description': "Autologous L-PRP are studied regarding it's accelerating effect on tissue repair.", 'armGroupLabels': ['Leucocyte - Platelet rich Plasma and Dietary Supplements']}, {'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A daily dietary supplement of 500 mg Vitamin C. Provided from POD2-3 until POD30', 'armGroupLabels': ['Leucocyte - Platelet rich Plasma and Dietary Supplements']}, {'name': 'Zinc', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A daily dietary supplement of 44 mg Zinc. Provided from POD2-3 until POD30', 'armGroupLabels': ['Leucocyte - Platelet rich Plasma and Dietary Supplements']}, {'name': 'L-Arginine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A daily dietary supplement of 5 g L-Arginine. Provided from POD2-3 until POD30', 'armGroupLabels': ['Leucocyte - Platelet rich Plasma and Dietary Supplements']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Rikardt Andersen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}