Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-27 @ 11:59 PM
Study NCT ID:
NCT07078669
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-22
First Post:
2025-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2025-07-11', 'studyFirstSubmitQcDate': '2025-07-11', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Erythema Assessment scale', 'timeFrame': '2 weeks post-procedure', 'description': 'Erythema will be assessed on both sides of the surgical wound using a 0-4 Clinical Erythema Assessment scale: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe with 0 being the better outcome and 4 the worst.'}, {'measure': 'Clinical Erythema Assessment scale', 'timeFrame': '4 weeks post-procedure', 'description': 'Erythema will be assessed on both sides of the surgical wound using a 0-4 Clinical Erythema Assessment scale: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe with 0 being the better outcome and 4 the worst.'}, {'measure': 'Clinical Erythema Assessment scale', 'timeFrame': '3 months post-procedure', 'description': 'Erythema will be assessed on both sides of the surgical wound using a 0-4 Clinical Erythema Assessment scale: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe with 0 being the better outcome and 4 the worst.'}, {'measure': 'Presence of Hypertrophic Scarring', 'timeFrame': '2 weeks post-procedure', 'description': 'Percentage of the presence of hypertrophic scarring. Visual clinical assessment of each side of the wound will document the presence or absence of hypertrophic scarring (yes/no). A lower percentage of presence of hypertrophic scarring is better than higher.'}, {'measure': 'Presence of Hypertrophic Scarring', 'timeFrame': '4 weeks post-procedure', 'description': 'Percentage of the presence of hypertrophic scarring. Visual clinical assessment of each side of the wound will document the presence or absence of hypertrophic scarring (yes/no). A lower percentage of presence of hypertrophic scarring is better than higher.'}, {'measure': 'Presence of Hypertrophic Scarring', 'timeFrame': '3 months post-procedure', 'description': 'Percentage of the presence of hypertrophic scarring. Visual clinical assessment of each side of the wound will document the presence or absence of hypertrophic scarring (yes/no). A lower percentage of presence of hypertrophic scarring is better than higher.'}, {'measure': 'Presence of Suture Extrusion', 'timeFrame': '2 weeks post-procedure', 'description': 'Presence of Suture Extrusion: Wound evaluation will record whether sutures are visibly extruding from the skin (yes/no) on each side of the wound, to compare extrusion frequency (percentage of suture extrusion being present) between suture types.'}, {'measure': 'Presence of Suture Extrusion', 'timeFrame': '4 weeks post-procedure', 'description': 'Presence of Suture Extrusion: Wound evaluation will record whether sutures are visibly extruding from the skin (yes/no) on each side of the wound, to compare extrusion frequency (percentage of suture extrusion being present) between suture types.'}, {'measure': 'Presence of Suture Extrusion', 'timeFrame': '3 Months post-procedure', 'description': 'Presence of Suture Extrusion: Wound evaluation will record whether sutures are visibly extruding from the skin (yes/no) on each side of the wound, to compare extrusion frequency (percentage of suture extrusion being present) between suture types.'}, {'measure': 'Presence of Surgical Site Infection', 'timeFrame': '2 weeks post-procedure', 'description': 'Presence of Surgical Site Infection: Wound will be evaluated for signs of infection (e.g. erythema, exudate, tenderness) and recorded as yes/no to compare infection frequency (percentage of infection being present) between suture types.'}, {'measure': 'Presence of Surgical Site Infection', 'timeFrame': '4 weeks post-procedure', 'description': 'Presence of Surgical Site Infection: Wound will be evaluated for signs of infection (e.g. erythema, exudate, tenderness) and recorded as yes/no to compare infection frequency (percentage of infection being present) between suture types.'}, {'measure': 'Presence of Surgical Site Infection', 'timeFrame': '3 Months post-procedure', 'description': 'Presence of Surgical Site Infection: Wound will be evaluated for signs of infection (e.g. erythema, exudate, tenderness) and recorded as yes/no to compare infection frequency (percentage of infection being present) between suture types.'}, {'measure': 'Presence of Edema', 'timeFrame': '2 weeks post-procedure', 'description': 'Presence of Edema: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Edema', 'timeFrame': '4 weeks post-procedure', 'description': 'Presence of Edema: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Edema', 'timeFrame': '3 months post-procedure', 'description': 'Presence of Edema: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Wound Induration', 'timeFrame': '2 weeks post-procedure', 'description': 'Presence of Wound Induration: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Wound Induration', 'timeFrame': '4 weeks post-procedure', 'description': 'Presence of Wound Induration: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Wound Induration', 'timeFrame': '3 months post-procedure', 'description': 'Presence of Wound Induration: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Hyperpigmentation', 'timeFrame': '2 weeks post-procedure', 'description': 'Presence of Hyperpigmentation: Visual observation will determine whether increased pigmentation is present at the wound site and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Hyperpigmentation', 'timeFrame': '4 weeks post-procedure', 'description': 'Presence of Hyperpigmentation: Visual observation will determine whether increased pigmentation is present at the wound site and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Hyperpigmentation', 'timeFrame': '3 months post-procedure', 'description': 'Presence of Hyperpigmentation: Visual observation will determine whether increased pigmentation is present at the wound site and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Exudate', 'timeFrame': '2 weeks post-procedure', 'description': 'Presence of Exudate: Each side of the wound (dyed and undyed) will be checked for exudate (fluid drainage) and recorded as yes/no to assess differences in wound response.'}, {'measure': 'Presence of Exudate', 'timeFrame': '4 weeks post-procedure', 'description': 'Presence of Exudate: Each side of the wound (dyed and undyed) will be checked for exudate (fluid drainage) and recorded as yes/no to assess differences in wound response.'}, {'measure': 'Presence of Exudate', 'timeFrame': '3 months post-procedure', 'description': 'Presence of Exudate: Each side of the wound (dyed and undyed) will be checked for exudate (fluid drainage) and recorded as yes/no to assess differences in wound response.'}, {'measure': 'Presence of Dehiscence', 'timeFrame': '2 weeks post-procedure', 'description': 'Presence of Dehiscence: Each side of the wound (dyed and undyed) will be checked for dehiscence (any separation or opening) at the site of closure and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Dehiscence', 'timeFrame': '4 weeks post-procedure', 'description': 'Presence of Dehiscence: Each side of the wound (dyed and undyed) will be checked for dehiscence (any separation or opening) at the site of closure and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Presence of Dehiscence', 'timeFrame': '3 months post-procedure', 'description': 'Presence of Dehiscence: Each side of the wound (dyed and undyed) will be checked for dehiscence (any separation or opening) at the site of closure and recorded as yes/no to compare frequency of presence between suture types.'}, {'measure': 'Failure to Epithelialize', 'timeFrame': '2 weeks post-procedure', 'description': 'Failure to Epithelialize: Each side of the wound (dyed and undyed) will be evaluated for failure to epithelialize (incomplete skin coverage) and recorded as yes/no to compare differences between suture types.'}, {'measure': 'Failure to Epithelialize', 'timeFrame': '4 weeks post-procedure', 'description': 'Failure to Epithelialize: Each side of the wound (dyed and undyed) will be evaluated for failure to epithelialize (incomplete skin coverage) and recorded as yes/no to compare differences between suture types.'}, {'measure': 'Failure to Epithelialize', 'timeFrame': '3 months post-procedure', 'description': 'Failure to Epithelialize: Each side of the wound (dyed and undyed) will be evaluated for failure to epithelialize (incomplete skin coverage) and recorded as yes/no to compare differences between suture types.'}, {'measure': 'Presence of Suture Granuloma', 'timeFrame': '2 weeks post-procedure', 'description': 'Presence of Suture Granuloma: Granuloma formation at the suture site will be visually identified and recorded as yes/no. Comparison will be made between dyed and undyed sides.'}, {'measure': 'Presence of Suture Granuloma', 'timeFrame': '4 weeks post-procedure', 'description': 'Presence of Suture Granuloma: Granuloma formation at the suture site will be visually identified and recorded as yes/no. Comparison will be made between dyed and undyed sides.'}, {'measure': 'Presence of Suture Granuloma', 'timeFrame': '3 months post-procedure', 'description': 'Presence of Suture Granuloma: Granuloma formation at the suture site will be visually identified and recorded as yes/no. Comparison will be made between dyed and undyed sides.'}, {'measure': 'Presence of Contact Dermatitis', 'timeFrame': '2 weeks post-procedure', 'description': 'Presence of Contact Dermatitis: Contact dermatitis will be assessed and graded on a standardized International Contact Dermatitis Research Group (ICDRG) grading scale: - (none), + (weak), ++ (strong), +++ (extreme), IR (irritant) with none being the best outcome. The grading will be used to compare reactions between the two suture types.'}, {'measure': 'Presence of Contact Dermatitis', 'timeFrame': '4 weeks post-procedure', 'description': 'Presence of Contact Dermatitis: Contact dermatitis will be assessed and graded on a standardized International Contact Dermatitis Research Group (ICDRG) grading scale: - (none), + (weak), ++ (strong), +++ (extreme), IR (irritant) with none being the best outcome. The grading will be used to compare reactions between the two suture types.'}, {'measure': 'Presence of Contact Dermatitis', 'timeFrame': '3 months post-procedure', 'description': 'Presence of Contact Dermatitis: Contact dermatitis will be assessed and graded on a standardized International Contact Dermatitis Research Group (ICDRG) grading scale: - (none), + (weak), ++ (strong), +++ (extreme), IR (irritant) with none being the best outcome. The grading will be used to compare reactions between the two suture types.'}, {'measure': 'Patient-Rated Pruritus', 'timeFrame': '2 weeks post-procedure', 'description': 'Patient-Rated Pruritus: Patient will rate itch severity on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.'}, {'measure': 'Patient-Rated Pruritus', 'timeFrame': '4 weeks post-procedure', 'description': 'Patient-Rated Pruritus: Patient will rate itch severity on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.'}, {'measure': 'Patient-Rated Pruritus', 'timeFrame': '3 months post-procedure', 'description': 'Patient-Rated Pruritus: Patient will rate itch severity on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.'}, {'measure': 'Patient-Rated Pain/Tenderness', 'timeFrame': '2 weeks post-procedure', 'description': 'Patient-Rated Pruritus: Patients will rate pain/tenderness on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.'}, {'measure': 'Patient-Rated Pain/Tenderness', 'timeFrame': '4 weeks post-procedure', 'description': 'Patient-Rated Pruritus: Patients will rate pain/tenderness on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.'}, {'measure': 'Patient-Rated Pain/Tenderness', 'timeFrame': '3 months post-procedure', 'description': 'Patient-Rated Pruritus: Patients will rate pain/tenderness on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wound Closure', 'Suture Materials']}, 'descriptionModule': {'briefSummary': 'Purpose - This exploratory, split-wound study aims to evaluate the potential difference in skin reactions to two different types of sutures, dyed and undyed, used to close wounds after surgery. The study will assess whether dyed sutures to elicit increased tissue reactivity like redness, itching, and scarring and whether undyed sutures may be more optimal for wound healing and cosmetic response. Enrollment into the study and data collection is expected to take approximately 3-6 months. Follow-up visits will be chosen at 2 weeks, 4 weeks, and 3 months post-surgery, which is standard practice for monitoring healing and checking for complications such as infection or abnormal scarring.\n\nPrimary Objective - The primary objective is to assess the response of wounds closed with both dyed and undyed sutures after cutaneous surgery to determine if there is a difference in wound healing and tissue reactivity with one compared to the other.\n\nEnrollment into the study and data collection is expected to take approximately 3-6 months. Follow-up visits will be chosen at 2 weeks, 4 weeks, and 3 months post-surgery, which is standard practice for monitoring healing and checking for complications such as infection or abnormal scarring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled for a standard of care surgical excision\n\nExclusion Criteria:\n\n* Patients who are unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT07078669', 'briefTitle': 'Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Comparison of Patient Outcomes With Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery', 'orgStudyIdInfo': {'id': '2504138740'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dyed Sutures', 'description': 'Polyglactin 910 (Vicryl) is an absorbable suture commonly utilized for cutaneous surgery; it is available in both dyed (violet) and undyed forms. This arm designates the Dyed Sutures.', 'interventionNames': ['Device: Polyglactin 910 (Dyed)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Undyed Sutures', 'description': 'Polyglactin 910 (Vicryl) is an absorbable suture commonly utilized for cutaneous surgery; it is available in both dyed (violet) and undyed forms. This arm designates the Undyed Sutures.', 'interventionNames': ['Device: Polyglactin 910 (Undyed)']}], 'interventions': [{'name': 'Polyglactin 910 (Dyed)', 'type': 'DEVICE', 'description': 'Half the wound for each participant will be sutured using Polyglactin 910 suture dyed (violet) with colorants such as D\\&C Violet No. 2 present.', 'armGroupLabels': ['Dyed Sutures']}, {'name': 'Polyglactin 910 (Undyed)', 'type': 'DEVICE', 'description': 'Half the wound for each participant will be sutured using Polyglactin 910 suture Undyed', 'armGroupLabels': ['Undyed Sutures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15370-7010', 'city': 'Waynesburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'WVU Medicine Waynesburg Dermatology', 'geoPoint': {'lat': 39.89646, 'lon': -80.17923}}], 'overallOfficials': [{'name': 'Sarah Camplbell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University-Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sarah Campbell', 'investigatorAffiliation': 'West Virginia University'}}}}