Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:18 AM
Study NCT ID:
NCT07408960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2025-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013529', 'term': 'Surgical Wound Dehiscence'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010577', 'term': 'Petrolatum'}], 'ancestors': [{'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, placebo-controlled, within-subject (split-breast) interventional feasibility pilot study. All participants undergo bilateral breast reduction, with one breast randomized to receive CO2Lift® and the contralateral breast receiving a placebo. Randomization occurs at the breast level, and participants serve as their own control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2025-11-28', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rate', 'timeFrame': 'Through study recruitment completion, an average of 1 year', 'description': 'Number of participants enrolled per month during the recruitment period.'}, {'measure': 'Retention Rate', 'timeFrame': 'Up to 12 weeks postoperatively.', 'description': 'Proportion of enrolled participants completing the 12-week follow-up period.'}, {'measure': 'Incidence of Treatment-Related Adverse Events', 'timeFrame': 'Postoperative days 0-7 days', 'description': 'Number of participants experiencing any treatment-related adverse event, including local skin reactions.'}, {'measure': 'Incidence of Re-operation', 'timeFrame': 'Up to 12 weeks postoperatively', 'description': 'Number of participants requiring surgical re-intervention related to wound complications.'}], 'secondaryOutcomes': [{'measure': 'Incidence of T-Junction Breakdown', 'timeFrame': 'Up to 12 weeks postoperatively.', 'description': 'Presence of wound dehiscence at the T-junction, assessed by blinded adjudication (Proportion of breasts with breakdown (%)).'}, {'measure': 'Time to Wound Healing', 'timeFrame': 'Up to 12 weeks postoperatively', 'description': 'Number of days from surgery to complete epithelialization of the T-junction.'}, {'measure': 'Tissue Oxygen Saturation at the T-Junction', 'timeFrame': 'Postoperative days 0-6', 'description': 'Change in tissue oxygen saturation (StO₂) measured using near-infrared spectroscopy before and after treatment application.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound Breakdown', 'Breast Reduction', 'Surgical Wound', 'Breast Surgery']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot study is to determine the feasibility of a larger randomized controlled trial evaluating CO₂Lift® Pro Carboxy Gel to reduce wound breakdown after bilateral breast reduction in adult female patients undergoing elective bilateral breast reduction surgery. The main question it aims to answer is: Is it feasible to recruit, retain, and treat patients while maintaining blinding and monitoring safety?\n\nExploratory questions include: (1) Does CO₂Lift® reduce the incidence of wound breakdown compared with placebo? (2) Is CO₂Lift® safe and well-tolerated in the postoperative period?\n\nResearchers will compare CO₂Lift® applied to one breast to placebo (Vaseline®) applied to the contralateral breast to see if CO₂Lift® can improve wound healing and tissue oxygenation.\n\nParticipants will:\n\n* Undergo bilateral breast reduction surgery.\n* Receive CO₂Lift® on one breast and placebo on the other, starting immediately after surgery and daily in clinic from postoperative days 1 to 6.\n* Attend weekly postoperative follow-up visits for 12 weeks for wound assessment and monitoring of adverse events.\n* Have standardized photographs and near-infrared spectroscopy measurements taken to evaluate tissue oxygenation and healing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18 to 85 years\n* Undergoing bilateral reduction mammoplasty using an inverted-T (Wise pattern) technique\n* American Society of Anesthesiologists (ASA) physical status classification I-III\n* Able and willing to provide informed consent\n* Willing and able to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Prior radiation therapy to either breast\n* Prior breast reduction surgery to either breast\n* Known allergy or sensitivity to CO2Lift®, Vaseline®, or any of the ingredients\n* Pregnant or breastfeeding\n* History of immunosuppressive therapy\n* History of keloid formation\n* Active local or systemic infection at the time of surgery\n* Current smoker or history of substance abuse (including alcohol or illicit drugs)\n* Use of asymmetrical breast reduction techniques\n* Anticipated inability to complete follow-up or loss to follow-up'}, 'identificationModule': {'nctId': 'NCT07408960', 'acronym': 'CO2-BREAST', 'briefTitle': 'CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Evaluating the Effect of CO2Lift Pro® Carboxy Gel on T-Junction Breakdown Rates After Breast Reduction Surgery: A Feasibility Study', 'orgStudyIdInfo': {'id': 'REB25-0946'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated breast', 'description': 'CO2 Lift Pro® Carboxygel treated breast', 'interventionNames': ['Other: Carboxygel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo breast', 'description': 'Vaseline® control breast', 'interventionNames': ['Other: Vaseline']}], 'interventions': [{'name': 'Carboxygel', 'type': 'OTHER', 'otherNames': ['CO2 Lift Pro'], 'description': 'The gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days.', 'armGroupLabels': ['Treated breast']}, {'name': 'Vaseline', 'type': 'OTHER', 'otherNames': ['Petroleum jelly', 'Petrolatum'], 'description': 'Vaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days', 'armGroupLabels': ['Placebo breast']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Merry Faye Graff, MSc', 'role': 'CONTACT', 'email': 'merryfaye.graff1@ucalgary.ca', 'phone': '5876642280'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified individual participant data will not be shared outside the study team due to the small sample size and the potential risk of participant re-identification. Aggregate study results will be reported in publications and presentations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Justin Yeung', 'investigatorAffiliation': 'University of Calgary'}}}}