NCT07647562

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

Congenital syndactylySyndactyly of handFull-thickness skin graftPlantar full-thickness skin graftGroin full-thickness skin graft

Outcome Measures

Primary Outcomes (4)

  • Frequency of Scar Contracture

    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

    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

    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

    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 Outcomes (3)

  • Aesthetic Outcome Score

    6 weeks after surgery

  • Healing Time

    Up to 6 weeks after surgery

  • Guardian Satisfaction Score

    6 weeks after surgery

Study Arms (2)

Group I - Plantar Full-Thickness Skin Graft

EXPERIMENTAL

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.

Procedure: Plantar Full-Thickness Skin Graft

Group II - Groin Full-Thickness Skin Graft

ACTIVE COMPARATOR

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.

Procedure: Groin Full-Thickness Skin Graft

Interventions

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.

Group I - Plantar Full-Thickness Skin Graft

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.

Group II - Groin Full-Thickness Skin Graft

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with complex syndactyly or other systemic conditions, including congenital syndromes, infections and skin diseases
  • Patients with missing postoperative photographs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

Study Officials

  • Wardah Rehmat

    Sheikh Zayed Medical college/Hospital, Rahimyar Khan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 15, 2026

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 15, 2026

Record last verified: 2026-06

Locations