- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07647562
Comparison of Outcomes of Plantar vs Groin Full-Thickness Skin Graft for Correction of Congenital Syndactyly of Hand
Congenital syndactyly is a condition present at birth in which two or more fingers are joined together. Surgical correction was performed to separate the fingers, improve hand appearance, and support better hand function. After separation of the fingers, a skin graft is often needed to cover the skin defect created during surgery. Full-thickness skin grafts may be taken from different donor sites. The groin has commonly been used as a donor site, but groin skin may differ from hand skin in color and texture. The plantar area of the foot has been considered as an alternative donor site because it may provide better color and texture matching and the donor scar is usually less visible.
This randomized controlled study compared the outcomes of plantar full-thickness skin grafts with groin full-thickness skin grafts in children who underwent surgical correction for congenital simple complete syndactyly of the hand. The study was conducted in the Department of Plastic Surgery, Sheikh Zayed Hospital, Rahim Yar Khan. Children aged 1 to 10 years with congenital simple complete syndactyly who required surgical correction with skin grafting were enrolled after written informed consent was obtained from their guardians. Children with complex syndactyly, associated congenital syndromes, infections, skin diseases, previous surgery on the affected hand, or missing postoperative photographs were not included.
The participants were assigned to one of two treatment groups by sealed opaque envelopes using a lottery method. One group received a plantar full-thickness skin graft, while the other group received a groin full-thickness skin graft. All operations were performed by a consultant plastic surgeon according to standard surgical practice. Postoperative follow-up was carried out at 2 weeks, 4 weeks, and 6 weeks after surgery.
The main purpose of the study was to compare postoperative complications between the two graft methods. These complications included scar contracture, web creep, donor-site hypertrophic scarring, and delayed healing. Scar contracture referred to tightening or shrinking of the graft or surrounding tissues that could limit finger movement or cause deformity. Web creep referred to distal migration of the reconstructed web space after surgery. Donor-site complications included raised or thickened scarring and delayed wound healing. These outcomes were assessed during follow-up visits by a consultant plastic surgeon who was blinded to the treatment group.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Rahim Yar Khan, Punjab Province, Pakistan, 64200
- Sheikh Zayed Medical college/hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 1 to 10 years of either gender with congenital simple complete syndactyly
- Cases requiring surgical correction with skin grafting.
- Patients with no prior surgical intervention on the affected hand.
Exclusion Criteria:
- Patients with complex syndactyly or other systemic conditions, including congenital syndromes, infections and skin diseases
- Patients with missing postoperative photographs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I - Plantar Full-Thickness Skin Graft
Participants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a plantar full-thickness skin graft.
The graft was harvested from the plantar surface of the foot and used to cover the skin defect created after syndactyly release.
Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
|
Syndactyly release was performed under standard surgical protocol.
A full-thickness skin graft was harvested from the plantar surface of the foot and applied to the recipient defect after separation of the fused fingers.
|
|
Active Comparator: Group II - Groin Full-Thickness Skin Graft
Participants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a groin full-thickness skin graft.
The graft was harvested from the groin region and used to cover the skin defect created after syndactyly release.
Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
|
Syndactyly release was performed under standard surgical protocol.
A full-thickness skin graft was harvested from the groin region and applied to the recipient defect after separation of the fused fingers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Scar Contracture
Time Frame: 2 weeks, 4 weeks, and 6 weeks after surgery
|
Scar contracture was assessed as abnormal tightening or shrinkage of the graft or surrounding tissue after syndactyly correction, resulting in visible tightness, deformity, or limitation of finger movement at the surgical site.
It was graded as none, mild, moderate, or severe according to clinical examination of range of motion and visible contracture.
Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
|
2 weeks, 4 weeks, and 6 weeks after surgery
|
|
Frequency of Web Creep
Time Frame: 2 weeks, 4 weeks, and 6 weeks after surgery
|
Web creep was assessed as distal migration of the reconstructed web space beyond the expected anatomical location after syndactyly correction.
It was evaluated by visual inspection and measurement from the metacarpophalangeal joint crease to the web apex.
Web creep was categorized as absent, less than 5 mm, 5 to 10 mm, or more than 10 mm.
Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
|
2 weeks, 4 weeks, and 6 weeks after surgery
|
|
Frequency of Donor-Site Hypertrophic Scarring
Time Frame: 2 weeks, 4 weeks, and 6 weeks after surgery
|
Donor-site hypertrophic scarring was assessed as a raised, thickened, erythematous, or pruritic scar confined within the boundaries of the original donor-site wound.
It was evaluated through visual and tactile examination of the donor site.
The outcome was recorded as present or absent.
Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
|
2 weeks, 4 weeks, and 6 weeks after surgery
|
|
Frequency of Delayed Healing
Time Frame: 2 weeks, 4 weeks, and 6 weeks after surgery
|
Delayed healing was assessed as failure of complete epithelialization of the graft or donor-site wound within more than 3 weeks after surgery, or the presence of wound dehiscence, infection, necrosis, or persistent exudate.
The outcome was recorded according to clinical wound examination.
Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
|
2 weeks, 4 weeks, and 6 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aesthetic Outcome Score
Time Frame: 6 weeks after surgery
|
The aesthetic outcome of the operated hand was assessed using a 1 to 10 score by a consultant plastic surgeon blinded to the treatment group.
The score was based on cosmetic appearance, including scar quality, web space appearance, symmetry, and overall visual restoration of the hand.
Lower scores indicated poor aesthetic outcome, while higher scores indicated excellent cosmetic outcome.
|
6 weeks after surgery
|
|
Healing Time
Time Frame: Up to 6 weeks after surgery
|
Healing time was recorded as the total number of days required for complete epithelialization of the graft and donor-site wounds after surgery.
|
Up to 6 weeks after surgery
|
|
Guardian Satisfaction Score
Time Frame: 6 weeks after surgery
|
Guardian satisfaction with the surgical outcome was recorded using a visual analogue scale ranging from 1 to 10. Lower scores indicated poor satisfaction, while higher scores indicated greater satisfaction with the overall surgical outcome, including appearance, function, and healing of the operated hand.
|
6 weeks after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wardah Rehmat, Sheikh Zayed Medical college/Hospital, Rahimyar Khan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Sheikh ZMC/H6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Syndactyly of Hand
-
University of UtahCompletedCongenital Hand DeformitiesUnited States
-
University Hospital, LilleCompleted
-
Centre Hospitalier Universitaire VaudoisTerminated
-
Odense University HospitalOdense Patient Data Explorative NetworkRecruitingToe Joint Deformity | Clubfoot | Flatfoot | Trigger Finger | Syndactyly | Hand Deformities, Congenital | Tarsal Coalition | Congenital Talipes Equinovarus | Valgus Foot Deformity | Club Foot | Polydactyly Toe | Thumb Hypoplasia | Polydactyly; Fingers | Osteomyelitis of Hindfoot | Osteomyelitis of Midfoot | Congenital Talipes... and other conditionsDenmark
-
Russell Sage CollegeAlbany Medical CollegeEnrolling by invitation
-
University of UtahCompletedTriphalangeal Thumbs in the Pediatric Population: Long Term Outcomes Following Surgical InterventionPhalanx of Supernumerary Digit of Hand
-
Adichunchanagiri Institute of Medical Sciences,...Mysore Medical College and Research InstituteCompletedInjury of Extensor Tendon of Hand | Tendon AdhesionsIndia
-
Aswan University HospitalCompletedForearm | Hand | Wrist | Acquired Deformity of ElbowEgypt
-
Aswan University HospitalCompletedForearm | Hand | Wrist | Acquired Deformity of ElbowEgypt
-
Incyte CorporationTerminatedSolid Tumor MalignancyUnited States, France, Spain, United Kingdom, Italy, Japan, Israel, Denmark, Germany, Switzerland, South Korea
Clinical Trials on Plantar Full-Thickness Skin Graft
-
Markman Biologics CorporationUnknown
-
University of PittsburghArmed Forces Institute of Regenerative MedicineNot yet recruitingBurns | Surgical Injury | Contracture ScarUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Karolinska InstitutetUnknownPostoperative Pain | Ventral HerniaSweden
-
Asia UniversityActive, not recruitingSkin Thickness | Skin StiffnessTaiwan
-
Indonesia UniversityRecruitingBurn Degree Second | Burn Degree ThirdIndonesia
-
The Metis FoundationNot yet recruitingBurns | Wound of Skin
-
Lahore General HospitalEnrolling by invitationSkin Transplantation | Reconstructive Surgical ProceduresPakistan
-
First Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Avita MedicalUnited States Department of Defense; Royal Perth Hospital; MedDRA Assistance Inc and other collaboratorsCompleted